Abivax Completes Dosing in Phase 2a Proof-of-Concept Clinical Trial of ABX464 in Ulcerative Colitis (ABX464-101)

PARIS–()–Regulatory News:

ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a
biotechnology company harnessing the immune system to develop a
functional cure for HIV, as well as treatments for
inflammatory/autoimmune diseases and cancer, today announced the
completion of dosing in its Phase 2a clinical trial ABX464-101 in 32
patients with moderate-to-severe ulcerative colitis (UC). Patients will
be monitored and data collected and analyzed by investigators according
to trial protocol. Top-line results are expected in September of 2018.

“Because of its mechanism, which has demonstrated powerful
anti-inflammatory properties, ABX464 may have the potential to bring
significant clinical benefit to patients struggling with inflammatory
bowel diseases like UC so we are eager to see the top-line data from
this study and continue development,”
said Prof. Dr. Hartmut
Ehrlich, M.D., Chief Executive Officer at ABIVAX
. “We’re on track
to report top-line results from this trial inSeptember of 2018 and, if
positive, move ABX464 rapidly into a Phase 2b clinical trial.”

ABX464-101 is a randomized, double-blind, placebo-controlled Phase 2a
proof-of-concept study evaluating the safety and efficacy of ABX464 50mg
given once daily versus placebo for two months in subjects with
moderate-to-severe active ulcerative colitis who have failed or are
intolerant to immunomodulators, anti-TNFα, vedolizumab and/or
corticosteroids. This clinical study is being conducted in 17 centers in
seven European countries: Belgium, France, Germany, Austria, Hungary,
Poland and Czech Republic. As of today, all of the 32 recruited
patients, randomized 2:1 to receive ABX464 or placebo, have completed
the study and will undergo a one-month follow-up period. The study
employs state-of-the art technologies for monitoring potential treatment
effects, including numerical recording of the colonoscopies with
centralized reading.

Prof. Dr. Severine Vermeire, M.D., Head of the IBD center at the
University Hospitals Leuven, Belgium and Principal Investigator of the
study, said: “Even with the introduction of biologic treatments in
recent years, there is still a largely unmet need as too many patients
never respond or stop responding to biologics. It is encouraging that
the majority of patients in the trial (21/32) agreed to enroll into the
one year open-label extension study with ABX464, ABX464-102, which will
provide us with important long-term safety and maintenance efficacy

ABX464-102 is a 12-month open-label follow-up study for patients who
complete ABX464-101.

About ABX464
The rationale for the ABX464-101 study was
based on preclinical data demonstrating that ABX464 had a strong
anti-inflammatory effect. In macrophages, this effect was shown to be
mediated by a 50-fold increase of IL-22 expression , a cytokine known as
a potent suppressor of inflammatory processes, and a ten-fold increase
of miR124 in peripheral blood mononuclear cells (PBMCs). mIR124 is a
micro-RNA with potent anti-inflammatory properties and has recently been
described as a tumor suppressor gene.

Inflammation is a cornerstone of IBD, particularly in ulcerative colitis
and Crohn’s disease. When evaluated in a mouse model of IBD, ABX464
demonstrated a long-lasting effect in preventing the typical symptoms of
inflammatory colitis, including histological changes1.

About Ulcerative Colitis
Ulcerative colitis is a
debilitating inflammatory bowel disease in adults and children, with
limited therapeutic management options for many patients. It is
estimated that close to 1 million patients with ulcerative colitis live
in the United States, and global pharmaceutical sales for this disease
are estimated to be around $5.7 billion in 2017.

About ABIVAX (www.abivax.com)
is mobilizing the body’s natural immune machinery to treat patients with
viral infections, autoimmune diseases and cancer. A clinical-stage
company, ABIVAX leverages its antiviral and immune enhancing platforms
to optimize candidates to cure HIV and treat inflammatory bowel
diseases, as well as liver cancer. ABIVAX is listed on Euronext
compartment B (ISIN: FR0012333284 – Mnémo: ABVX). More information on
the company is available at www.abivax.com/en.
Follow us on Twitter @ABIVAX_

1 K Chebli et al., The Anti-HIV Candidate ABX464 Dampens
Intestinal Inflammation by Triggering Il-22 Production in Activated
Macrophages. Nature Scientific Reports 2017,

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