A PHASE II MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGE FINDING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ALX-0061 ADMINISTERED SUBCUTANEOUSLY IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Start Date01 Jan 2016

Sponsor / Collaborator-

NCT02518620

/ CompletedPhase 2

A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061

This was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously (s.c.) in subjects with active rheumatoid arthritis (RA) who had completed the treatment and assessment period of one of the preceding Phase IIb studies with ALX-0061 (ALX0061-C201 and ALX0061-C202; placebo and ALX-0061 treatment arms only), and who achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) (66/68 counts) compared to Baseline at the final visit of the preceding study (i.e., Week 24 for Study ALX0061-C201 and Week 12 for Study ALX0061-C202).

Start Date01 Jul 2015

Sponsor / Collaborator

Ablynx NV

NCT02437890

/ CompletedPhase 2

A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

Primary objective:
To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo.
Secondary objectives:
To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.

Start Date01 Jul 2015

Sponsor / Collaborator

Ablynx NV

100 Clinical Results associated with Vobarilizumab

100 Translational Medicine associated with Vobarilizumab

100 Patents (Medical) associated with Vobarilizumab

Literatures (Medical) associated with Vobarilizumab

01 Jun 2020·Annals of the rheumatic diseasesQ1 · MEDICINE

Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis

Q1 · MEDICINE

Review

Author: van Vollenhoven, Ronald ; McInnes, Iain B ; Kerschbaumer, Andreas ; Sepriano, Alexandre ; Smolen, Josef S ; Burmester, Gerd R ; Falzon, Louise ; Landewé, Robert ; Bijlsma, Johannes W J ; de Wit, Maarten ; van der Heijde, Désirée ; Dougados, Maxime

Objectives:

To inform the 2019 update of the European League against Rheumatism (EULAR) recommendations for the management of rheumatoid arthritis (RA).

Methods:

A systematic literature research (SLR) to investigate the efficacy of any disease-modifying antirheumatic drug (DMARD) (conventional synthetic (cs)DMARD, biological (b) and biosimilar DMARD, targeted synthetic (ts)DMARD) or glucocorticoid (GC) therapy in patients with RA was done by searching MEDLINE, Embase and the Cochrane Library for articles published between 2016 and 8 March 2019.

Results:

234 abstracts were selected for detailed assessment, with 136 finally included. They comprised the efficacy of bDMARDs versus placebo or other bDMARDs, efficacy of Janus kinase (JAK) inhibitors (JAKi) across different patient populations and head-to-head of different bDMARDs versus JAKi or other bDMARDs. Switching of bDMARDs to other bDMARDs or tsDMARDs, strategic trials and tapering studies of bDMARDs, csDMARDs and JAKi were assessed. The drugs evaluated included abatacept, adalimumab, ABT-122, baricitinib, certolizumab pegol, SBI-087, CNTO6785, decernotinib, etanercept, filgotinib, golimumab, GCs, GS-9876, guselkumab, hydroxychloroquine, infliximab, leflunomide, mavrilimumab, methotrexate, olokizumab, otilimab, peficitinib, rituximab, sarilumab, salazopyrine, secukinumab, sirukumab, tacrolimus, tocilizumab, tofacitinib, tregalizumab, upadacitinib, ustekinumab and vobarilizumab. The efficacy of many bDMARDs and tsDMARDs was shown. Switching to another tumour necrosis factor inhibitor (TNFi) or non-TNFi bDMARDs after TNFi treatment failure is efficacious. Tapering of DMARDs is possible in patients achieving long-standing stringent clinical remission; in patients with residual disease activity (including patients in LDA) the risk of flares is increased during the tapering. Biosimilars are non-inferior to their reference products.

Conclusion:

This SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR’s RA management recommendation.

01 Dec 2019·Journal of ophthalmic inflammation and infection

Interleukin-6 inhibition in the management of non-infectious uveitis and beyond

Review

Author: Vigil, Erin ; Nguyen, Nam V ; Hassan, Muhammad ; Karkhur, Samendra ; Plaza, Carlos ; Do, Diana V ; Sepah, Yasir J ; Tran, Anh T ; Afridi, Rubbia ; Halim, Muhammad Sohail ; Nguyen, Quan Dong ; Hasanreisoglu, Murat

Abstract:

Background:

Uveitis consists of a spectrum of inflammatory disorders characterized by ocular inflammation. The underlying pathophysiology consists of a complex interplay of various inflammatory pathways. Interleukin 6 is an important mediator of inflammation in uveitis and constitutes focus of research toward development of newer biological therapies in the management of non-infectious uveitis.

