Antibe Initiates First Clinical Study of Otenaproxesul’s New Formulation

Rhea-AI Summary

Antibe Therapeutics initiates PK/PD study for otenaproxesul's faster-absorbing formulation for acute pain

Positive

• The initiation of the PK/PD study will inform the doses and confirm safety for the Phase II trial
• The Phase II trial is on track to launch in calendar Q1 2024
• The study data expected in November will also advance Antibe's exploration of potential treatment regimens for chronic pain

Negative

• None.

- Data in November will inform Phase II trial expected to launch next quarter

TORONTO--(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 the initiation of the pharmacokinetic/pharmacodynamic (“PK/PD”) study of otenaproxesul’s faster-absorbing formulation for acute pain. The study is designed to inform the doses and confirm safety in preparation for the Phase II trial, on track to launch in calendar Q1 2024.

The PK/PD study will involve 36 healthy volunteers randomized across three treatment arms: a single high dose and two five-day regimens of otenaproxesul. Subjects will remain in-clinic for the duration of their treatment. Expected in November, the study data will also advance Antibe’s exploration of potential treatment regimens for chronic pain.

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 pre-clinical and 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231018902636/en/

Antibe Therapeutics Inc.

Christina Cameron

VP Investor Relations

+1 416-577-1443

christina@antibethera.com

Source: Antibe Therapeutics Inc.

FAQ

What is Antibe Therapeutics working on?

Antibe Therapeutics is developing next-generation therapies targeting pain and inflammation using its hydrogen sulfide platform

What is the purpose of the PK/PD study?

The PK/PD study is designed to inform the doses and confirm safety for the Phase II trial of otenaproxesul's faster-absorbing formulation for acute pain

When is the Phase II trial expected to launch?

The Phase II trial is on track to launch in calendar Q1 2024

What will the study data in November advance?

The study data in November will advance Antibe's exploration of potential treatment regimens for chronic pain