Abivax Reviews Constructive Interim Efficacy and Security Evaluation of As soon as-Day by day 25mg Obefazimod in Reasonable 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 each day demonstrated upkeep of medical remission at weeks 48 and 96Efficacy and security demonstrated out to 6 years of therapy The therapy was well-tolerated, with a security profile per 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 continual inflammatory illnesses, introduced the outcomes of an interim efficacy and security evaluation of an open-label upkeep (OLM) examine that enrolled sufferers with UC on the conclusion of the Part 2a and Part 2b OLM research, the place they’d obtained obefazimod 50mg as soon as each day. The information demonstrated upkeep of medical remission and a security profile per prior research of oral, once-daily obefazimod when administered at a decreased dose of 25mg for as much as an extra two years.
These essential knowledge additional assist the potential of obefazimod as a promising therapeutic possibility 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 notably encouraging, as clinicians usually wish to have the choice to de-escalate dosing as soon as sufferers obtain remission.
On this open-label upkeep examine, sufferers who had accomplished the 4-year Part 2a or 2-year Part 2b OLM research, the place they’d obtained 50 mg of once-daily obefazimod, got the chance to proceed receiving obefazimod at a decreased dose of 25mg each day for as much as 5 further years (supplied they met the eligibility standards of Mayo Endoscopic Subscore = 0 or 1). A complete of 130 sufferers entered the examine, as of Sep 11, 2024, the information deadline, 113 have been evaluated out to 48 weeks and 74 have undergone the complete 96-week analysis.
At examine baseline, 89% (116/130) of sufferers had been in medical remission. At weeks 48 and 96 of therapy, 84% (95/113) and 87% (64/74) of sufferers evaluated had been in medical remission, respectively. Equally, 92% (119/130) of sufferers had been in symptomatic remission at examine baseline. At weeks 48 and 96, 91% (103/113) and 92% (68/74) of sufferers evaluated had been in symptomatic remission, respectively. Comparable tendencies had been noticed with different efficacy analyses.
Silvio Danese, MD, Professor of Gastroenterology on the San Raffaele College, Milan, Italy, acknowledged For sufferers with UC, a big want exists for an oral therapy possibility that isn’t solely well-tolerated and handy, however that gives upkeep of remission over an extended time period. The obefazimod knowledge launched at present, with sufferers maintained for as much as 6 years of therapy, gives me with nice hope that we’re getting nearer to assembly that vital want.
The protection outcomes had been per 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 yr and 5% (6/114) discontinuing through the second yr of therapy (33 sufferers haven’t reached week 96 as of Sept 11, 2024, the information cutoff date.
The upkeep of medical remission and the promising tolerability knowledge noticed thus far, underscores the potential of obefazimod as a therapy for ulcerative colitis. We sit up for presenting this knowledge 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. Part 2 medical trials in sufferers with UC have generated optimistic knowledge, ensuing within the initiation of a pivotal international Part 3 medical trial program (ABTECT Program), with first sufferers enrolled in the US in October 2022. Initiation of a Part 2b medical trial in Crohn’s illness is predicted in This fall 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 continual inflammatory illnesses. Based mostly in France and the US, Abivax’s lead drug candidate, obefazimod (ABX464), is in Part 3 medical trials for the therapy of reasonably to severely lively ulcerative colitis. Extra info on the Firm is out there at www.abivax.com. Observe us on LinkedIn and on X, previously Twitter, @Abivax.
Contact:
Patrick MalloySVP, 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 goals. Phrases akin to anticipate, plan, potential, will and variations of such phrases and comparable expressions are meant 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 medical trials, obefazimod’s potential, as monotherapy or together with different therapies, to supply 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 cheap, traders are cautioned that forward-looking info and statements are topic to numerous dangers, contingencies and uncertainties, lots 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 Change Fee on April 5, 2024, beneath the caption Threat Components. These dangers, contingencies and uncertainties embrace, amongst different issues, the uncertainties inherent in analysis and growth, future medical knowledge and evaluation, selections by regulatory authorities, such because the FDA or the EMA, relating to whether or not and when to approve any drug candidate, in addition to their selections relating to labelling and different issues that would have an effect on the provision or business potential of such product candidates. Present outcomes will not be essentially indicative of future outcomes. Particular consideration must be given to the potential hurdles of medical and pharmaceutical growth together with additional evaluation by the corporate and regulatory companies and IRBs/ethics committees following the evaluation of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and medical knowledge. 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 replicate any subsequent adjustments that the Firm turns into conscious of, besides as required by regulation. Details about pharmaceutical merchandise (together with merchandise presently in growth) that’s included on this press launch just isn’t meant to represent an commercial. This press launch is for info functions solely, and the data contained herein doesn’t represent both a suggestion to promote, or the solicitation of a suggestion 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 goals, monetary scenario or particular wants of any recipient. It shouldn’t be regarded by recipients as an alternative to train of their very own judgment. All opinions expressed herein are topic to vary 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 watch any such restrictions.
Supply: Abivax
