Abivax Provides Operational and Key Program
Update
- Phase 3 ABTECT Trial evaluating
obefazimod in moderately to severely active ulcerative colitis (UC)
on track to complete enrollment in early Q1 2025
- Top-line results from the ABTECT
8-week induction trial expected early Q2 2025, with 44-week
maintenance data on pace to read out in Q1 2026; timing assumptions
for New Drug Application (NDA) submission remain unchanged
- Continued progress on pre-clinical
combination therapy program
- Sylvie Grégoire named Chair of
Abivax’s Board of Directors; Dr. Fabio Cataldi named Chief Medical
Officer and Dr. David Zhang named Chief Strategy Officer
- Cash position allows for runway
into Q4 2025 through ABTECT 8-week induction top-line results
PARIS, France, July 15, 2024, 10:00 p.m.
CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX)
(“Abivax”, “we” 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 provided an
update on the progress of key clinical and preclinical programs and
its leadership and operational updates.
Marc de Garidel, Chief Executive Officer
(CEO) of Abivax: “During the first half of 2024, the
Abivax team made significant progress with our Phase 3 ABTECT
program, and we are on pace to complete enrollment for the Phase 3
ABTECT program in early Q1 2025, followed by the read-out of the
top-line results of the 8-week induction trial in early Q2 2025,
and the top-line results from the long-term maintenance trial
evaluating patients treated at 52 weeks in Q1
2026.”
Mr. de Garidel continued, “As
previously announced, based on its early clinical profile, the
formal process evaluating combination therapy of oral and
injectable candidates with obefazimod in UC began in January. Over
the past six months, the company has initiated the preclinical
evaluation of combination therapies in mouse models. We have
generated exciting preliminary data that we plan to communicate at
an upcoming scientific congress.”
Abivax also announces the election of Sylvie
Grégoire as the new Chair of the Abivax Board of Directors, taking
over for current CEO and Interim Chair, Marc de Garidel. With Ms.
Grégoire joining the Board of Directors, Carol Brosgart, MD will be
resigning from the Abivax Board.
Mr. de Garidel said “On behalf
of the Abivax Board of Directors, I would like to warmly welcome
Sylvie
to the team. With more than three decades of successful operational
and leadership experience, Sylvie will serve Abivax well as we
enter a critical time in our company’s evolution.” Mr. de Garidel
went on to say “We thank Carol Brosgart for the significant
contributions that she brought to Abivax over the past several
years.”
Ms. Grégoire said “I am
enthusiastic to join Abivax as the new Chair of the Board of
Directors at such an exciting time, and I look forward to working
with the team to realize the potential of obefazimod.”
Didier Blondel, Chief Financial Officer
(CFO): “We continue into the second half of 2024 with a
cash runway to take the Company through critical milestones that
will advance our pivotal Phase 3 ABTECT program for obefazimod in
moderate-to-severe ulcerative colitis.” Mr. Blondel continued, “We
will continue to focus on careful expense management and thoughtful
capital allocation to support execution of the ABTECT Program”.
Operating highlights and ongoing
clinical trials
ABTECT Obefazimod Phase 3 Program in
UC
ABTECT is a randomized, double-blinded
placebo-controlled trial evaluating the efficacy and safety of 50mg
and 25mg doses of obefazimod administered once daily (QD) compared
to placebo. In patients with moderately to severely active UC, the
trial is enrolling 1,200 subjects across 36 countries at 600 trial
sites and consists of an 8-week induction trial followed by a
44-week maintenance trial (for a total of 52 weeks of
treatment).
Anticipated milestones:
- Early Q1 2025:
Anticipated enrollment completion of ABTECT program
- Early Q2 2025:
Expected top-line induction data read-out after eight weeks of
treatment
- Q1 2026:
Planned top-line maintenance results after one year of
treatment
With the milestone of 600 active trial sites in
36 countries achieved recently, and with close to 50% of patients
currently enrolled, the obefazimod Phase 3 ABTECT program
investigating efficacy and safety in adults with moderately to
severely active UC is actively recruiting in all regions with an
accelerated pace and is expected to reach full enrollment in early
Q1 2025, with top-line results anticipated in early Q2 2025.
