Abivax Provides Update on Ulcerative
Colitis (UC) Combination Therapy Program Strategy
and Announces Early Preclinical Combination
Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease
(IBD) Mouse Model
- Abivax is actively conducting
preclinical studies with multiple oral and injectable therapies and
will report additional data in Q4 2024.
- Pre-clinical
evaluation of obefazimod combined with etrasimod improved body
weight protection and Disease Activity Index with a synergistic and
statistically significant reduction of several cytokines
(TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each
treatment alone.
PARIS, France, September 25, 2024, 10:00
p.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 results of
initial preclinical combination data of obefazimod combined with
etrasimod in a mouse model of IBD.
“Despite progress and development of multiple
new advanced targeted therapies in IBD, efficacy rates appear to
have reached a ceiling. Fewer than half of patients achieve
clinical remission, and many of those lose response over time. It
is imperative for our field to explore rational and scientifically
driven combination therapies to break through the efficacy ceiling,
which in turn will lead to improved long-term outcomes for
patients,” said David Rubin, MD Professor of Medicine and
Chief, Gastroenterology, Hepatology and Nutrition at The University
of Chicago.
“Our goal for this program is to develop a
fixed-dose combination therapy for UC patients that delivers
best-in-disease state induction and maintenance efficacy, a safety
profile on par with obefazimod, and an IP runway into the late
2040’s”, said Marc de Garidel, CEO of Abivax. He
went on to say, “We believe that obefazimod's emerging safety and
efficacy profile, with potentially best-in-disease maintenance
efficacy, could provide a meaningful benefit to patients when taken
as a monotherapy. Additionally, since obefazimod is an oral therapy
that has thus far demonstrated a favorable safety profile, it is an
attractive candidate to be combined with other mechanisms of action
to attempt to break through the efficacy ceiling observed with
advanced therapies."
Fabio Cataldi, MD Chief Medical Officer
of Abivax provided key elements of the combination therapy
program. “This program involves multiple stages. First, we will
perform additional pre-clinical experiments evaluating the efficacy
of obefazimod in combination with several other mechanisms of
action. Based on our findings, we plan to select a candidate in
2025 and work towards developing a fixed dose combination to move
into clinical development.”
“We are setting a high bar for success and are
excited about the promising data we are generating with this
preclinical combination program,” Mr. de Garidel
said. “We are planning to present this data at an upcoming
scientific conference and are actively conducting additional
combination studies that address various disease pathways. We look
forward to providing an update on our progress by year end.”
Pre-Clinical Program and Initial
Findings
Preclinical evaluation of obefazimod combined
with etrasimod, was conducted in the T-cell adoptive transfer mouse
model. In this study, CD4+CD45high or CD4+CD45low cells were
intraperitoneally injected to 6-week-old male
C57BL/6NRj-Rag2tm1Ciphe/Rj mice (10 mice per group). The mice were
then orally treated for 55 days with obefazimod or etrasimod alone
or with the combination of both compounds. The results showed that
treatment with the combination improved the response on body weight
protection and Disease Activity Index with a synergistic and
statistically significant reduction of several cytokines
(TNF-alpha, IL-17, IL-6, IFN-gamma) in the blood compared to each
drug alone.
About ObefazimodObefazimod,
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 AbivaxAbivax 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 availability and timing of preclinical data to
support decision-making on therapy candidates for use in
combination with obefazimod in UC, as well as the availability and
timing of disclosure of preclinical data of any such combination
therapy, 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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