A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis

This study will evaluate the efficacy and safety of SIM0718 in adolescents (12- < 18 years) and adults (18-75 years) with moderate to severe AD.

Start Date15 Oct 2024

Sponsor / Collaborator

Simcere Pharmaceutical Group Ltd.

NCT06488755

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SIM0718 in Adults and Adolescents With Asthma

Phase III clinical study of SIM0718 asthma

Start Date10 Jul 2024

Sponsor / Collaborator

Simcere Pharmaceutical Group Ltd.

100 Clinical Results associated with Rademikibart

100 Translational Medicine associated with Rademikibart

100 Patents (Medical) associated with Rademikibart

Literatures (Medical) associated with Rademikibart

02 Jul 2024·Expert opinion on emerging drugs

Emerging drugs for the treatment of atopic dermatitis: a focus on phase 2 and phase 3 trials

Review

Author: Su, Malcolm ; Obed, Ogechi ; Chong, Albert C ; Ong, Peck Y

INTRODUCTION:

Atopic dermatitis (AD) is an inflammatory skin condition that affects millions of pediatric and adult patients with well-studied impact on morbidity and quality of life. Management occurs in a stepwise fashion beginning with preventative measures before immunomodulators are introduced. However, challenges remain in treatment of moderate-to-severe atopic dermatitis that is refractory to first- and second-line treatments and there are only few topical anti-inflammatory options, especially for pediatric patients.

AREAS COVERED:

New medications are required to address these gaps as lesions may persist despite treatment or patients may discontinue treatment due to actual or anticipated adverse effects of mainstay medications. Emerging research into the pathophysiology of AD and the immune system at large has provided opportunities for novel interventions aimed at stopping AD mechanisms at new checkpoints. Clinical trials for 36 agents currently in phase 2 or phase 3 are evaluated with particular focus on the studies for, B244, CBP-201, tapinarof, lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab as they explore novel pathways and have some of the most promising results.

EXPERT OPINION:

These clinical trials contribute to the evolution of AD treatment toward greater precision based on salient pathways with a particular focus on moderate-to-severe AD to enhance efficacy and minimize adverse effects.

01 Apr 2024·The Journal of allergy and clinical immunology

Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001)

Article

Author: Pan, Wubin ; Ho, Selwyn ; Song, Jing ; Silverberg, Jonathan I ; Strober, Bruce ; Wei, Zheng ; Guo, Jiawang ; Li, Pauline ; Yun, Jang ; Xu, Jinhua ; Simpson, Eric L ; Guttman-Yassky, Emma ; Collazo, Raúl ; Longphre, Malinda ; Williams, Belinda ; Feinstein, Brian

BACKGROUND:

Rademikibart (CBP-201) is a next-generation IL-4 receptor alpha-targeting antibody.

OBJECTIVE:

We sought to evaluate rademikibart in adults with moderate to severe atopic dermatitis.

METHODS:

A total of 226 patients were randomized, double-blind, to subcutaneous rademikibart (300 mg every 2 weeks [Q2W], 150 mg Q2W, 300 mg every 4 weeks [Q4W]; plus 600-mg loading dose) or placebo. Randomization began in July 2020. The trial was completed in October 2021.

RESULTS:

The WW001 phase 2 trial achieved its primary end point: significant percent reduction from baseline in least-squares mean Eczema Area Severity Index (EASI) to week 16 with rademikibart 300 mg Q2W (-63.0%; P = .0007), 150 mg Q2W (-57.6%; P = .0067), 300 mg Q4W (-63.5%; P = .0004) versus placebo (-39.7%). EASI scores decreased significantly with 300 mg Q2W and Q4W at the earliest assessment (week 2), with no evidence of plateauing by week 16. Significant improvements were also observed in secondary end points, including pruritus. Across the primary and secondary end points, efficacy tended to be comparable with 300 mg Q2W and Q4W dosing. Rademikibart and placebo had similar, low incidence of treatment-emergent adverse events (TEAEs) (48% vs 54%), serious TEAEs (1.8% vs 3.6%), TEAEs leading to treatment discontinuation (1.2% vs 1.8%), conjunctivitis of unspecified cause (2.9% vs 0%), herpes (0.6% vs 1.8%), and injection-site reactions (1.8% vs 1.8%). Although no discontinuations were attributed to coronavirus disease 2019, pandemic-related restrictions likely had an impact on trial conduct.