Main body:

Pan-blockade of the inflammatory pathways with steroids is generally the first step in the management of acute non-infectious uveitis. However, long-term therapy with steroids is associated with systemic and ocular side effects, thereby necessitating the need for development of steroid sparing agents. IL-6 is a cytokine produced by various immune cells, in response to molecular patterns and affects multiple inflammatory cells. In particular, IL-6 is involved in differentiation of CD-4 cells into Th-17 cells that have been shown to play a significant role in various immune-mediated diseases such as uveitis. This broad-spectrum immunomodulatory activity makes IL-6 an excellent target for immunomodulatory therapy. Tocilizumab was the first IL-6 inhibitor to demonstrate efficacy in humans. It inhibits IL-6 from binding to both membrane-bound and soluble receptor and can be administered via intravenous (IV) and subcutaneous (SC) routes. It has been FDA approved for treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA). Following the approval in systemic diseases, its efficacy was demonstrated in various uveitis studies including a phase 2 clinical trial (STOP-Uveitis). Overall, tocilizumab has shown a good safety profile with the risk of malignancy consistent with that expected in patients with rheumatoid arthritis. However, tocilizumab therapy has been shown to increase the risk for gastrointestinal perforation and dose-dependent neutropenia. Following the success of tocilizumab, several other agents targeting the IL-6 pathway are in the pipeline. These include sirukumab, siltuximab, olokizumab, clazakizumab, and EBI-031 which target IL-6; Sarilumab and ALX-0061 act on the IL-6 receptor.

Conclusion:

Studies have shown that IL-6 inhibitors can be effective in the management of NIU. In addition, the levels of IL-6 are elevated in other ocular vascular diseases such as retinal vein occlusion and diabetic macular edema. The roles of IL-6 inhibition may be broadened in the future to include the management of retinal vascular diseases and non-uveitic macular edema.

01 May 2015·Archives of pharmacal researchQ3 · MEDICINE

IL-6 inhibitors for treatment of rheumatoid arthritis: past, present, and future

Q3 · MEDICINE

Review

Author: Jong Min Lee ; Yu Mi Lee ; Go Woon Kim ; Sung Hyun Chung ; Hye Seung Jeong ; Ryo Han Pi ; Na Ra Lee ; Yee Seul Lim

Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by polyarthritis. Numerous agents with varying mechanisms are used in the treatment of RA, including non-steroidal anti-inflammatory drugs, disease-modifying anti-rheumatic drugs, and some biological agents. Studies to uncover the cause of RA have recently ended up scrutinizing the importance of pro-inflammatory cytokine such as tumor necrosis factor α (TNF-α) and interleukin (IL)-6 in the pathogenesis of RA. TNF-α inhibitors are increasingly used to treat RA patients who are non-responsive to conventional anti-arthritis drugs. Despite its effectiveness in a large patient population, up to two thirds of RA patients are found to be partially responsive to anti-TNF therapy. Therefore, agents targeting IL-6 such as tocilizumab (TCZ) attracted significant attention as a promising agent in RA treatment. In this article, we review the mechanism of anti-IL-6 in the treatment of RA, provide the key efficacy and safety data from clinical trials of approved anti-IL-6, TCZ, as well as six candidate IL-6 blockers including sarilumab, ALX-0061, sirukumab, MEDI5117, clazakizumab, and olokizumab, and their future perspectives in the treatment of RA.

