Abivax Studies Optimistic Interim Efficacy and Security Evaluation of As soon as-Every day 25mg Obefazimod in Average to Extreme Ulcerative Colitis Sufferers After 2-Years of Open-Label Upkeep
- Sufferers handled with a de-escalated dose of 25 mg of obefazimod as soon as every day demonstrated upkeep of scientific remission at weeks 48 and 96
- Efficacy and security demonstrated out to 6 years of therapy
- The therapy was well-tolerated, with a security profile in keeping with earlier research and no new security indicators detected
PARIS, France, October 3, 2024, 8:30 a.m. CEST “ Abivax SA (Euronext Paris & Nasdaq: ABVX) (Abivax or the Firm), a clinical-stage biotechnology firm targeted on growing therapeutics that harness the physique’s pure regulatory mechanisms to stabilize the immune response in sufferers with power inflammatory illnesses, introduced the outcomes of an interim efficacy and security evaluation of an open-label upkeep (OLM) research that enrolled sufferers with UC on the conclusion of the Section 2a and Section 2b OLM research, the place they’d obtained obefazimod 50mg as soon as every day. The information demonstrated upkeep of scientific remission and a security profile in keeping with prior research of oral, once-daily obefazimod when administered at a diminished dose of 25mg for as much as an extra two years.
These necessary information additional help the potential of obefazimod as a promising therapeutic choice for sufferers with UC, stated Marla Dubinsky, MD, Co-Director, Susan and Leonard Feinstein IBD Medical Middle at Icahn Faculty of Medication at Mount Sinai New York. The outcomes noticed at a decrease dose are significantly encouraging, as clinicians typically wish to have the choice to de-escalate dosing as soon as sufferers obtain remission.
On this open-label upkeep research, sufferers who had accomplished the 4-year Section 2a or 2-year Section 2b OLM research, the place they’d obtained 50 mg of once-daily obefazimod, got the chance to proceed receiving obefazimod at a diminished dose of 25mg every day for as much as 5 further years (offered they met the eligibility standards of Mayo Endoscopic Subscore = 0 or 1). A complete of 130 sufferers entered the research, as of Sep 11, 2024, the information deadline, 113 have been evaluated out to 48 weeks and 74 have undergone the total 96-week analysis.
At research baseline, 89% (116/130) of sufferers had been in scientific remission. At weeks 48 and 96 of therapy, 84% (95/113) and 87% (64/74) of sufferers evaluated had been in scientific remission, respectively. Equally, 92% (119/130) of sufferers had been in symptomatic remission at research baseline. At weeks 48 and 96, 91% (103/113) and 92% (68/74) of sufferers evaluated had been in symptomatic remission, respectively. Related traits had been noticed with different efficacy analyses.
Silvio Danese, MD, Professor of Gastroenterology on the San Raffaele College, Milan, Italy, said For sufferers with UC, a big want exists for an oral therapy choice that’s not solely well-tolerated and handy, however that gives upkeep of remission over an extended time period. The obefazimod information launched at present, with sufferers maintained for as much as 6 years of therapy, offers me with nice hope that we’re getting nearer to assembly that important want.
The protection outcomes had been in keeping with earlier research, with no new security indicators detected. Affected person retention charges had been excessive, with solely 12% (16/130) of sufferers discontinuing within the first 12 months and 5% (6/114) discontinuing in the course of the second 12 months of therapy (33 sufferers haven’t reached week 96 as of Sept 11, 2024, the information cutoff date.
The upkeep of scientific remission and the promising tolerability information noticed up to now, underscores the potential of obefazimod as a therapy for ulcerative colitis. We sit up for presenting this information at an upcoming medical assembly, stated Fabio Cataldi, MD, Chief Medical Officer, Abivax.
About Obefazimod
Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to doubtlessly improve the expression of a single microRNA, miR-124. Section 2 scientific trials in sufferers with UC have generated constructive information, ensuing within the initiation of a pivotal international Section 3 scientific trial program (ABTECT Program), with first sufferers enrolled in the US in October 2022. Initiation of a Section 2b scientific trial in Crohn’s illness is predicted in This autumn 2024, and exploration of potential mixture remedy alternatives in UC is ongoing.
About Abivax
Abivax is a clinical-stage biotechnology firm targeted on growing therapeutics that harness the physique’s pure regulatory mechanisms to stabilize the immune response in sufferers with power inflammatory illnesses. Based mostly in France and the US, Abivax’s lead drug candidate, obefazimod (ABX464), is in Section 3 scientific trials for the therapy of reasonably to severely energetic ulcerative colitis. Extra info on the Firm is on the market at www.abivax.com. Comply with us on LinkedIn and on X, previously Twitter, @Abivax.
Contact:
Patrick Malloy
SVP, Investor Relations, Abivax
patrick.malloy@abivax.com
+1 847 987 4878
FORWARD-LOOKING STATEMENTS
This press launch comprises forward-looking statements, forecasts and estimates, together with these regarding the Firm’s enterprise and monetary targets. Phrases corresponding to count on, plan, potential, will and variations of such phrases and comparable expressions are supposed to establish forward-looking statements. These forward-looking statements embrace statements regarding or implying the therapeutic potential of Abivax’s drug candidates, the timing of initiation of scientific trials, obefazimod’s potential, as monotherapy or together with different therapies, to offer significant profit to sufferers affected by UC, Crohn’s illness, IBD or different indications, and different statements that aren’t historic reality. Though Abivax’s administration believes that the expectations mirrored in such forward-looking statements are affordable, traders are cautioned that forward-looking info and statements are topic to numerous dangers, contingencies and uncertainties, a lot of that are tough to foretell and customarily past the management of Abivax, that would trigger precise outcomes and developments to vary materially from these expressed in, or implied or projected by, the forward-looking info and statements. An outline of those dangers, contingencies and uncertainties will be discovered within the paperwork filed by the Firm with the French Autorité des Marchés Financiers pursuant to its authorized obligations together with its common registration doc (Doc d’Enregistrement Universel) and in our Annual Report on Type 20-F filed with the U.S. Securities and Trade Fee on April 5, 2024, below the caption Threat Components. These dangers, contingencies and uncertainties embrace, amongst different issues, the uncertainties inherent in analysis and improvement, future scientific information and evaluation, selections by regulatory authorities, such because the FDA or the EMA, concerning whether or not and when to approve any drug candidate, in addition to their selections concerning labelling and different issues that would have an effect on the provision or industrial potential of such product candidates. Present outcomes aren’t essentially indicative of future outcomes. Particular consideration must be given to the potential hurdles of scientific and pharmaceutical improvement together with additional evaluation by the corporate and regulatory businesses and IRBs/ethics committees following the evaluation of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and scientific information. Moreover, these forward-looking statements, forecasts and estimates are solely as of the date of this press launch. Readers are cautioned to not place undue reliance on these forward-looking statements. Abivax disclaims any obligation to replace these forward-looking statements, forecasts or estimates to mirror any subsequent modifications that the Firm turns into conscious of, besides as required by regulation. Details about pharmaceutical merchandise (together with merchandise at present in improvement) that’s included on this press launch just isn’t supposed to represent an commercial. This press launch is for info functions solely, and the data contained herein doesn’t represent both a proposal to promote, or the solicitation of a proposal to buy or subscribe securities of the Firm in any jurisdiction. Equally, it doesn’t give and shouldn’t be handled as giving funding recommendation. It has no reference to the funding targets, monetary scenario or particular wants of any recipient. It shouldn’t be regarded by recipients as an alternative choice to train of their very own judgment. All opinions expressed herein are topic to alter with out discover. The distribution of this doc could also be restricted by regulation in sure jurisdictions. Individuals into whose possession this doc comes are required to tell themselves about and to look at any such restrictions.
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