Based on these timelines, assuming favorable
results from the ABTECT trial program, the Company anticipates
being in position to submit an NDA to the FDA in late H1 2026,
seeking approval of obefazimod for the treatment of moderately to
severely active UC.
Obefazimod 25 mg long-term extension
trial in UC
The obefazimod 25mg long-term extension trial is
an open-label trial evaluating the long-term safety and efficacy of
25mg of obefazimod given once a day (QD) in subjects who have been
previously enrolled in the Phase 2a and Phase 2b trials who were
previously treated with 50mg of obefazimod (OLE and maintenance
trials) and who are willing to continue their treatment.
Anticipated milestone:
- Q3 2024:
Anticipated trial data read-out after one and two years of
continued treatment with a reduced dose of obefazimod at 25 mg
In an interim analysis as of July 31, 2023, of
the 71 eligible patients, 63 completed their 48-week visit, 84% (53
of 63 patients) achieved disease control defined as stable or
improved Modified Mayo Score on 25mg once-daily obefazimod. No new
safety signals were detected in UC patients treated up to five
years with oral, once daily obefazimod.
Planned clinical trials
ENHANCE-CD: Obefazimod Phase 2b trial in
Crohn’s disease (CD)
ENHANCE-CD is a Phase 2b, multicenter,
double-blind, placebo-controlled trial that will evaluate the
efficacy, safety, pharmacokinetics, and pharmacodynamics of
obefazimod in subjects with moderately to severely active CD. The
trial design consists of a 12-week induction period and a
subsequent 40-week maintenance period.
Anticipated milestones:
- September 2024: ENHANCE-CD planned
start of patient enrollment
- 2H 2026: ENHANCE-CD planned 12-week
induction data read-out
In alignment with FDA feedback on the Company’s
initial Phase 2a IND application submission early 2024, the CD
trial design was adapted to be a dose-ranging Phase 2b clinical
trial. These adjustments to the obefazimod CD clinical program are
not expected to have an impact on the overall program budget and
projected supplemental New Drug Application (sNDA) submission
timeline.
R&D progress
Anticipated milestones:
- 2H 2024:
Disclosure of preclinical data of obefazimod combination therapy
for the treatment of moderately to severely active UC
- 2H 2024:
Selection of first obefazimod follow-on drug candidate from
Abivax’s miR-124 library
Obefazimod in combination
therapy: As previously announced, based on its early
clinical profile, the formal process evaluating combination therapy
of oral and injectable candidates with obefazimod in UC began in
January 2024. Over the past six months, the Company has initiated
the preclinical evaluation of combination therapies in mouse
models. The Company has generated exciting preliminary data that
will be submitted for presentation at an upcoming scientific
congress. Additional preclinical combination studies are
ongoing.
Obefazimod follow-on candidate selection
from miR-124 library: R&D work on potential follow-on
drug candidates to be selected from Abivax’s compound library is
ongoing. Selection of the first follow-on drug candidate is
expected before the end of 2024 to further strengthen the Abivax
pipeline.
Financial update
Based upon the strong dynamics of its current
R&D portfolio with obefazimod in UC in Phase 3 trials, in CD in
Phase 2b trial and in UC for potential combination therapy, as well
as with the final research work to bring a follow-on compound of
obefazimod into development before 2024 year-end, the Company has
decided to further focus its planned resources toward R&D,
while gating commercial spends until after the UC Phase 3 induction
readout, and carrying on streamlining G&A expenses.
From a financial standpoint, on June 21, 2024,
the Company drew down the €25m remaining tranche (Tranche C) under
the Kreos and Claret debt agreements signed in August 2023.
With €222m cash and cash equivalent in hand as
of June 30, 2024, cash position allows for runway into Q4 2025
through ABTECT 8-week induction top-line results milestone in early
Q2 2025, with a potential opportunity to extend into Q1 2026,
should the Company decide to draw the remaining tranche (Tranche B)
pursuant to the Heights Capital convertible bonds agreement signed
in August 2023.