CONCLUSIONS:

Rademikibart was efficacious and well tolerated at Q2W and Q4W intervals. Q4W dosing is a more convenient frequency than approved for current therapies.

01 Dec 2023·Dermatology and therapy

A Mini Review of the Impact of Baseline Disease Severity on Clinical Outcomes: Should We Compare Atopic Dermatitis Clinical Trials?

Review

Author: Collazo, Raúl ; Silverberg, Jonathan I ; Ho, Selwyn

Based on clinical trials of systemic treatments in adults with moderate-to-severe atopic dermatitis (AD) reported between 2014 and 2023, we used linear regression to investigate relationships between baseline Eczema Area and Severity Index (EASI) scores and (1) study start date, (2) EASI response, and (3) rescue medication rates. Analysis 1 was conducted with all patients from monotherapy and combination therapy trials; analyses 2 and 3 used monotherapy trial placebo arms. Across 32 trials with a baseline inclusion criterion of EASI ≥ 16, baseline mean EASI scores decreased with study start date. The lowest and highest baseline mean EASI scores were 25.1 and 33.6 (median 21.1 and 30.5), reported for the WW001 Phase 2 trial of rademikibart (formerly CBP-201; start date, July 2020) and the SOLO1 Phase 3 trial of dupilumab (start date, December 2014), respectively. In placebo arms, lower baseline EASI scores tended to be associated with greater percent reductions in EASI scores at Week 16 and less rescue medication usage. The WW001 trial placebo arm had the lowest baseline EASI score (mean 25.2; median 22.1), lowest rescue medication rate (14.3%), and a large reduction in least squares mean EASI scores (- 39.7%) at Week 16. In summary, baseline mean EASI scores have decreased across clinical trials conducted during the last decade. Less severe AD at baseline tended to be associated with greater placebo response and less use of rescue medications in placebo arms. Intertrial differences in variables, such as baseline AD severity, limit the validity of indirectly comparing clinical trials.

News (Medical) associated with Rademikibart

01 Apr 2025

·www.globenewswire.com

Connect Biopharma Announces Positive Type C Meeting with the FDA for Rademikibart

