Two-Part, Open-Label Study to Evaluate Single Dose Pharmacokinetics of an Obefazimod Minitablet Formulation, Estimate the Relative Bioavailability of the Minitablet Formulation and to Evaluate Minitablet Palatability in Healthy Participants

The sponsor is developing a pediatric minitablet formulation as part of the overall pharmaceutical development strategy. In vitro dissolution and physiological-based bio-pharmaceutics modelling and simulation have been used to guide the development of the mini-tablet formulation to match the PK exposure of the adult capsule formulation. The study aims to investigate the relative bioavailability of the 50mg minitablet compared to the adult obefazimod 50 mg capsule in adult healthy volunteers.

Start Date03 Mar 2026

Sponsor / Collaborator

Abivax SA

[+1]

NCT06456593

/ RecruitingPhase 2

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase.
The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies.
The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.

Start Date30 Oct 2024

Sponsor / Collaborator

Abivax SA

CTIS2024-514561-20-00

/ Not yet recruitingPhase 1

A Phase I study to evaluate the pharmacokinetics, safety and tolerability of multiple oral doses of obefazimod in participants with renal impairment and matched normal kidney function.

Start Date09 Sep 2024

Sponsor / Collaborator

Abivax SA

100 Clinical Results associated with Obefazimod

100 Translational Medicine associated with Obefazimod

100 Patents (Medical) associated with Obefazimod

Literatures (Medical) associated with Obefazimod

01 Dec 2026·CURRENT OPINION IN PHARMACOLOGY

miR-124 upregulation as a new therapeutic strategy: The evolving role of obefazimod in ulcerative colitis

Review

Author: Parra-Izquierdo, Viviana ; Verstockt, Bram ; Solitano, Virginia

Ulcerative colitis (UC) remains difficult to manage, with many patients failing to achieve durable, steroid-free remission despite available biologics and small molecules. Obefazimod (ABX464) is a first-in-class, oral small molecule that enhances microRNA-124 (miR-124) biogenesis, suppressing STAT3 and CCL2 signaling, reducing Th17 polarization and macrophage activation. This inflammation-dependent mechanism enables targeted immune modulation without broad immunosuppression. In Phase IIa and IIb trials, obefazimod significantly improved clinical remission, clinical response, and endoscopic outcomes versus placebo, with durable efficacy maintained in a 96-week maintenance study. The pivotal Phase III ABTECT-1 and ABTECT-2 trials (n = 1275) confirmed these findings, achieving a pooled placebo-adjusted clinical remission rate of 16.4% at week 8 and meeting all key secondary endpoints, with symptomatic improvement reported as early as week 1. Across studies, obefazimod showed a consistent, reassuring safety profile, with most adverse events mild to moderate, low discontinuation rates, and no new safety signals during long-term exposure. Obefazimod represents a promising addition to the therapeutic landscape for moderate-to-severe UC. Key questions remain regarding its optimal positioning, real-world effectiveness, and potential role in rational combination regimens to further improve remission depth and durability.

01 Oct 2026·Clinical Gastroenterology and Hepatology

EFFICACY AND SAFETY OF ADVANCED THERAPIES AS INDUCTION THERAPY FOR ULCERATIVE COLITIS: AN UPDATED SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS

Review

Author: Olivera, Pablo A ; Fumery, Mathurin ; Singh, Siddharth ; Sands, Bruce E ; Danese, Silvio ; Jairath, Vipul ; Lasa, Juan S ; Peyrin-Biroulet, Laurent

BACKGROUND & AIMS:

Advanced therapies (ATs) are central to the management of moderate-to-severe ulcerative colitis (UC). The expanding therapeutic landscape and limited head-to-head trials necessitate updated comparative effectiveness analyses. We performed a systematic review and network meta-analysis (NMA) to assess the efficacy and safety of ATs as induction therapy for UC.

METHODS:

We searched MEDLINE, Embase, and Cochrane CENTRAL. We included phase 3 randomized controlled trials evaluating approved ATs or agents in late-stage development for induction therapy in moderate-to-severe UC. Pairwise meta-analyses and NMA were conducted using a frequentist random-effects model. Confidence was evaluated using the CINeMA framework. The primary outcome was clinical remission; secondary outcomes included endoscopic improvement, serious adverse events (SAEs), adverse events leading to discontinuation (AELDs), and serious infections. Analyses were stratified by prior exposure to ATs.

