Antibe Provides Development Update for Otenaproxesul

By: Antibe Therapeutics Inc. via Business Wire

October 12, 2022 at 07:00 AM EDT

- Patent application filed for improved formulation; strengthens IP protection to 2042

- Anticipated benefits include faster onset of action, lower doses

- Phase II molar study no longer required; Phase II bunionectomy study on track for H1 2023

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies that target inflammation, is pleased to announce a major advance in otenaproxesul’s formulation that promises to increase its therapeutic benefit and commercial potential. Accordingly, the Company has filed a patent application that strengthens the drug’s IP protection to 2042.

“Since our decision to leverage otenaproxesul’s potency, gastrointestinal protection and overall safety profile for acute pain use, we’ve been working to optimize its pharmacology for this setting,” commented Dan Legault, Antibe’s CEO. “Over the summer, we made significant advances with a faster-dissolving formulation that we’ve been investigating since late last year. With the confidence gained from our recent data and yesterday’s patent application, we are delighted to announce our transition to the new formulation. Beyond unlocking value for our shareholders, we can save resources and streamline our clinical path by bypassing the Phase II molar extraction study originally planned for the fall. Instead, we can capture the necessary data via a set of lower cost, de-risking animal studies, followed by an enhanced Phase II bunionectomy study to begin in the first half of next year – as planned. We’re excited to advance our well-characterized drug in a formulation that promises to make it even better.”

The new formulation’s benefits include: (i) rapid dissolution mechanics, accelerating otenaproxesul’s onset of action, a key benchmark for acute pain medications; and (ii) enhanced bioavailability, enabling a significant dose reduction compared to its current formulation. The lower dose provides an additional safety buffer as well as a potential pathway to address chronic pain indications. The new formulation was developed in collaboration with Antibe’s global manufacturing partner; all related IP is owned exclusively by Antibe.

Antibe Therapeutics Inc.

Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation safer 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 (“GI”) 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 anticipated 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 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 compete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug and medical device 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.