– FDA aligned on plan to initiate parallel Phase 2 trials of rademikibart in patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation – – Expect to initiate both trials in Q2 2025 – SAN DIEGO, April 01, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect or Connect Biopharma), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation. “We are pleased to have the FDA’s alignment on our two parallel Phase 2 trials evaluating rademikibart in patients experiencing an acute exacerbation of asthma or COPD, an area where no biologic therapies have been approved or systematically studied,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “During our Type C meeting, the FDA acknowledged the unmet need for reducing recurrent exacerbations during the vulnerable 28-day period following an acute exacerbation of asthma or COPD. In our previously completed Phase 2 study for the maintenance treatment of asthma, a 600 mg subcutaneous (SC) loading dose of rademikibart was well-tolerated and delivered robust improvement in pulmonary function in less than 24 hours. This promising data suggests that rademikibart could provide meaningful and rapid benefit to the millions of patients who experience exacerbations of asthma or COPD and are seen in emergency departments or are hospitalized each year.” Based on the advice from the FDA at the meeting, Connect plans to begin enrolling patients in these trials during the second quarter of this year. The two parallel Phase 2 randomized, double-blind, placebo-controlled trials are expected to each enroll approximately 160 patients and include patients with uncontrolled, moderate-to-severe asthma or COPD with eosinophils ≥300 cells/µL who are experiencing an acute exacerbation. The trials are designed to evaluate the benefits of a single 600 mg SC dose of rademikibart in patients over 28 days following an acute exacerbation. Based on the results of a recently published trial of a similar design, approximately 45% of patients receiving the current standard of care experienced treatment failure in the 28 days following an acute exacerbation, demonstrating the continued unmet need for better treatments for these patients1. Connect expects to report data from both rademikibart Phase 2 trials in the first half of 2026 with a cash runway into 2027. “Asthma and COPD patients face a heightened risk of further exacerbations within the first 28 days following an initial episode. While biologics have demonstrated significant success in maintenance therapy, none have been approved to address airway symptoms immediately after an acute exacerbation,” said Mario Castro, MD, MPH, Professor and Chief of Pulmonary, Critical Care and Sleep Medicine at the University of Kansas School of Medicine. “The pulmonology community is encouraged by the plan to evaluate the potential benefits of a single 600 mg SC dose of rademikibart following an acute exacerbation in these Phase 2 trials in patients with asthma and COPD.” About Connect Biopharma and Rademikibart Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the company is advancing rademikibart, a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. With an initial focus on acute exacerbations—an area with significant unmet need—rademikibart has the potential to also drive chronic utilization in asthma and COPD amongst the approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually. In a Phase 2 trial for asthma, rademikibart demonstrated strong efficacy and safety data, with clinically meaningful reductions in exacerbations and rapid, statistically significant improvements in FEV1, observed within one week—and in most cases, within 24 hours via home spirometry. For more information visit www.connectbiopharm.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the “Act”). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial condition, results of operations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, and adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the PRC, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community. Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the U.S. Securities and Exchange Commission (the “SEC”). Further information regarding these and other risks is included under the heading “Risk Factors” in our periodic reports filed with the SEC, including in our annual report on Form 10-K for the year ended December 31, 2024, and any subsequent filings with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date of this presentation. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements. This press release discusses product candidates that are under clinical study, and which have not yet been approved for marketing by the U.S. Food and Drug Administration or by any other regulatory agency. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Investor Relations Contact: Alex Lobo Precision AQ Alex.lobo@precisionaq.com(212) 698-8802 Media Contact: Ignacio Guerrero-Ros, Ph.D., or David SchullRusso Partners, LLCIgnacio.guerrero-ros@russopartnersllc.comDavid.schull@russopartnersllc.com(858) 717-2310 or (646) 942-5604 Ramakrishnan S, et.al. Treating eosinophilic exacerbations of asthma and COPD with benralizumab (ABRA): a double-blind, double-dummy, active placebo-controlled randomised trial. Lancet 2025; 13(1): 59-68.

Phase 2Clinical Result

31 Mar 2025

·www.globenewswire.com

Connect Biopharma Reports 2024 Full-Year Financial Results and Provides Business Update

