Abivax Announces ABTECT Phase 3 Trial Achieves Key Enrollment Milestone
06 Agosto 2024 - 1:30AM
Abivax Announces ABTECT Phase 3 Trial
Achieves Key Enrollment Milestone
- Phase 3 ABTECT Trial evaluating obefazimod in moderately to
severely active ulcerative colitis (UC) surpassed the 600-patient
enrollment milestone confirming ABTECT currently on pace to reach
full enrollment in early Q1 2025
- To date, baseline participants baseline characteristics and
trial trends in line with observations from Phase 2b trial
PARIS, France, August 6, 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 today that in July 2024,
the 600th participant was enrolled in the Phase 3 ABTECT Trial.
Based on this milestone and current enrollment pace, the Company
reaffirms expectations to reach full enrollment in early Q1 2025.
An updated version of the Company’s corporate presentation
reflecting these updates can be found on its website at
www.abivax.com.
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 Q3
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 X (former
Twitter).Contact
Patrick MalloySVP, Investor
RelationsAbivaxpatrick.malloy@abivax.com+1 847 987 4878 |
or |
Abivax Communicationscommunications@abivax.com |
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,” “potential” 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,
Abivax’s expectations regarding timing of enrollment for its Phase
3 ABTECT induction trial, 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
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
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
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Abivax (EU:ABVX)
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