News (Medical) associated with Vobarilizumab

02 Jul 2024

·www.biospace.com

Scinai Publishes Q1 2024 Financial Results and Provides Business Update

JERUSALEM, July 2, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices business unit, today published its financial results for the quarter ended March 31, 2024, and provided a business update. Business Update & Recent Highlights Financing In support of the Company's strategic pivot, on January 3, 2024, we raised $1.69 million in gross proceeds from the exercise of certain of our outstanding warrants and the issuance of new warrants. H.C. Wainwright & Co. acted as exclusive placement agent in connection with the offering. Nasdaq Compliance and Conversion of EIB Loan into Equity On June 7, 2024 the Company announced that on June 5, 2024, it received formal notification from the Listing Qualification Department (the "Staff") of the Nasdaq Stock Market ("Nasdaq") that the Company had regained compliance with the minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the "Rule"). In the notification provided by the Staff on June 5, 2024, the Staff stated that the Company remains non-compliant with the equity requirement in Listing Rule 5550(b)(1), or any of the alternative requirements under Listing Rule 5550(b), and accordingly the Company presented its plan to get back into compliance with the equity requirement with the Nasdaq Hearing Panel on June 18, 2024. The Plan presented to the panel included a debt-to-equity loan restructuring deal the Company is working on with its lender, the European Investment Bank (the "EIB"). On June 13, 2024 the Company announced that it received a letter of Intent from the EIB. This LoI outlined specific indicative terms for converting the EIB's loan into equity. The Company expects to receive a binding term sheet in July and have the financial contract with EIB fully amended by the end of August. Based on the above plan, the Company requested from the Nasdaq Hearing Panel an extension of the deadline for regaining compliance with the equity requirement. The Company expects to receive the decision of the Hearing Panel in the coming weeks. CDMO business unit In the first six months of 2024 we received CDMO work orders valued at approximately $500K, and we are in advanced contract discussions with several other potential clients. We maintain confidence in our sales guidance for 2024 of $1.25 million in expected revenues. As our CDMO unit is new and we are in a rapid growth stage, acquiring new clients and building our reputation and brand awareness of our CDMO services, we expect revenues from the CDMO business to increase materially in the coming years. This is also coupled with growing demand for boutique CDMO services from early-stage biotech companies looking for fast project onset at competitive pricing without compromising on meeting the most stringent scientific and quality standards. In addition, in 2024 we have been pursuing extensive targeted marketing activities, including online advertisements, direct outreach campaigns and participation in major pharmaceutical conferences, such as BIO Europe Spring in Barcelona (March 2024), and the BioMed Israel conference in Tel Aviv, Israel (May 2024), at which we marketed our CDMO services and met potential partners for our R&D pipeline and potential investors. Our CDMO unit is currently focused both on executing drug development projects for our clients and on validating our processes and facilities to be ready for cGMP inspection by the Israeli Ministry of Health. In June, we held a first of its kind, hands on aseptic processing course at our facility in Jerusalem in collaboration with key figures in the industry including Ms. Rachel Shimonovitz, Head of GMP inspectorate of the Israeli Ministry of Health, and ADRES Int'l Biotech, a leading Israeli regulatory and quality consulting services firm. The course attracted many senior role holders from the Israeli biotech industry who came to our facility for this two-day education and training course. Pipeline Development We are aggressively advancing the NanoAb preclinical development. At the end of April 2024, we concluded an in-vivo proof of concept animal study in collaboration with Prof. Amos Gilhar, a world-renowned dermatologist of the prestigious Technion Israel Institute of Technology. The results look promising and corroborate our aspiration for the development of a novel, local biologics therapeutic for the treatment of patients suffering from plaque psoriasis. On June 4, 2024, we met for a scientific advisory meeting with the Paul Erlich Institute (the PEI) of Germany, the scientific advice of which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S. We expect their final minutes of the meeting in the coming couple of weeks. Upon guidance from the PEI, we expect to commence preparations for a pre-clinical toxicology study before commencing a first-in-human clinical trial of our anti-IL NanoAbs for the treatment of plaque psoriasis in 2025. Additional NanoAbs for treatment of additional autoimmune diseases, such as asthma, atopic dermatitis and wet AMD, have been discovered and characterized at Max Planck and University Medical Center Göttingen as part of their research collaboration agreement with Scinai. Scinai holds exclusive options for exclusive licenses at pre-agreed financial terms for each of the resulting NanoAbs. We are pursuing a strategic partnership for both our COVID-19 self-administered inhaled NanoAb, which demonstrated highly promising in vivo results in animals as both a therapeutic and prophylactic treatment, and our anti-IL-17 nanoAb for the treatment of plaque psoriasis and other potential indications. Q1 2024 Financial Summary R&D expenses for the three months ended March 31, 2024, amounted to $1,568 thousands, compared to $1,995 thousands for the three months ended March 31, 2023. The decrease was primarily due to a reduction in salaries and reduced use of subcontractors. Marketing, general and administrative expenses for the three months ended March 31, 2024, amounted to $484 thousands, compared to $1,191 thousands for the three months ended March 31, 2023. The decrease was primarily due to a reduction in each of salaries, share-based compensation and professional services. Financial income for the three months ended March 31, 2024, amounted to $231 thousands compared to $329 thousands for the three months ended March 31, 2023. Net loss for the three months ended March 31, 2024, was $2,159 thousands compared to net loss of $3,515 thousands for the three months ended March 31, 2023. As of March 31, 2024, Scinai had cash and cash equivalents and short-term deposits of $4,826 thousands compared to $4,870 thousands as of March 31, 2023. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects. Company website: . Company Contacts Investor Relations | +972 8 930 2529 | ir@scinai.com Business Development | +972 8 930 2529 | bd@scinai.com Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Examples of such statements include, but are not limited to, execution of a binding term sheet providing for revised terms of the Finance Contract with EIB, the accounting impact of execution of such revised terms and the ability of the Company to regain and remain compliant with the continued listing standards of Nasdaq, the potential of Scinai's NanoAb program, expected revenues of Scinai's CDMO business and timing of pre-clinical and clinical studies of the Company's anti-IL NanoAbs for the treatment of plaque psoriasis and their results. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to, the risk that the Company will not execute a binding term sheet with the EIB providing for revised terms of the Finance Contract with EIB and the risk that execution of such binding term sheet will not resolve the deficiency notice of Nasdaq with respect to the Company's shareholders' equity; the risk that the Company will otherwise be unable to regain compliance and remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2024 and thereafter, failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other NanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the financial facility under its finance contract with Scinai; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 15, 2024, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Logo - Company Codes: NASDAQ-NMS:SCNI

