Delving into the Latest Updates on Rademikibart with Synapse

Prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV₁) at Week 12 (primary endpoint) improved with rademikibart 150 mg and 300 mg: least squares mean changes (95% CI), above placebo, were +140 mL (+44-236 mL; p=0.005) and +189 mL (+92-286 mL; p<0.001), respectively. Prebronchodilator trough FEV₁ improvements occurred rapidly during Week 1, were sustained through Week 24, and greatest in patients with high baseline blood eosinophils (patients with ≥300 eosinophils/mL experienced placebo-adjusted FEV₁ improvement at Week 24 of +420 mL [95% CI, +239-600 mL] in the 300 mg group). Rapid and sustained statistically significant improvements were also observed in percent predicted FEV₁ and Asthma Control Questionnaire score across 24 weeks. Through Week 24, proportions of patients with ≥1 exacerbation were 7.5% (150 mg) and 9.3% (300 mg) vs 16.7% (placebo). 88% of patients completed treatment. Treatment-emergent adverse events (TEAEs) were generally similar to placebo, and no eosinophilia was observed. Injection site reactions were mostly mild. The most common TEAEs (10-12% of patients) were cough, COVID-19, and dyspnea.

CONCLUSIONS:

Rapid and sustained improvements in lung function and asthma control were gained across 24 weeks of rademikibart therapy. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/). Clinical trial registration available at www.

CLINICALTRIALS:

gov, ID: NCT04773678.

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 ; Li, Pauline ; Guo, Jiawang ; 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.

68

News (Medical) associated with Rademikibart

13 Jun 2025

·pipelinereview.com

Connect Biopharma Presents Data Supporting Rademikibart at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress

– Rademikibart significantly improved lung function and asthma control in patients with eosinophilic-driven type 2 asthma – – Rademikibart reduced annualized exacerbations in patients with eosinophilic-driven type 2 asthma – – Data supports ongoing Phase 2 acute exacerbation studies in asthma and COPD; expect to report topline data from both studies in 1H26 – SAN DIEGO, CA, USA I June 13, 2025 I Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced the presentation of clinical data supporting rademikibart, the Company’s investigational, next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody, at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually. “The data being presented today at EAACI continues to demonstrate the potential of rademikibart to deliver best-in-class efficacy for asthma patients,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “Building on the previously reported data from our Phase 2b asthma study, these analyses highlight rademikibart’s capability to not only rapidly deliver improvements in lung function, but also significantly reduce annualized asthma exacerbation rates, particularly in those with high eosinophil and fractional exhaled nitric oxide or FeNO counts, key markers of type 2 inflammation. We believe these findings continue to bolster support for our rapid Phase 2 clinical development plan and we look forward to reporting topline data from our parallel Seabreeze STAT studies in the first half of 2026.” Abstract Title: Improvement in Lung Function with Rademikibart in Eosinophilic Driven, Type 2 Asthma Abstract Number: 001678 Presenter: Rekha Chaudhuri, M.D. Session Title: Clinical Trials on Airways Diseases Date and Time: Friday, June 13 th from 3:00 p.m. – 4:30 p.m. BST Abstract Title: Reduction in Annualized Exacerbations with Rademikibart in Eosinophilic Driven, Type 2 Asthma Abstract Number: 001671 Presenter: Rekha Chaudhuri, M.D. Session Title: Clinical Trials on Airways Diseases Date and Time: Friday, June 13 th from 3:00 p.m. – 4:30 p.m. BST The presentations are available on Connect’s website under the presentations and publications section . 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 forced expiratory volume in one second (FEV 1 ), observed within one week—and in most cases, within 24 hours via home spirometry. For more information visit www.connectbiopharm.com . SOURCE: Connect Biopharma

Phase 2Clinical ResultImmunotherapy

03 Jun 2025

·www.globenewswire.com

Connect Biopharma Announces Two Oral Presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress

SAN DIEGO, June 03, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced two oral presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually. The presentation details are as follows: Abstract Title: Reduction in Annualized Exacerbations with Rademikibart in Eosinophilic Driven, Type 2 AsthmaAbstract Number: 001671Presenter: Rekha Chaudhuri, M.D.Session Title: Clinical Trials on Airways DiseasesDate and Time: Friday, June 13th from 3:00 p.m. – 4:30 p.m. BST Abstract Title: Improvement in Lung Function with Rademikibart in Eosinophilic Driven, Type 2 AsthmaAbstract Number: 001678Presenter: Rekha Chaudhuri, M.D.Session Title: Clinical Trials on Airways DiseasesDate and Time: Friday, June 13th from 3:00 p.m. – 4:30 p.m. BST Following the presentations, each presentation will be available on Connect’s website under the presentations and publications section. About Connect Biopharma and RademikibartConnect 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 forced expiratory volume in one second (FEV1), observed within one week—and in most cases, within 24 hours via home spirometry. For more information visit www.connectbiopharm.com. 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.com David.schull@russopartnersllc.com (858) 717-2310 or (646) 942-5604

Phase 2Immunotherapy

21 May 2025

·pipelinereview.com

Connect Biopharma Presents Data Supporting Development of Rademikibart at the American Thoracic Society (ATS) 2025 International Conference

– Rademikibart significantly improved airway function, as measured by FEV 1 , within a day and significantly reduced acute exacerbations in patients with inflammation-mediated chronic asthma strongly supporting ongoing Phase 2 acute exacerbation studies in asthma and COPD which are expected to report topline data in 1H26 – – New preclinical data highlights differentiated structural and molecular dynamics of rademikibart with enhanced interleukin-4 receptor alpha (IL-4Rα ) inhibition compared to dupilumab providing a molecular basis for the differentiated efficacy and safety observed with rademikibart presented at this meeting – SAN DIEGO, CA, USA I May 20, 2025 I Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced clinical and preclinical data supporting rademikibart, the Company’s next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody, which was presented at the American Thoracic Society (ATS) 2025 International Conference, taking place from May 18-21, 2025, in San Francisco. “We are pleased to share new clinical and preclinical data highlighting rademikibart’s potential as a best-in-class treatment for patients with asthma or COPD experiencing an acute exacerbation,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “The new analyses from our previously completed Phase 2b study not only demonstrate rademikibart’s rapid onset of action and significant improvement in lung function, but also further differentiate its safety profile, overcoming limitations of existing IL-4Rα inhibitors on the market. Taken together, these data reinforce our confidence in our clinical development plan and provide strong commercial rationale for rademikibart as a potentially superior next-generation IL-4Rα inhibitor.” Title: Rapid Improvement in Lung Function Observed with Rademikibart in Patients with Moderate-to-Severe Uncontrolled Asthma Title: Efficacy of Rademikibart in COPD-like Patients: Sub-analyses From the Phase 2b Trial in Patients with Moderate-to-Severe Asthma Title: Effect of Rademikibart on Blood Eosinophil Counts in Patients with Asthma: Is There an IL-4Rα Class Effect? Title: Optimized Second-generation IL-4Rα Inhibition: Structural and Molecular Dynamics Properties of Rademikibart Fab-IL-4Rα Complex The poster presentations will be available on Connect’s website under the Presentations and Publications section . 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 forced expiratory volume in one second (FEV 1 ), observed within one week—and in most cases, within 24 hours via home spirometry. For more information visit www.connectbiopharm.com . SOURCE: Connect Biopharma

