TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. ("Antibe" or the “Company”) (TSXV: ATE, OTCQB: ATBPF), a leader in developing safer therapeutics for pain and inflammation, today provides an update on the Phase 2B dose-ranging, efficacy study for its lead drug, ATB-346. The clinical study commenced in March 2019 and is designed to validate the efficacy of ATB-346 in reducing pain and establish the dose for Phase 3 development. A total of 360 patients with osteoarthritis of the knee are being randomized to either placebo or one of three doses of ATB-346 administered once daily: 150 mg, 200 mg or 250 mg.
The clinical trial is proceeding well and the Company is pleased with the execution and quality of patient screening, which determines admittance into the study across the 35 clinical sites. Previous guidance for enrollment of the last patient had been late calendar Q3 2019, but this will now occur in calendar Q4 2019. The delay is largely the result of the rigorous screening discipline and a temporary slowdown in patient recruitment due to the summer holiday period.
Dan Legault commented, “We have designed our clinical trial in a rigorous way and have been successful to-date in recruiting suitable patients to ensure a robust set of data. Although this has mildly delayed our timelines, we view data quality as paramount for this trial. With the recent successful financing, we’re adequately capitalized to complete the trial while funding continued development of our other programs, and anticipate being in a strong position to negotiate potential partnerships upon a successful study outcome.”
Antibe will issue another press release upon final enrollment of the last patient in the study.
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.
About Antibe Therapeutics Inc.
Antibe develops safer, non-addictive medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, 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 severe acute 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 expressions. 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 Inc. 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.