Financial StatementLicense out/in

29 Aug 2019

·www.biospace.com

AstraZeneca Looks to Challenge GSK in SLE Following Phase III Success

The TULIP 2 trial was the second Phase III trial that assessed the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE. AstraZeneca is aiming to be the second company over the past 60 years to garner a win for a new treatment for patients with systemic lupus erythematosus (SLE). This morning, the U.K.-based company announced that its Phase III TULIP 2 trial assessing anifrolumab for the treatment of SLE hit the mark. The experimental drug met its primary endpoint of achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo. The reduction in disease activity was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) after 52 weeks of use. The BICLA measurement requires improvement in all organs with disease activity at baseline with no new disease flares. The TULIP 2 trial was the second Phase III trial that assessed the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE. AstraZeneca said the BICLA response in the latest trial was consistent with a pre-specified analysis of the previous Phase III TULIP 1 trial , which did not meet its primary endpoint of SLE Responder Index 4. AstraZeneca’s anifrolumab is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon receptor, blocking the activity of all type I interferons including IFN-alpha, IFN-beta and IFN-omega. Between 60% and 80% of adults with SLE have an increased type I interferon gene signature, which has been shown to correlate with disease activity, the company said. “Systemic lupus erythematosus is a debilitating autoimmune disease, but only one new treatment has been approved in the last 60 years. These are important results and we will now review the full data set and explore pathways to bring this potential new treatment to patients,” Mene Pangalos, head of biopharmaceutical R&D at AstraZeneca said in a statement. Systemic lupus erythematosus, the most common form of lupus, is an autoimmune disorder that triggers inflammation in different tissues of the body. SLE causes the immune system attacks its own tissues and causes widespread inflammation and tissue damage in the affected areas, according to the U.S. Centers for Disease Control and Prevention. Approximately five million people suffer from a form of SLE. About 90 percent of diagnosed patients are women. There has been only one new medicine approved for SLE in the last 60 years, GlaxoSmithKline’s Benlysta, which was approved by the FDA in 2016. Benlysta picked up another approval earlier this year for pediatric patients with lupus. AstraZeneca and other companies have been racing to match GSK in providing new treatment options for SLE. Last year, Eli Lilly and Incyte Corporation picked up Fast Track designation from the FDA for their SLE drug, baricitinib . Lilly is currently studying two doses of baricitinib in Phase III SLE trials. Also last year, Nektar Therapeutics launched a Phase Ib study of its asset NKTR-358 in SLE. France-based Ablynx had a significant setback last year with a mid-stage failure of its SLE treatment, vobarilizumab. Full data from both the TULIP 1 and TULIP 2 trials will be presented at a medical conference. In addition, the TULIP program includes a Phase III long-term extension trial in SLE and a Phase II trial in lupus nephritis, the company said.