RESULTS:

Thirty-three induction trials involving 17 therapies, were included. Upadacitinib demonstrated the highest relative efficacy for clinical remission (RR 6.90; 95% CI 3.54-12.45; P-score 0.95; high confidence) and endoscopic improvement (RR 5.29; 95% CI 3.38-8.28; P-score 0.97; moderate confidence). In AT-naïve patients, obefazimod and upadacitinib showed the highest efficacy, whereas in AT-experienced patients, upadacitinib, ustekinumab, and tofacitinib ranked highest. Anti-p19 inhibitors, including risankizumab, subcutaneous guselkumab, and mirikizumab, were associated with the most favorable safety profiles for SAEs and AELDs, although confidence in safety estimates was lower.

CONCLUSIONS:

Upadacitinib has high efficacy for induction of clinical remission and endoscopic improvement in AT-naïve and AT-experienced patients. Novel therapies, like obefazimod and guselkumab subcutaneous, may represent highly effective alternatives. Anti-p19 inhibitors offer a favorable safety profile.

01 Sep 2026·PEDIATRIC DRUGS

Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries

Review

Author: Le, Jessica ; Crowley, Eileen ; Colman, Ruben J ; Ma, Christopher ; Suthar, Nidhi Rashmikant ; Hanzel, Jurij ; Gupte, Dhruv ; Jairath, Vipul ; Cheng, Camilyn ; MacDonald, John K ; Feagan, Brian G

Abstract:

Background and Aims:

Despite considerable advancements in the therapeutic landscape of inflammatory bowel disease (IBD) for adults, long delays exist for paediatric IBD (pIBD) approval, with a median delay of >7 years following adult approval. Our aim is to summarise the landscape of pIBD clinical trials through a review of trial registries.

Methods:

We conducted a cross-sectional review of ClinicalTrials.gov and ClinicalTrialsRegister.eu to identify investigational and approved therapeutic agents for the treatment of pIBD. All interventional studies involving pIBD (aged <18 years) from database inception to July 2, 2026, were considered for inclusion.

Results:

Of 3941 records screened, 123 completed trials (77 randomised controlled trials [RCTs] and 46 non-RCTs) and 90 active trials (55 RCTs and 35 non-RCTs) met the inclusion criteria. A majority of completed trials (71%) recruited mixed adult and paediatric populations, whereas nearly half of the active trials recruited exclusively paediatric patients, with most studies enrolling participants aged 2–17 years. Biologics were assessed in 81 trials (42 completed and 39 active), including the approved agents ( n = 39), infliximab, adalimumab, golimumab, and ustekinumab, and investigational therapies ( n = 42) such as vedolizumab, guselkumab, mirikizumab, risankizumab, duvakitug, afimkibart, and tulisokibart. Nine completed and 11 active trials assess small molecule therapies, including tofacitinib, upadacitinib, filgotinib, etrasimod, ozanimod, and obefazimod.

Conclusions:

Efforts to expedite approval of new agents in pIBD are warranted to ensure timely access to effective medications. Consideration for novel trial designs alongside continued engagement with regulatory bodies, sponsors, and the academic pIBD community is essential to advance drug approvals for pIBD.

148

News (Medical) associated with Obefazimod

08 Oct 2026

·www.biospace.com

Aardvark Therapeutics Appoints Clinical Development Leader David Zhang, Ph.D., MBA, to its Board of Directors