Strengthened leadership team with key appointments, including Barry Quart, Pharm.D. as CEO, and David Szekeres as President, bringing deep clinical, regulatory, operational and strategic expertise Unveiled rapid clinical development program for rademikibart initially targeting acute care in asthma and COPD; expect to initiate parallel Phase 2 trials in 2Q 2025 with data expected in 2H 2026 Strong balance sheet with cash runway into 2027 and through key clinical catalysts SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma”, “Connect” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care in asthma and chronic obstructive pulmonary disease (COPD), today reported financial results for the year ended December 31, 2024, and provided a business update. “2024 was a transformative year for Connect as we strengthened our leadership team, made significant progress in becoming more U.S.-centric, and unveiled a rapid clinical development strategy for rademikibart initially focused on the treatment of acute asthma and COPD exacerbations, an area where no biologic therapies have been approved. To date, rademikibart has demonstrated a differentiated clinical profile in Phase 2 clinical trials achieving rapid improvement in pulmonary function in less than 24 hours, which was sustained through 24 weeks, highlighting its potential in both acute and chronic care,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “We are on track to initiate parallel Phase 2 trials of rademikibart as an adjunct to standard of care for the treatment of acute asthma and COPD exacerbations in the second quarter of 2025, with data expected in the second half of 2026. We believe rademikibart has the potential to fundamentally alter the treatment paradigm for millions of asthma and COPD patients who experience acute exacerbations every year.” Recent Highlights Clinical Program Highlights Parallel acute exacerbation trials of rademikibart as an adjunct to standard of care in asthma and COPD are on track to be initiated in the second quarter of 2025, with data expected in the second half of 2026. Corporate Highlights The Company continued making progress in becoming more U.S.-centric, including by: assembling an experienced U.S. management team with deep expertise in drug development and regulatory execution, including having collectively received U.S. Food and Drug Administration (FDA) marketing approval for 16 therapeutic products, and with deep expertise in business development, corporate strategy, finance and operations;relocating its corporate headquarters to San Diego, California, a leading global hub for innovative biopharmaceutical companies;transferring the initial manufacturing process for rademikibart to a U.S.-based contract manufacturing organization; andtransitioning to a U.S.-based independent registered accounting firm and voluntarily electing to become a domestic filer with the U.S. Securities and Exchange Commission (SEC), beginning with the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and on an ongoing basis with the regular filing of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Financial Results for the Year Ended December 31, 2024 Cash, cash equivalents and short-term investments were $93.7 million as of December 31, 2024. Based on its current operating plans, the Company expects that its cash, cash equivalents and short-term investments will be sufficient to fund operations into 2027.Revenue for the year ended December 31, 2024, totaled $26.0 million, which included revenue recognized for the upfront fee, development milestones and cost reimbursements in connection with the license agreement with Simcere Pharmaceutical Co., Ltd. There was no comparable activity for the year ended December 31, 2023.Research and Development expense for the year ended December 31, 2024, was $29.3 million, compared with $53.0 million for the same