Phase 3Clinical ResultPhase 2Fast TrackDrug Approval

26 Mar 2018

·www.biospace.com

Ablynx Drug Fails Again in Mid-Stage Trial

For the second time Ablynx’s anti-IL-6R Nanobody, vobarilizumab has failed to pass muster. This morning Belgium-based company said vobarilizumab did not meet primary endpoints in a Phase II dosing study for lupus patients. For the second time Ablynx ’s anti-IL-6R Nanobody, vobarilizumab has failed to pass muster. This morning Belgium-based company said vobarilizumab did not meet primary endpoints in a Phase II dosing study for lupus patients. The primary endpoint of the mid-stage study was the percentage of subjects who achieved a dose-response at Week 24. Ablynx said there was no dose-response reported in patients after the 24 week period, according to a modified BILAG-based combined lupus assessment (mBICLA). The 312 patient trial tested four dose regimens of vobarilizumab plus one placebo dose in patients with moderate to severe, active seropositive systemic lupus erythematosus (SLE). Systemic lupus erythematosus, the most common form of lupus, is an autoimmune disorder that triggers inflammation in different tissues of the body. SLE causes the immune system attacks its own tissues and causes widespread inflammation and tissue damage in the affected areas, according to the U.S. Centers for Disease Control and Prevention. Approximately five million people suffer from a form of SLE. About 90 percent of diagnosed patients are women. In its announcement the company did not present full data regarding the failure, but it noted that demographics and baseline characteristics were similar across all treatment arms and were reflective of a typical SLE population. Ablynx did note that there were adverse events reported in 12.4 percent of all patients treated with vobarilizumab, including two deaths. That was in comparison to 6.5 percent treatment-emergent adverse events in the placebo group. Vobarilizumab targets the interleukin 6 pathway via its IL-6 receptor (IL-6R). IL-6 is a pro-inflammatory cytokine that plays a role in T-cell activation, production of acute phase proteins in response to inflammation, induction of immunoglobulin production, and stimulation of osteoclast differentiation and activation. “We are disappointed that vobarilizumab didn’t show a dose-response in the analysis of the study’s primary endpoint, however, vobarilizumab was well tolerated in all tested dose groups, confirming its favorable safety profile. We will continue to analyze the full data set and thank the study participants and their families as well as the investigators and staff who contributed to this study,” Robert K. Zeldin, chief medical officer at Ablynx, said in a statement. In 2016 vobarilizumab failed to meet endpoints in a Phase IIb trial for rheumatoid arthritis. That failure prompted AbbVie to terminate a 2013 agreement that gave it developmental and commercial options for the drug in RA. However, under the initial agreement, AbbVie also has rights to vobarilizumab as an SLE treatment. In its announcement today Ablynx said AbbVie will review the Phase II lupus data to determine whether or not to exercise its option to license vobarilizumab. “Should AbbVie exercise the option, it would trigger a payment to Ablynx. If the option is not exercised, Ablynx’s agreement with AbbVie would terminate,” the company said. The news of the vobarilizumab failure in lupus comes two months after Ablynx agreed to be acquired by Sanofi in a deal worth $4.8 billion. Sanofi’s key interest was Ablynx’s lead compound caplacizumab (anti-vWF Nanobody), which is being developed as a treatment for acquired thrombotic thrombocytopenic purpura (aTTP).