Brings more than 25 years of experience in clinical strategy, biostatistics and regulatory submissions from Abivax, Alumis, MyoKardia and Genentech/Roche SAN DIEGO, Oct. 08, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark or the Company) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced the appointment of David Zhang, Ph.D., MBA, to its Board of Directors, effective October 7, 2026. Dr. Zhang will serve as an independent director. “David has spent more than 25 years designing clinical programs, analyzing pivotal trial data and supporting regulatory submissions, including the Phase 3 study design, readout and New Drug Application for CAMZYOS® (mavacamten) at MyoKardia,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “His experience and strategic perspective will be a valuable addition to our Board at an important time for Aardvark. We are pleased to welcome him.” “Aardvark is at a pivotal moment, with important decisions ahead for ARD-101,” said Dr. Zhang. “I look forward to working with Tien and the Board to help navigate the regulatory landscape and shape the next phase of development for people living with Prader-Willi Syndrome.” Dr. Zhang currently serves as Chief Strategy Officer of Abivax S.A., a clinical-stage biotechnology company focused on therapeutics for chronic inflammatory diseases, where he is a member of the Executive Committee and has overseen biometrics, regulatory affairs, quality assurance and health economics and outcomes research. At Abivax, he led the biometrics team through positive topline readouts of two pivotal Phase 3 trials of obefazimod in ulcerative colitis. From 2021 to 2024, he was Senior Vice President, Biometrics and Data Management at Alumis Inc., where, as a founding executive, he built the biometrics and data management functions, served as interim Chief Information Officer, and helped the company progress through its initial public offering. Previously, Dr. Zhang was Vice President, Head of Biometrics, Data Science and Digital Health at MyoKardia, Inc., where he oversaw the pivotal trial design, readout and NDA submission for CAMZYOS® (mavacamten) for treating obstructive hypertrophic cardiomyopathy prior to the company’s acquisition by Bristol Myers Squibb. Earlier in his career, he held biometrics and strategic innovation leadership roles at Roche Sequencing Solutions and Genentech/Roche over a 15 year period, and statistician roles at Eli Lilly and Company and Abbott Laboratories. Dr. Zhang serves on the board of directors of the Bay Area Biotech-Pharma Statistics Workshop and is a past president of the organization. He holds a Ph.D. in biostatistics from the UCLA Fielding School of Public Health and an executive MBA in finance from the Kelley School of Business at Indiana University, and completed postdoctoral research in statistical genetics at Columbia University. About Aardvark Therapeutics, Inc. Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. For more information, visit Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, the regulatory path forward for ARD-101, including the design of any future Phase 3 study, the anticipated contributions of Dr. Zhang to the Board of Directors and the Company’s programs, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to the FDA clinical hold on ARD-101 and Aardvark’s ongoing engagement with the FDA; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; the risk that Aardvark may use its capital resources sooner than expected; the possibility that the past track records of Aardvark and its personnel may not be repeated or indicative of future success; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 filed with the Securities and Exchange Commission on August 11, 2026. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. Investor and Media Contact Argot Partners (212) 600-1902 Aardvark@Argotpartners.com

Executive ChangeAcquisitionPhase 3

30 Sep 2026

·www.biospace.com

Abivax to Present Data on Obefazimod at United European Gastroenterology (UEG) Week 2026

Abivax to Present Data on Obefazimod at United European Gastroenterology (UEG) Week 2026 Four oral presentations and three posters build upon Phase 3 ABTECT Maintenance and Induction programs in ulcerative colitis, long-term Phase 2 findings, and preclinical anti-fibrotic research PARIS, France – September 30, 2026 – 10:05 PM CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced that seven scientific abstracts on obefazimod, its lead drug candidate for the treatment of moderately to severely active ulcerative colitis (UC), will be presented at the United European Gastroenterology (UEG) Week 2026 meeting, taking place October 17–20, 2026, in Barcelona, Spain. These presentations will highlight data from the Phase 3 ABTECT Maintenance and Induction trials in UC, long-term follow-up from the Phase 2 program in UC, and preclinical research on obefazimod's anti-fibrotic and anti-tumor activity. "The data being presented at UEG Week add to the growing understanding of obefazimod and its potential in inflammatory bowel disease,” said Marc de Garidel, MBA, Chief Executive Officer of Abivax. “These findings reinforce our confidence in obefazimod’s potential to address significant unmet needs for patients living with inflammatory bowel disease." Chris Rabbat, PhD, Chief Medical Officer of Abivax, added, "The seven accepted abstracts reflect the breadth and maturity of the obefazimod program, spanning Phase 3 maintenance results, long-term Phase 2 efficacy and safety data, and preclinical findings on inflammation and fibrosis. We look forward to sharing these findings with the global gastroenterology community and highlighting the growing clinical and scientific evidence supporting obefazimod.” Visit the publications page of Abivax’s website to view the presentations after the conclusion of the meeting. Data to be Presented: Date & Time Session Room Abstract # Title Presenter Oral Presentation October 19, 10:50–11:00 Hot Topics in Clinical GI Research D3 OP097 Efficacy and safety of obefazimod in patients with moderately to severely active ulcerative colitis: results from the Phase 3, randomized, double-blind, placebo-controlled, 44-week maintenance trial (ABTECT-Maintenance) Prof. Bruce E. Sands, MD, MS Professor of Medicine at Icahn School of Medicine at Mount Sinai October 19, 10:50–11:00 Molecular Trajectories of Disease and Drug Responses in IBD A1 OP091 Obefazimod increases miR-124 expression to consistently modulate inflammation and fibrosis across preclinical models Prof. Silvio Danese, MD, PhD Professor of Gastroenterology and Director of Gastroenterology and Gastrointestinal Endoscopy Unit at IRCCS San Raffaele Hospital October 19, 12:00–12:10 Long-term Outcomes of Interventional Trials in IBD A2 OP107 Long-term efficacy and persistence with obefazimod after dose de-escalation to 25 mg: 3-year interim analysis in patients with moderately to severely active ulcerative colitis completing Week 144, stratified by prior advanced therapy experience: results from the Phase 2 program Prof. Bruce E. Sands, MD, MS Professor of Medicine at Icahn School of Medicine at Mount Sinai October 20, 12:20–12:30 Looking into the Future: Novel Therapeutics in IBD, Part 2 B3 OP260 Efficacy of obefazimod in Phase 3 ABTECT-Maintenance trial: results of 44-week therapy in subsets of patients with and without prior inadequate response to advanced therapies Prof. Silvio Danese, MD, PhD Professor of Gastroenterology and Director of Gastroenterology and Gastrointestinal Endoscopy Unit at IRCCS San Raffaele Hospital Moderated Poster October 18, 17:24–17:30 Outcomes from RCT in IBD (II) Hall 7 – Poster Stage 2 MP0294 Efficacy, persistence, and safety of obefazimod in patients with moderately to severely active ulcerative colitis: 3-year interim analysis following dose de-escalation to 25 mg in the open-label maintenance Phase 2 study Bram Verstockt, MD, PhD Associate Professor and Principal Investigator at KU Leuven October 18, 17:36–17:42 Outcomes from RCT in IBD (II) Hall 7 – Poster Stage 2 MP0296 Symptoms of bowel urgency and nocturnal bowel movements are linked with improvement in clinical outcomes among patients with moderately to severely active ulcerative colitis treated with obefazimod: pooled results from the 8-week ABTECT Phase 3 induction trials David T. Rubin, MD Professor of Medicine and Chief, Gastroenterology, Hepatology and Nutrition at The University of Chicago E-Poster October 17, 9:00 – 9:00 IBD, including microscopic colitis Hall 7 PP1180 Obefazimod reduces inflammation-driven tumor burden in a murine model of colitis-associated cancer Prof. Silvio Danese, MD, PhD Professor of Gastroenterology and Director of Gastroenterology and Gastrointestinal Endoscopy Unit at IRCCS San Raffaele Hospital About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. Contact: Patrick Malloy SVP, Investor Relations Abivax SA patrick.malloy@abivax.com +1 847 987 4878 Media Contact: LifeSci Communications Karissa Baltz, PhD Associate Director LSC_ABIVAX@lifescicomms.com FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “on track,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the potential therapeutic benefit of obefazimod and obefazimod’s potential to address significant unmet needs for patients living with inflammatory bowel disease, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission on March 23, 2026, under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions. Attachment 2026_09_30_Abivax to Present Data on Obefazimod at UEG Week 2026