period in 2023, a decrease of $23.7 million. The decrease in Research and Development expense was primarily due to the completion in late 2023 of the rademikibart global Phase 2b program in patients with chronic asthma and the rademikibart China pivotal trials for patients with atopic dermatitis.General and Administrative expense for the year ended December 31, 2024, was $19.2 million, compared with $16.1 million for the same period in 2023, an increase of $3.1 million. The increase in General and Administrative expense was primarily due to costs associated with executive departures, including cash severance and non-cash, share-based compensation expense related to certain stock option modifications.Net loss was $15.6 million, or $0.28 per share, for the year ended December 31, 2024, compared with a net loss of $62.1 million, or $1.13 per share, for the same period in 2023. About Connect Biopharma and Rademikibart Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. With an initial focus on acute exacerbations—an area with significant unmet need—rademikibart has the potential to also drive chronic utilization in asthma and COPD amongst the millions of asthma and COPD patients in the U.S. who experience acute exacerbations annually. In a Phase 2 trial for asthma, rademikibart demonstrated strong efficacy and safety, with clinically meaningful reductions in exacerbations and rapid, statistically significant improvements in forced expiratory volume in one second, observed within one week—and in most cases, within 24 hours via home spirometry. For more information, visit www.connectbiopharm.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the “Act”). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our cash balance, financial guidance, future financial and operating results and related expectations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, and adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the timing and amount of actual expenses, including, without limitation, our anticipated combined U.S. GAAP R&D and G&A expenses; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the People’s Republic of China, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community. Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the SEC. Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date of this presentation. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements. This press release discusses product candidates that are under clinical study, and which have not yet been approved for marketing by the FDA or by any other regulatory agency. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Connect Biopharma Holdings LimitedCondensed Consolidated Statements of Operations(in thousands, except per share amounts)(unaudited) Years Ended December 31, 2024 2023 Revenue: License and collaboration revenues$26,033 $- Total revenue 26,033 - Operating expenses: Research and development expense 29,256 53,002 General and administrative expense 19,229 16,054 Total operating expenses 48,485 69,056 Loss from operations (22,452) (69,056)Total other income, net 7,047 7,070 Net loss before income tax (15,405) (61,986)Income tax expense 223 120 Net loss$ (15,628) $(62,106)Basic and diluted net loss per ordinary share$ (0.28) $(1.13)Weighted-average ordinary shares outstanding, basic and diluted 55,213 55,067 Connect Biopharma Holdings LimitedCondensed Consolidated Balance Sheet Data(in thousands)(unaudited) December 31, 2024 2023 Cash, cash equivalents and short-term investments$93,708 $118,303Total assets$101,284 $127,375Total shareholders' equity$92,166 $101,497 Investor Relations Contact: Alex Lobo Precision AQ Alex.lobo@precisionaq.com(212) 698-8802 Media Contact: Ignacio Guerrero-Ros, Ph.D., or David SchullRusso Partners, LLCIgnacio.guerrero-ros@russopartnersllc.comDavid.schull@russopartnersllc.com(858) 717-2310 or (646) 942-5604