Phase 2AcquisitionLicense out/inClinical Trial Failure

100 Deals associated with Vobarilizumab

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KEGG	Wiki	ATC	Drug Bank
D11005	Vobarilizumab	-	DB14891

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 2	United States	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Argentina	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Chile	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Czechia	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Germany	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Hungary	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Mexico	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Peru	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Philippines	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	Poland	Ablynx NV	01 Jul 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02287922 (CTgov)	Phase 2	Rheumatoid Arthritis	251	Placebo+ALX-0061 (ALX-0061 150 mg q4w)	tuybzejvdd = qdimulpfkz gvtgzureou (auuriqapcx, quqknkzmhz - yurghbpyit) View more	-	21 Aug 2019
				Placebo+ALX-0061 (ALX-0061 150 mg q2w)	tuybzejvdd = skemxylhxw gvtgzureou (auuriqapcx, zddlpkgvyg - belocjtdpy) View more
NCT02309359 (CTgov)	Phase 2	Rheumatoid Arthritis	345	Placebo+ALX-0061+Methotrexate (ALX-0061 75 mg q4w + MTX)	obmratdgqx = yfratsisnq wsypaskzli (rhwkwnizvk, lauvkeolnq - unmultetka) View more	-	21 Aug 2019
				Placebo+ALX-0061+Methotrexate (ALX-0061 150 mg q4w + MTX)	obmratdgqx = ceubxqeoee wsypaskzli (rhwkwnizvk, miwshlkkys - qhkukxlnwr) View more
NCT02518620 (CTgov)	Phase 2	Rheumatoid Arthritis	406	ALX-0061+MTX (ALX-0061 150 mg q2w + MTX (C201 All Subjects))	lfflecitji = cvwuejomyf nvrjutrblq (snudxeogsp, wnpfbnbuqp - chfdyclonh) View more	-	19 Jul 2019
				ALX-0061 (ALX-0061 150 mg q2w (C202 All Subjects))	lfflecitji = zkuuahkagp nvrjutrblq (snudxeogsp, tofbgzxich - ffenzhqxji) View more
NCT02437890 (CTgov)	Phase 2	Systemic Lupus Erythematosus	312	Placebo (Placebo)	eehqacmrwf = ypozflcufr pbqwrwwktf (kaapucurwg, nimjpdvpry - rahqpwmhaz) View more	-	06 Feb 2019
				Placebo+ALX-0061 (ALX-0061 75 mg q4w)	eehqacmrwf = irmhjuqacp pbqwrwwktf (kaapucurwg, vesgacedop - inczffirys) View more
NCT02437890 (PipelineReview) Manual	Phase 2	Systemic Lupus Erythematosus	312	vobarilizumab	cbocxftypd(urvymjmoto) = did not meet the primary endpoint of dose response based on the modified BILAG-based combined lupus assessment (mBICLA) at Week 24. jvkkiewqqh (wgsunwtgdj )	Negative	26 Mar 2018
				Placebo
EULAR2017	Phase 2	Rheumatoid Arthritis	251	Vobarilizumab 150mg q4w	tqoidvcpfb(vkqduivxpb) = fdxgpsikfl rizmewbsva (davkbkizpm ) View more	Positive	14 Jun 2017
				Vobarilizumab 150mg q2w	tqoidvcpfb(vkqduivxpb) = gnnirhkdqs rizmewbsva (davkbkizpm ) View more
EULAR2017	Phase 2	Rheumatoid Arthritis	345	Vobarilizumab 75mg q4w	uwyhwfxbyn(fvbtwiemox) = ripjmhxxuq xzyogvecie (mxtyiayvul ) View more	-	14 Jun 2017
				Vobarilizumab 150mg q4w	uwyhwfxbyn(fvbtwiemox) = uslzubzejy xzyogvecie (mxtyiayvul ) View more
ACR2014	Not Applicable	-	-	ALX-0061	fhrzyadpou(wfhrnwvuyw) = lkuvmonjjg mnkmlhyscm (mcwopyeofp, 3.6) View more	-	14 Nov 2014
				Tocilizumab (TCZ)	fhrzyadpou(wfhrnwvuyw) = klgxwpdrnw mnkmlhyscm (mcwopyeofp, 16) View more

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis