- 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 otenaproxesulโs formulation that promises to increase its therapeutic benefit and commercial potential. Accordingly, the Company has filed a patent application that strengthens the drugโs IP protection to 2042.
โSince our decision to leverage otenaproxesulโs potency, gastrointestinal protection and overall safety profile for acute pain use, weโve been working to optimize its pharmacology for this setting,โ commented Dan Legault, Antibeโs CEO. โOver the summer, we made significant advances with a faster-dissolving formulation that weโve been investigating since late last year. With the confidence gained from our recent data and yesterdayโs 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 โ as planned. Weโre excited to advance our well-characterized drug in a formulation that promises to make it even better.โ
The new formulationโs benefits include: (i) rapid dissolution mechanics, accelerating otenaproxesulโs 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 Antibeโs 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 Companyโs current pipeline includes assets that seek to overcome the gastrointestinal (โGIโ) ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (โNSAIDsโ). Antibeโs lead drug, otenaproxesul, is in clinical development as a safer alternative to opioids and todayโs NSAIDs for acute pain. Antibeโs second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Companyโs anticipated next target is inflammatory bowel disease (โIBDโ), 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 Companyโs clinical trial programs and studies and the anticipated timing for seeking market approval for certain of the Companyโs 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 โwillโ, โanticipateโ, โbelieveโ, โplanโ, โestimateโ, โexpectโ, โintendโ, โproposeโ 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 Companyโs inability to timely execute on its business strategy and timely and successfully compete its clinical trials and studies, the Companyโs 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 Companyโs 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
