Abivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s Disease
2024年10月4日 - 5:01AM
Abivax Announces First Patient Enrolled
in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s
Disease
PARIS, France, October 3, 2024 – 10:00
p.m. 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 the first patient was enrolled in its Phase 2b
ENHANCE-CD (NCT06456593) trial evaluating obefazimod in patients
with Crohn’s disease (CD).
The multicenter, double-blind, randomized,
placebo-controlled trial will evaluate the efficacy and safety of
obefazimod, administered once daily, in adults with moderately to
severely active Crohn’s disease.
Fabio Cataldi, MD, Abivax Chief Medical
Officer, said, “The enrollment of the first patient in our
Phase 2b trial marks a significant step forward in meeting the need
for a convenient, oral, once-daily treatment option for people with
moderately to severely active Crohn's disease. This milestone
brings us closer to addressing the unmet needs of patients seeking
effective therapies with fewer burdens on their daily lives."
Trial Design
This trial 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 to
placebo in subjects who are enrolled in the Extension Phase.
*****
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. A Phase 2b clinical trial in Crohn’s disease is ongoing, with
the first patient enrolled in October 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 RelationsAbivax
SApatrick.malloy@abivax.com+1 847 987 4878FORWARD-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
“continue,” “could,” “expect,” “goal,” “intend,” “objective,”
”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, including obefazimod’s potential to provide meaningful
benefit to patients suffering from CD, 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. 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
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
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as giving investment advice. It has no connection with the
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