25 Sep 2026

·www.fiercebiotech.com

Travere chief makes way for former Amicus CEO—Chutes & Ladders

Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the industry. Please send the good word—or the bad—from your shop to Donavyn Coffey, Marissa Russo and Will Maddox, and it will be featured here at the end of each week. Travere chief makes way for former Amicus CEO Travere Therapeutics Travere Therapeutics CEO Eric Dube , Ph.D., is stepping down after overseeing the company's launch of the rare kidney disease drug Filspari. On Dec. 1, Bradley Campbell will take the reins after leading Amicus Therapeutics through its recent $4.8 billion acquisition by BioMarin . Dube will stay on as an executive advisor through Feb. 15, 2027, to support the transition. Travere said Dube is leaving to focus on his family. He rebranded the company as Travere to distance it from its original name, Retrophin, which was founded by “pharma bro” Martin Shkreli. In 2023, the company won FDA accelerated approval for its IgA nephropathy medicine Filspari. Campbell arrives with more than 20 years of rare disease experience, joining Amicus in 2006 before succeeding founder and longtime helmsman John Crowley in 2022. During his tenure, Amicus graduated from a single-product company in 2023 after scoring FDA approval for its Pombiliti + Opfolda regimen for Pompe disease. Story Ex-Cue CEO takes the reins at Lift Lift Therapeutics has tapped former Cue Biopharma CEO Daniel Passeri as chief executive as it works to advance its lead immuno-modulatory alpha neutrophil (iMAN) program into human trials in 2027. The London-based biotech is developing a new class of immunotherapy for hard-to-treat cancers. “I am honored to join at this pivotal stage and work closely with Bo [director and president of Lift] to lead the team as we advance our first iMAN therapeutic into the clinic in early 2027 while continuing to build a differentiated portfolio of transformational, allogeneic, neutrophil-based therapies designed to address some of the most challenging tumors,” Passeri said in a release. Passeri joins Lift after a nine-year run as CEO of Cue Biopharma, which focuses on immunological disorders. Before that, he served as president and CEO of oncology biotech Curis. Release Nuclera’s new leader sets sights on growth Protein science biotech Nuclera has brought Carl Raimond on as CEO as the company looks to scale. Co-founder and former CEO Michael Chen , Ph.D., will move into the chief scientific and business officer post. Raimond previously served as president of Olink Proteomics, which he led through its $3 billion acquisition by Thermo Fisher Scientific in 2023. He also held senior leadership posts at Agilent Technologies and Affymetrix. “Now, we’ve reached an important point in the company’s evolution and Carl is the right CEO to lead us forward,” Chen said in a statement. “Carl’s experience building and scaling life-science businesses, combined with his understanding of the opportunity ahead, will be a huge asset to Nuclera.” Raimond said he aims to sharpen the company’s focus on customer adoption, commercial execution and expanding applications of its technology. The Nuclera leadership transition is effective immediately. Release > Amgen-backed cancer immunotherapy company ImmunoScape has named Peter Olagunju as its new CEO. Co-founder Michael Fehlings , Ph.D., continues to lead the company’s scientific and technical strategy as chief technology officer. Release > Roche said its board of directors has approved proposing Christophe Weber , former CEO of Takeda Pharmaceuticals, for election to the board. Release > Rare disease biotech Mirum Pharmaceuticals has appointed Rob Myers , M.D., chief medical officer. Myers joins Mirum from OrsoBio, where he served in the same role and as head of development. Release > French biotech Abivax appointed in-house global medical affairs leader Chris Rabbat , Ph.D., chief medical officer as the company advances toward commercialization of obefazimod for ulcerative colitis. Abivax also added Tim Kelly as chief technical officer. Release > Ona Therapeutics appointed Aleix Prat , M.D., Ph.D., chief medical officer as the biotech advances into the clinic and builds out its antibody-drug conjugate pipeline. Release > Wave Life Sciences reeled in Sanofi, Blackstone and Pfizer alum Monika Vnuk , M.D., as chief business officer to help advance its RNA medicine platforms for obesity, alpha-1 antitrypsin deficiency, liver disease and more. Release > Engitix Therapeutics tapped Sonia Quaratino , M.D., Ph.D., as executive vice president and chief medical officer. Quaratino has been on the Engitix board since 2023 and brings 35 years of experience in oncology, autoimmunity and inflammatory diseases. Release > Basecamp Research named AstraZeneca, Merck and Biogen alum Richard Pearce chief business officer to help expand pharmaceutical partnerships for the AI-designed medicines company. Release

