Abivax Reports Positive Interim Efficacy
and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to
Severe Ulcerative Colitis Patients After 2-Years of Open-Label
Maintenance
- Patients treated
with a de-escalated dose of 25 mg of obefazimod once daily
demonstrated maintenance of clinical remission at weeks 48 and
96
- Efficacy and
safety demonstrated out to six years of treatment
- The treatment
was well-tolerated, with a safety profile consistent with previous
studies and no new safety signals detected
PARIS, France, October 3, 2024, 8:30 a.m.
CEST – Abivax SA (Euronext Paris & 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, announced the results of an
interim efficacy and safety analysis of an open-label maintenance
(OLM) study that enrolled patients with UC at the conclusion of the
Phase 2a and Phase 2b OLM studies, where they had received
obefazimod 50mg once daily. The data demonstrated maintenance of
clinical remission and a safety profile consistent with prior
studies of oral, once-daily obefazimod when administered at a
reduced dose of 25mg for up to an additional two years.
“These important data further support the potential
of obefazimod as a promising therapeutic option for patients with
UC,” said Marla Dubinsky, MD, Co-Director, Susan and
Leonard Feinstein IBD Clinical Center at Icahn School of Medicine
at Mount Sinai New York. “The results observed at a lower
dose are particularly encouraging, as clinicians often like to have
the option to de-escalate dosing once patients achieve
remission”.
In this open-label maintenance study, patients who
had completed the 4-year Phase 2a or 2-year Phase 2b OLM studies,
where they had received 50 mg of once-daily obefazimod, were given
the opportunity to continue receiving obefazimod at a reduced dose
of 25mg daily for up to five additional years (provided they met
the eligibility criteria of Mayo Endoscopic Subscore = 0 or 1). A
total of 130 patients entered the study, as of Sep 11, 2024, the
data cut-off date, 113 have been evaluated out to 48 weeks and 74
have undergone the full 96-week evaluation.
At study baseline, 89% (116/130) of patients were
in clinical remission. At weeks 48 and 96 of treatment, 84%
(95/113) and 87% (64/74) of patients evaluated were in clinical
remission, respectively. Similarly, 92% (119/130) of patients were
in symptomatic remission at study baseline. At weeks 48 and 96, 91%
(103/113) and 92% (68/74) of patients evaluated were in symptomatic
remission, respectively. Similar trends were observed with other
efficacy analyses.
Silvio Danese, MD, Professor of
Gastroenterology at the San Raffaele University, Milan,
Italy, stated “For patients with UC, a significant need
exists for an oral treatment option that is not only well-tolerated
and convenient, but that provides maintenance of remission over a
long period of time. The obefazimod data released today, with
patients maintained for up to 6 years of treatment, provides me
with great hope that we are getting closer to meeting that
significant need.”
The safety results were consistent with previous
studies, with no new safety signals detected. Patient retention
rates were high, with only 12% (16/130) of patients discontinuing
in the first year and 5% (6/114) discontinuing during the second
year of treatment (33 patients have not reached week 96 as of Sept
11, 2024, the data cutoff date.
“The maintenance of clinical remission and the
promising tolerability data observed to date, underscores the
potential of obefazimod as a treatment for ulcerative colitis. We
look forward to presenting this data at an upcoming medical
meeting,” said 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 potentially enhance the expression of a single
microRNA, miR-124. Phase 2 clinical trials in patients with UC have
generated positive data, resulting in the initiation of a pivotal
global Phase 3 clinical trial program (ABTECT Program), with first
patients enrolled in the United States in October 2022. Initiation
of a Phase 2b clinical trial in Crohn’s disease is expected in Q4
2024, and exploration of potential combination therapy
opportunities in UC is ongoing.
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. More information on the Company is
available at www.abivax.com. Follow us on LinkedIn and on X,
formerly Twitter, @Abivax.
Contact:
Patrick MalloySVP, Investor Relations, Abivax
patrick.malloy@abivax.com +1 847 987 4878
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking
statements, forecasts and estimates, including those relating to
the Company’s business and financial objectives. Words such as
“expect,” “plan,” “potential,” “will” and variations of such words
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements include statements
concerning or implying the therapeutic potential of Abivax's drug
candidates, the timing of initiation of clinical trials,
obefazimod’s potential, as monotherapy or in combination with other
therapies, to provide meaningful benefit to patients suffering from
UC, Crohn’s disease, IBD or other indications, 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
our Annual Report on Form 20-F filed with the U.S. Securities and
Exchange Commission on April 5, 2024, 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 labelling and other matters that could affect
the availability or commercial potential of such product
candidates. Current results are not necessarily indicative of
future results. 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 only as of the date of this press release. Readers
are cautioned not to place undue reliance on these forward-looking
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