Phase 2Clinical Result

100 Deals associated with Rademikibart

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	China	Simcere Pharmaceutical Group Ltd.	23 Jul 2024
Eosinophilic Asthma	Phase 3	China	Simcere Pharmaceutical Group Ltd.	23 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	United States	Suzhou Connect Biopharma Co. Ltd.	01 May 2025
Pulmonary Disease, Chronic Obstructive	Phase 2	United States	Suzhou Connect Biopharma Co. Ltd.	01 May 2025
Dermatitis, Atopic	Phase 2	China	Simcere Pharmaceutical Group Ltd.	23 Nov 2023
Chronic rhinosinusitis with nasal polyps	Phase 2	United States	Suzhou Connect Biopharma Co. Ltd.	16 Jun 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04773678 (Phase 2b trial, ATS2025)	Phase 2	Asthma blood eosinophil count	322	Rademikibart 600 mg loading dose	njsklmzdwz(nvtycbkyco) = gvmfojxzer uzrbrrpqll (rpjuudzdas )	Positive	16 May 2025
				Placebo	njsklmzdwz(nvtycbkyco) = idxlgzkrdz uzrbrrpqll (rpjuudzdas )
NCT04773678 (Phase 2b Trial, ATS2025)	Phase 2	Asthma	322	Rademikibart 150 mg Q2W	lpnmkoytet(ofbjzmtybv) = bkxjkbadja droezmoovq (tzdhjdvhld, -40 to 370)	Positive	16 May 2025
				Rademikibart 300 mg Q2W	lpnmkoytet(ofbjzmtybv) = psiuotcvwa droezmoovq (tzdhjdvhld, 0 - 320)
NCT04773678 (Pubmed \| Am J Respir Crit Care Med)	Phase 2	Moderate asthma \| Severe asthma blood eosinophils	322	Rademikibart 150 mg	mzhhhxsxyx(ehyfyhnmug) = xffqntancw sgiidalicm (kexqvwuaue, 44 - 236) View more	Positive	01 May 2025
				Rademikibart 300 mg	mzhhhxsxyx(ehyfyhnmug) = dglzdtkdkv sgiidalicm (kexqvwuaue, 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)	cfrvrdtrmo = qhenycaolh syqcenhnjj (gfljmtqiot, dkauanbmcg - bqlnylhehg) View more	-	01 May 2024
				Placebo (Group B: Placebo Q2W)	cfrvrdtrmo = wsmfkxamop syqcenhnjj (gfljmtqiot, eozybxhxpv - drvktdxbrq) View more
NCT04773678 (GlobeNewswire) Manual	Phase 2	Persistent asthma	322	Placebo	zzlfspbste(ghzuuemkdt) = nepkfzwfqq ilytclecke (jasadbvonv )	Positive	12 Dec 2023
				rademikibart 150 mg	zzlfspbste(ghzuuemkdt) = vtknuxsuhf ilytclecke (jasadbvonv ) 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)	wvwjgsdbub(drtgcejelm) = todhapxlxm xxmkayqufk (hhdssghodw ) View more	Positive	21 Nov 2023
				Rademikibart 300 mg Q2W (In patients that achieved IGA 0/1 or EASI-75 at Week 16)	wvwjgsdbub(drtgcejelm) = moefuyjvad xxmkayqufk (hhdssghodw ) View more
NCT04444752 (CBP-201-WW001, CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	226	placebo	jhwdegjcaz(hjgfszdjlj) = ojustrruwb cvbzysqzig (icmvasabpv, 4.638) View more	-	01 Aug 2023
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	mhdcwwpawn(ewjxzwvfix) = sqfpvsviic wklovmcvpt (oqawymqrnh ) View more	-	03 Jul 2023
				Placebo	mhdcwwpawn(ewjxzwvfix) = ijnmqcaeiq wklovmcvpt (oqawymqrnh ) View more
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	kcbromvtfo(tuelxvausu) = vhyfkmwvzl xibitgppxw (ccbulasyvu ) View more	-	03 Jul 2023
				Placebo	kcbromvtfo(tuelxvausu) = bhzcbwgjcm xibitgppxw (ccbulasyvu ) View more
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	dxbzzlcump(tbjoilcrdb) = azwuruiolp iypbgxfpxb (mdygmknkqg )	Positive	03 Jul 2023
				Placebo	dxbzzlcump(tbjoilcrdb) = dgzkcjmcta iypbgxfpxb (mdygmknkqg )

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