08:26 AM EDT, 04/01/2024 (MT Newswires) -- Antibe Therapeutics Inc. ( ATBPF ) , which gained more than 4.5% last Thursday, on Monday announced that it received verbal notice from the U.S. Food and Drug Administration on March 28 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.

Otenaproxesul is Antibe's lead drug and is in clinical development as a safer alternative to opioids and NSAIDs for acute pain.

Antibe also reported that Nuance Pharma has begun legal action in the Ontario Superior Court of Justice to enforce the arbitration award in Ontario previously announced by Antibe in its March 4 press release. The Singapore International Arbitration Centre ordered Antibe to refund US$20 million and costs of US$4 million, to Nuance. The licence agreement for the commercialization of otenaproxesul in the greater China region was also rescinded. Nuance Pharma is seeking the appointment of a receiver as part of its relief. A hearing date has not been set.

Antibe said "in light of these developments and to better coordinate operational and governance matters", it is forming an Executive Committee composed of Robert E. Hoffman, Chair of the Board; Dan Legault, CEO; and Yung Wu, Board Member.