Antibe Announces FDA Clinical Hold on Otenaproxesul and Legal Action by Nuance
01 April 2024 - 1:00PM
Business Wire
Antibe Therapeutics Inc. (“Antibe” or the “Company” TSX: ATE,
OTCQX: ATBPF) today announced that it received verbal notice on the
afternoon of March 28, 2024 from the U.S. Food and Drug
Administration (“FDA”) that otenaproxesul has been placed on
clinical hold, postponing the initiation of the planned Phase II
trial. Antibe expects to receive a formal Clinical Hold Letter from
the FDA within 30 days outlining their rationale and further
details.
Separately, the Company announced that Nuance Pharma Limited has
commenced legal action in the Ontario Superior Court of Justice to
seek recognition of and enforce the arbitration award in Ontario
previously announced by Antibe in its press release of March 4,
2024. Nuance Pharma is seeking the appointment of a receiver as
part of its relief; a hearing date has not been set.
In light of these developments and to better coordinate
operational and governance matters, the Company's Board of
Directors is forming an Executive Committee composed of Robert E.
Hoffman, Chair of the Board; Dan Legault, CEO; and Yung Wu, Member
of the Board.
Antibe will promptly inform the market when any additional
material information is available.
About Antibe Therapeutics Inc.
Antibe is a clinical-stage biotechnology company leveraging its
proprietary hydrogen sulfide platform to develop next-generation
therapies to target pain and inflammation arising from a wide range
of medical conditions. The Company’s current pipeline includes
assets that seek to overcome the gastrointestinal ulcers and
bleeding associated with nonsteroidal anti-inflammatory drugs
(“NSAIDs”). Antibe’s lead drug, otenaproxesul, is in clinical
development as a safer alternative to opioids and today’s NSAIDs
for acute pain. Antibe’s second pipeline drug, ATB-352, is being
developed for a specialized pain indication. The Company’s next
target is inflammatory bowel disease (“IBD”), a condition long in
need of safer, more effective therapies. Learn more at
antibethera.com.
Forward Looking Statements
This news release includes certain forward-looking statements
under applicable securities laws, which may include, but are not
limited to, statements concerning the anticipated scope, timing,
duration and completion of certain of the Company’s pre-clinical
and clinical trial programs and studies including the Phase II
trial’s timeline for initiation and completion and the anticipated
timing for seeking market approval for certain of the Company’s
drugs and therapies for certain additional indications, and Nuance
Pharma’s seeking recognition of the arbitration award in Ontario.
Any statements contained herein that are not statements of
historical facts may be deemed to be forward-looking, including
those identified by the expressions “will”, “anticipate”,
“believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and
similar wording. Forward-looking statements involve known and
unknown risks and uncertainties that could cause actual results,
performance, or achievements to differ materially from those
expressed or implied in this news release. Factors that could cause
actual results to differ materially from those anticipated in this
news release include, but are not limited to, the Company’s
inability to timely execute on its business strategy and timely and
successfully complete its clinical trials and studies, the
Company’s inability to obtain the necessary regulatory approvals
related to its activities, risks associated with its debt to Nuance
Pharma and Nuance Pharma’s move to recognize the arbitral award in
Ontario, risks associated with drug development generally and those
risk factors set forth in the Company’s public filings made in
Canada and available on sedarplus.com. The Company assumes no
obligation to update the forward-looking statements or to update
the reasons why actual results could differ from those reflected in
the forward-looking statements except as required by applicable
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20240401046957/en/
Antibe Therapeutics Inc. Christina Cameron VP Investor Relations
+1 416-577-1443 christina@antibethera.com
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