Phase 2Financial StatementExecutive ChangeLicense out/in

06 Nov 2024

·www.prnewswire.com

Severe Asthma Clinical Trial Pipeline Appears Robust With 40+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

The severe asthma market is fueled by the rising prevalence of the condition, particularly in urban areas, alongside the emergence of innovative therapies like biologics targeting IgE and cytokine modulators. A growing demand for personalized medicine enhances treatment efficacy and patient compliance. Government initiatives and increased awareness improve access to care, while advancements in inhaler technology boost medication adherence. Collaborative efforts in R&D are also vital for driving innovation in asthma treatments. LAS VEGAS, Nov. 6, 2024 /PRNewswire/ -- DelveInsight's ' Severe Asthma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline severe asthma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the severe asthma pipeline domain. Key Takeaways from the Severe Asthma Pipeline Report DelveInsight's severe asthma pipeline report depicts a robust space with 40+ active players working to develop 50+ pipeline therapies for severe asthma treatment. Key severe asthma companies such as Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others are evaluating new severe asthma drugs to improve the treatment landscape. Promising severe asthma pipeline therapies such as KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others are under different phases of severe asthma clinical trials. In September 2024, Kinaset Therapeutics announced two oral presentations and a late-breaking poster presentation at the 2024 European Respiratory Society (ERS) Congress. The presentations demonstrate the potential of Kinaset's lead clinical candidate, frevecitinib ( KN-002), to treat all patients with moderate to severe asthma and patients with COPD. In May 2024, GSK announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterized by blood eosinophil count. In April 2024, Twenty-five abstracts across approved and investigational medicines will be presented at this year's American Thoracic Society (ATS) International Conference. Notable data presentations for Sanofi's immunology pipeline include the first presentation of phase IIb moderate to severe asthma data for rilzabrutinib. In October 2023, Upstream Bio announced positive interim results in its Phase Ib clinical study of UPB-101, a thymic stromal lymphopoietin receptor (TSLPR) inhibitor. The Phase Ib study is a randomized, double-blinded, placebo-controlled multiple ascending dose (MAD) study with subcutaneous (SC) administration conducted in asthma patients. In October 2023, Aiolos Bio with an asthma drug in clinical trials, announced that it raised $245 million in Series A funding. Atlas Venture, Bain Capital Life Sciences, Forbion Capital Partners and Sofinnova Investments led the round, with additional investment from RA Capital Management Request a sample and discover the recent advances in severe asthma treatment drugs @ Severe Asthma Pipeline Report The severe asthma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage severe asthma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the severe asthma clinical trial landscape. Severe Asthma Overview Severe asthma is a chronic respiratory condition characterized by persistent symptoms that are difficult to control, even with high-dose medications. Unlike milder forms of asthma, severe asthma can significantly impair the quality of life and may result in frequent exacerbations requiring hospitalization. The exact cause of severe asthma is not entirely clear, but it often arises from a combination of genetic and environmental factors. These may include respiratory infections, allergens (pollen, mold, dust mites), pollutants (tobacco smoke, air pollution), occupational irritants, and lifestyle factors such as obesity and stress. Severe asthma can also develop in people whose milder asthma is not well-controlled over time. Diagnosis of severe asthma begins with a comprehensive medical history, physical examination, and pulmonary function tests like spirometry to assess lung function. Doctors may also order additional tests, such as chest X-rays, blood tests, and allergy tests to identify triggers. A key factor in diagnosing severe asthma is the persistence of symptoms despite the optimal use of standard asthma treatments. Managing severe asthma typically requires a multifaceted approach. Inhaled corticosteroids and long-acting bronchodilators are the mainstays of treatment. For those who do not respond to these medications, biologic therapies (such as omalizumab, mepolizumab, or dupilumab) may be prescribed to target specific pathways involved in the inflammatory response. In addition, patients with severe asthma may benefit from lifestyle modifications, including weight management, avoiding triggers, and pulmonary rehabilitation. In extreme cases, systemic corticosteroids may be necessary, although long-term use can have serious side effects. Find out more about severe asthma treatment drugs @ Drugs for Severe Asthma Treatment A snapshot of the severe asthma Pipeline Drugs mentioned in the report: Learn more about the emerging severe asthma pipeline therapies @ Severe Asthma Clinical Trials Severe Asthma Therapeutics Assessment The severe asthma pipeline report proffers an integral view of the severe asthma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Severe Asthma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interleukin 5 receptor antagonists, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin modulators, Interleukin 6 inhibitors, STAT6 transcription factor degraders, Interleukin 4 receptor alpha subunit antagonists Key Severe Asthma Companies: Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others. Key Severe Asthma Pipeline Therapies: KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others. Dive deep into rich insights for new drugs for severe asthma treatment, visit @ Severe Asthma Drugs Table of Contents For further information on the severe asthma pipeline therapeutics, reach out @ Severe Asthma Treatment Drugs Related Reports Severe Asthma Market Severe Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key severe asthma companies including AstraZeneca plc, GlaxoSmithKline plc, Sanofi S.A., Novartis AG, Roche Holding AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., Boehringer Ingelheim International GmbH, Regeneron Pharmaceuticals, Inc., Johnson & Johnson, Pfizer Inc., Bristol Myers Squibb, Eli Lilly and Company, Vertex Pharmaceuticals Incorporated, Amgen Inc., AbbVie Inc., Genentech, Inc., Gilead Sciences, Inc., Biogen Inc., CSL Limited, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Phase 1

