19:17:06 EDT Sat 04 May 2024
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Antibe Therapeutics Inc (2)
Symbol ATE
Shares Issued 52,981,030
Close 2024-03-28 C$ 0.45
Market Cap C$ 23,841,464
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Antibe's otenaproxesul placed on clinical hold by FDA

2024-04-01 09:42 ET - News Release

Ms. Christina Cameron reports

ANTIBE ANNOUNCES FDA CLINICAL HOLD ON OTENAPROXESUL AND LEGAL ACTION BY NUANCE

Antibe Therapeutics Inc. received verbal notice on the afternoon of March 28, 2024, from the United States Food and Drug Administration (FDA) that otenaproxesul has been placed on clinical hold, postponing the initiation of the planned phase 2 trial. Antibe expects to receive a formal clinical hold letter from the FDA within 30 days outlining its rationale and further details.

Separately, Nuance Pharma Ltd. 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 dated 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 co-ordinate operational and governance matters, the company's board of directors is forming an executive committee comprising: Robert E. Hoffman, chair of the board; Dan Legault, chief executive officer; 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 sulphide 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 non-steroidal 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.

We seek Safe Harbor.

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