TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. (TSXV: ATE, OTCQB: ATBPF) today provides an update on the timing of top-line results for the Phase 2B dose-ranging, efficacy study for its lead drug, ATB-346. Involving 360 patients across 40 clinical sites, this study is one of the largest ever undertaken in Canada. The Company is pleased to report that its clinical research organization (“CRO”), Veristat, was able to complete the trial and capture all patient data without compromising the size and integrity of the study. However, ongoing hospital restrictions, clinic closures and complexities arising from remote working constraints have slowed Veristat’s data collection, validation and analysis beyond the timeframe envisioned last month. As a result of these new updates from its CRO, the Company anticipates the release of top-line results within six weeks. Antibe confirms that it will remain blinded until Veristat releases these results to the Company.
Dan Legault, Antibe’s CEO, remarked, “Although the world is facing singular challenges in light of the COVID-19 health crisis, we are fortunate to have successfully completed the collection of data for every patient enrolled in the study. Validating and processing these data is a non-trivial task in the current environment, especially given the study’s large number of sites. Although later than anticipated, we look forward to delivering robust and complete top-line data as soon as possible.”
The Company has benefited from recent warrant exercise activity and had a cash balance of $6 million as of May 1, 2020. Accordingly, Antibe confirms that it is funded beyond the upcoming data readout.
ATB-346 is a hydrogen sulfide-releasing derivative of naproxen. Nonsteroidal anti-inflammatory drugs (“NSAIDs”) are the most commonly used therapy for osteoarthritis, but their use is associated with a high incidence of gastrointestinal ulceration and bleeding. NSAIDs are also widely used in conditions such as rheumatoid arthritis, ankylosing spondylitis, gout, and general pain reduction, with a similarly high rate of gastrointestinal ulceration and bleeding. It is well-accepted that patients with these conditions would benefit greatly from an effective, non-addictive, GI-sparing anti-inflammatory/analgesic agent such as ATB-346. The current Phase 2 dose-ranging, efficacy study is designed to validate ATB-346’s effectiveness compared to placebo in reducing osteoarthritis pain.
About Antibe Therapeutics Inc.
Antibe develops safer, non-addictive medicines for pain and inflammation. Antibe’s technology involves the linking of a hydrogen sulfide-releasing molecule to an existing drug to produce an improved medicine. Antibe’s lead drug, ATB-346, targets the global need for a safer, non-addictive drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a non-addictive analgesic for treating post-surgical pain, while ATB-340 is a GI-safe derivative of aspirin. Citagenix Inc., an Antibe subsidiary, is a market leader and worldwide distributor of regenerative medicine products for the dental marketplace. www.antibethera.com.
Forward Looking Information
This news release includes certain forward-looking statements, which may include, but are not limited to, the proposed licensing and development of drugs and medical devices. 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 secure additional financing and licensing arrangements on reasonable terms, or at all, its inability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. Antibe Therapeutics 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.