Leadership and organizational
updates
Abivax announces the appointment of Dr. Sylvie
Grégoire as Chair of the Board of Directors effective immediately.
Dr. Grégoire is a distinguished pharmaceutical and biotech
executive with over 30 years in international leadership roles. Her
expertise encompasses late-stage development, financial raises and
commercial expansion. Dr. Grégoire is the Co-Founder and was
Executive Chair of the Board at EIP Pharma Inc., based in Boston,
MA. Under her leadership, EIP Pharma transitioned into CervoMed, a
publicly listed company on NASDAQ (CRVO), developing the first
disease-modifying treatment for Dementia with Lewy Bodies. Dr.
Grégoire has previously served on the board of Cubist, Glycofi,
Vifor Pharma, Revvity and chaired the board of IDM Pharma, Corvidia
and CervoMed. Dr. Grégoire is currently a member of the board of
Novo Nordisk, CervoMed and F2G Ltd.
Dr. Carol Brosgart has announced her resignation
from the board. Dr. Brosgart joined the Abivax board in 2018 and we
thank her for her significant contributions to the evolution and
progress of the Company.
As Abivax enters into the final stages of the
ABTECT program and prepares to commence the Phase 2b ENHANCE-CD
trial, we are pleased to announce the appointment of Dr. Fabio
Cataldi as Chief Medical Officer. Dr. Cataldi joins Abivax with
more than 20 years of successful experience in the development and
commercialization of innovative therapies. He brings deep clinical,
medical and scientific knowledge and expertise in immunology and
gastroenterology, having served in senior research and development
roles at Arena Pharmaceuticals, AbbVie, Shire, Pfizer, Biogen and
Novartis. Most recently he held the role of CMO at Landos BioPharma
until the successful sale to AbbVie. Dr. Cataldi will have internal
responsibility for Clinical Operations, Clinical Development,
Pharmacovigilance and Medical Affairs.
Additionally, David Zhang, Ph.D will join Abivax
as Chief Strategy Officer. Dr. Zhang joins Abivax from Alumis,
where he held the role of Chief Information Officer responsible for
building up capabilities in Biometrics, IT, Facilities and Investor
Relations during the early days of the company. Before Alumis, Dr.
Zhang held the role of Vice President of Biometrics and Digital
Health at Myokardia where he played a pivotal role in the study
design, data read-out, and New Drug Application submission for
Camyzos. Dr. Zhang will have internal responsibility for
Biometrics, Quality, HEOR and Regulatory.
The Company also announces Dr. Sheldon Sloan,
MD, M Bioethics will be leaving his role as Chief Medical Officer.
After 37 years of clinical medicine and various roles in the
Pharmaceutical Industry, Dr. Sloan has decided to retire. We deeply
appreciate all his contributions to Abivax and to the ABTECT
program which include recruiting and building the medical team
functions of Pharmacovigilance, Clinical Development, Clinical
Pharmacology, Biometrics and Medical Affairs. The Company also
announces that Chief Commercial Officer Michael Ferguson has left
the organization to pursue other opportunities.
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 X (former Twitter).
Contact:
Patrick MalloySVP, Investor Relations Abivax
patrick.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
“design,” “expect,” “forward,” “future,” “potential,” “plan,”
“project” 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 the availability of data as well as
timing of enrollment and reporting results from its clinical
trials, including its Phase 3 ABTECT induction trial, obefazimod
extension trials in UC, and obefazimod Phase 2b trial in CD, 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
selection of an obefazimod follow-on drug candidate from Abivax’s
miR-124 library, the timing of NDA and sNDA submissions,
obefazimod’s potential to provide meaningful benefit to patients
suffering from UC, CD, IBD or other indications, and enrollment of
patients in clinical trials, Abivax’s cash runway and strategy to
extend its cash runway, 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 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
judgment. All opinions expressed herein are subject to change
without notice. The distribution of this document may be restricted
by law in certain jurisdictions. Persons into whose possession this
document comes are required to inform themselves about and to
observe any such restrictions.
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