100 Deals associated with Rademikibart

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	China	Simcere Pharmaceutical Group Ltd.	10 Jul 2024
Eosinophilic Asthma	Phase 3	China	Simcere Pharmaceutical Group Ltd.	10 Jul 2024
Severe asthma	Phase 3	China	Suzhou Connect Biopharma Co. Ltd.	01 Jul 2024
Moderate Atopic Dermatitis	Phase 3	-	Suzhou Connect Biopharma Co. Ltd.	01 Dec 2022
Severe Atopic Dermatitis	Phase 3	-	Suzhou Connect Biopharma Co. Ltd.	01 Dec 2022
Asthma chronic	Phase 3	China	Suzhou Connect Biopharma Co. Ltd.	-
Acute asthma	Phase 2	-	Suzhou Connect Biopharma Co. Ltd.	01 May 2025
Pulmonary Disease, Chronic Obstructive	Phase 2	-	Suzhou Connect Biopharma Co. Ltd.	01 May 2025
Chronic rhinosinusitis with nasal polyps	Phase 2	United States	Suzhou Connect Biopharma Co. Ltd.	16 Jun 2021
Chronic rhinosinusitis with nasal polyps	Phase 2	China	Suzhou Connect Biopharma Co. Ltd.	16 Jun 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04773678 (Pubmed \| Am J Respir Crit Care Med)	Phase 2	blood eosinophils	322	Rademikibart 150 mg	bznykwyhlb(mjlmyrkygr) = pfdzydmytd iqczwenfeq (qfcmvlclmh, 44 - 236) View more	Positive	25 Feb 2025
				Rademikibart 300 mg	bznykwyhlb(mjlmyrkygr) = otnbtzggof iqczwenfeq (qfcmvlclmh, 92 - 286) View more
NCT05017480 (CN002 \| CBP-201-CN002, CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	330	CBP-201 (Group A: CBP-201 300mg Q2W)	luncirwbpv = bcuubmpzcy cxkoolegzt (wrtbnnexsf, ymrlmptuzf - ibpepxsuvb) View more	-	01 May 2024
				Placebo (Group B: Placebo Q2W)	luncirwbpv = xmlagtgibw cxkoolegzt (wrtbnnexsf, rzbrqyaaqu - wrvmrlblsl) View more
NCT04773678 (GlobeNewswire) Manual	Phase 2	Persistent asthma	322	Placebo	uyatpmvpjv(tlgfinluie) = pirnbrnmik emteerfpnf (nhkehhmrwx )	Positive	12 Dec 2023
				rademikibart 150 mg	uyatpmvpjv(tlgfinluie) = poansjibks emteerfpnf (nhkehhmrwx ) View more
NCT05017480 (CN002, Corporate Publications) Manual	Phase 2	Dermatitis, Atopic	330	Rademikibart300 mg Q4W (In patients that achieved IGA 0/1 or EASI-75 at Week 16)	wxyjfmdmnv(zvkjizdmvk) = fywocjlale jwugnnwlrd (nkgjsidfwm ) View more	Positive	21 Nov 2023
				Rademikibart 300 mg Q2W (In patients that achieved IGA 0/1 or EASI-75 at Week 16)	wxyjfmdmnv(zvkjizdmvk) = sagehdmvca jwugnnwlrd (nkgjsidfwm ) View more
NCT04444752 (CBP-201-WW001, CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	226	placebo	smxbvldbnb(mnqfboozzj) = fxkkiliiew lrakmtuqhx (qndqjckrai, 4.638) View more	-	01 Aug 2023
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	vnalvujffj(rosmofftcs) = sjdrrmtsyx kanyniasqj (okrjhumimn ) View more	-	03 Jul 2023
				Placebo	vnalvujffj(rosmofftcs) = gmoowyczua kanyniasqj (okrjhumimn ) View more
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	cufoeevqlg(cizarulvca) = yvnoodaabk nxwflreadh (dpkayoxqji ) View more	-	03 Jul 2023
				Placebo	cufoeevqlg(cizarulvca) = ihrdopjyhh nxwflreadh (dpkayoxqji ) View more
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	dilxpxrcdd(uhmpvwgcfq) = defiihdrnl bapcgjvskl (pfkrmjbxpo )	Positive	03 Jul 2023
				Placebo	dilxpxrcdd(uhmpvwgcfq) = ylqhjsyjfk bapcgjvskl (pfkrmjbxpo )
NCT05017480 (CN002, Corporate Publications) Manual	Phase 2	Dermatitis, Atopic	255	CBP-201	ltmjuxtyxz(jsffycrvag) = jzqeedjdkx uiqfrbbrhm (kbixjdflxd ) View more	Positive	04 Oct 2022
				Placebo	ltmjuxtyxz(jsffycrvag) = gttenalgsv uiqfrbbrhm (kbixjdflxd ) View more
NCT04444752 (CBP-201-WW001, EADV2022)	Phase 2	Dermatitis, Atopic	226	CBP-201 300mg Q2W	feaqygmfam(efteqgeorb) = wtljzkqtzi tjtjrufpdj (ayrojskpzq )	-	07 Sep 2022
				CBP-201 150mg Q2W	feaqygmfam(efteqgeorb) = stpcjrqloj tjtjrufpdj (ayrojskpzq )

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