Executive ChangeDrug ApprovalImmunotherapyAcquisition

100 Deals associated with Obefazimod

External Link

KEGG	Wiki	ATC	Drug Bank
D12345	-	-	DB14828

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 3	Argentina	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	Australia	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	Austria	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	Bulgaria	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	Canada	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	Czechia	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	Greece	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	Hungary	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	India	Abivax SA	16 Nov 2022
Colitis, Ulcerative	Phase 3	Netherlands	Abivax SA	16 Nov 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05507203 (ABTECT-1, CTgov)	Phase 3	Colitis, Ulcerative	639	ABX464 (ABX464 50mg)	xujpcqfvvi = zzquzokiqu tzhiilswix (kjnruuawct, vidvsscote - ainnprqrpw) View more	-	10 Sep 2026
				ABX464 (ABX464 25mg)	xujpcqfvvi = pyrsulylfl tzhiilswix (kjnruuawct, nlqpaaftaw - ulluafwnfu) View more
NCT05507216 (ABTECT-2, CTgov)	Phase 3	Colitis, Ulcerative	636	ABX464 (ABX464 50mg)	hdcowzgjiw = bsmnvllqdf xipuxlhudp (rmhgkjqzmn, mjvqanvgua - crmyoywcfo) View more	-	10 Sep 2026
				ABX464 (ABX464 25mg)	hdcowzgjiw = hprdvkczuh xipuxlhudp (rmhgkjqzmn, uozjmgwxrr - nuheikwrce) View more
NCT05507203 \| NCT05507216 (ABTECT-2, Company_Website) Manual	Phase 3	Ulcerative colitis, active moderate \| Ulcerative colitis, active severe	580	Obefazimod 25 mg	viunvhitwf(gsjpnphsbs) = nroebemqdb yuiuxdobnj (itwxhhzlbt ) View more	Positive	01 Jun 2026
				Obefazimod 50 mg	viunvhitwf(gsjpnphsbs) = bbbqkovjkq yuiuxdobnj (itwxhhzlbt ) View more
NCT05507203 (ABTECT-1, DDW2026)	Phase 3	Colitis, Ulcerative	1,272	Obe-50	cxfgttsrec(vydyjdrynm) = zggfzudwrw ndsltiqyyj (pipcgjfpno ) View more	Positive	02 May 2026
				Obe-25	cxfgttsrec(vydyjdrynm) = rnaoqomxri ndsltiqyyj (pipcgjfpno )
NCT05507203 (ABTECT-1, ECCO 12026 \| ECCO 22026)	Phase 3	Ulcerative colitis, active severe	122	Obefazimod 25 mg QD	yrvsghwucm(ycrilfodir) = luhlhztkqf uftkgtlagr (yektashkze ) View more	Positive	18 Feb 2026
				Obefazimod 50 mg QD	ddtvgvrtte(ncmaglltfs) = txwhqfyakr jwmoogudvd (rnwuostztt ) View more
NCT05507203 (ABTECT-1, ECCO2026)	Phase 3	Colitis, Ulcerative	1,272	Obefazimod 50 mg QD	porhumeshs(smdikjdjmv) = unsexnhsah ivevvvqsga (gxyrvejlsa ) View more	Positive	18 Feb 2026
				Obefazimod 25 mg QD	porhumeshs(smdikjdjmv) = roxlxjfecf ivevvvqsga (gxyrvejlsa ) View more
NCT05507203 (ABTECT-1, ECCO2026 \| DDW2026)	Phase 3	Colitis, Ulcerative	1,272	Obefazimod 50 mg	yhrltybrfv(lrdoxrdath) = fhzapgspkx ythvqecewp (oohrlzezpw ) View more	Positive	18 Feb 2026
				Obefazimod 25 mg	yhrltybrfv(lrdoxrdath) = uhbrrimknp ythvqecewp (oohrlzezpw ) View more
NCT05507203 (ABTECT-1, ECCO2026)	Phase 3	Ulcerative colitis, active severe	1,080	Obefazimod 50 mg QD	mfgzkmzccf(nbnjsnvjsc) = srphxdlvln rsrysrbuqu (tklndeqjbb )	Positive	18 Feb 2026
				Obefazimod 25 mg QD	huwcelcfcw(nbfuetymbw) = qdhpxmpjqv eppnfxzstm (fnobqekqed )
NCT05507203 (ABTECT-1, ECCO2026)	Phase 3	Colitis, Ulcerative	1,272	Obefazimod 50 mg QD	xkkutxheer(fgmnjmyrvx) = snwsschwjf gddtcalkgl (ovdxzsmnff ) View more	Positive	18 Feb 2026
				Obefazimod 25 mg QD	xkkutxheer(fgmnjmyrvx) = rzofxfvurd gddtcalkgl (ovdxzsmnff ) View more
NCT05507203 (ABTECT-1, ECCO2026)	Phase 3	Colitis, Ulcerative	1,272	Obefazimod 50 mg QD	lekmtjdfpa(tjwwfbdfiu) = At baseline, pts reported 6.1, 6.2, and 6.1 days/week with BU in the Obe-50, Obe-25, and PBO groups, respectively. At baseline, pts reported 5.0, 5.2, and 5.0 nights/week of NBM in the Obe-50, Obe-25, and PBO groups, respectively. jdcweyjuiw (rhlnthjcgk ) View more	Positive	18 Feb 2026
				Obefazimod 25 mg QD

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