Antibe Receives Approval to Initiate PK/PD Study of Otenaproxesul

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TORONTO, September 28, 2023--(BUSINESS WIRE)--Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage company leveraging its hydrogen sulfide platform to develop next-generation therapies targeting pain and inflammation, is pleased to announce Health Canada’s approval to initiate the pharmacokinetic/pharmacodynamic ("PK/PD") study of otenaproxesul’s faster-absorbing formulation for acute pain. Set to commence in October, the purpose of the study is to inform the doses for the Phase II trial.

"With this approval, we’re excited to start the first-in-human study of otenaproxesul’s new formulation -- and to be on track to launch the Phase II trial in calendar Q1 2024," commented Dan Legault, Antibe’s CEO. "We look forward to updating our shareholders with the PK/PD results later in the upcoming quarter."

About Antibe Therapeutics Inc.

Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target 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 Information

This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, the anticipated scope, timing, duration and completion of certain of the Company’s clinical trial programs and studies including the PK/PD study and its results, the Phase II trial and the anticipated timing for seeking market approval for certain of the Company’s drugs and therapies for certain additional indications. 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 drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedar.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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Contacts

Antibe Therapeutics Inc.
Christina Cameron
VP Investor Relations
+1 416-577-1443
christina@antibethera.com

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