Antibe Provides April 2023 Corporate Update

By: Antibe Therapeutics Inc. via Business Wire

April 11, 2023 at 07:00 AM EDT

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies to target inflammation, is pleased to provide a corporate update.

CRO Selected for PK/PD Study for Otenaproxesul’s New Formulation

Further to Antibe’s update of February 15, 2023, the Company has now selected a clinical research organization (“CRO”) to carry out the pharmacokinetic/pharmacodynamic (“PK/PD”) study for otenaproxesul’s new formulation. The purpose of the PK/PD study is to confirm the optimal dosing regimens for the Phase II bunionectomy trial, slated to initiate in calendar Q4 2023 as previously announced.

DILIsym Modeling for Otenaproxesul Expands to Chronic Pain Treatment Regimens

With the positive results attained in modeling otenaproxesul’s liver safety in acute pain treatment regimens, the Company has now embarked on a DILIsym program to explore potential chronic treatment regimens. While this initiative is preliminary, the learning already achieved with DILIsym in combination with the positive animal results for otenaproxesul’s new formulation provide the basis for this investigation. DILIsym is a sophisticated software model widely used to predict liver safety.

Strategic Positioning Assessment for Otenaproxesul Completed

Antibe has concluded a comprehensive strategic positioning assessment of otenaproxesul for acute pain in the U.S. market. The assessment identified a compelling commercial strategy and validated the drug’s best-in-class positioning in a market with few novel therapies in development. In addition, new opportunities for competitive differentiation were identified and are being pursued. The assessment was conducted by a leading life science-focused marketing and commercialization agency.

Continued Progress in Emerging Discovery Program

As noted in its February update, the Company has selected lead and back-up candidates for its inflammatory bowel disease (“IBD”) program. These candidates are being evaluated in animal efficacy models with a patent application filing expected in the current quarter. Separately, Antibe is investigating a family of anti-inflammatory compounds that recently demonstrated promising results in an initial animal model; the Company expects to be in a position to make a more comprehensive announcement in the upcoming quarter.

Nuance Pharma Dispute Proceeds to Arbitration

Further to the disclosure provided in the Company’s most recent Annual Information Form (“AIF”), the dispute with Nuance Pharma has not yet been settled.¹ Accordingly, the parties will be commencing arbitration proceedings in early May under the rules of the Singapore International Arbitration Centre. The Company continues to consider Nuance’s claims to be without merit and will provide updates concerning significant developments as they occur.

About 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 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 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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¹ See page 38 of Antibe’s fiscal 2022 AIF on SEDAR or at antibethera.com/wp-content/uploads/2022/07/ATE-2022-Annual-Information-Form.pdf.