Antibe Therapeutics Receives Approval to Initiate Part Two of Phase 2B Dose-Ranging, Efficacy Study for ATB-346
Antibe Therapeutics Inc. (“Antibe”) (TSXV:ATE, OTCQB:ATBPF), a leader in developing safer therapeutics for pain and inflammation, is pleased to announce that it has received approval from Health Canada to initiate the second part of its Phase 2B dose-ranging, efficacy study for its lead drug, ATB-346.
Antibe Therapeutics Inc. (“Antibe”) (TSXV:ATE, OTCQB:ATBPF), a leader in developing safer therapeutics for pain and inflammation, is pleased to announce that it has received approval from Health Canada to initiate the second part of its Phase 2B dose-ranging, efficacy study for its lead drug, ATB-346. The primary objective of the study is to evaluate the efficacy of ATB-346 in reducing osteoarthritis (“OA”) pain over a 14-day treatment period. The study will involve a total of 360 patients with OA of the knee, who will be randomized to placebo or one of three doses of ATB-346 administered once daily: 150 mg, 200 mg or 250 mg.
Antibe’s CEO, Dan Legault, commented, “This is an exciting time for Antibe as a significant number of patients will be receiving ATB-346 for the first time to assess efficacy in a controlled setting. A positive outcome in this Phase 2B study will validate the effectiveness of ATB-346 in reducing pain, and will be a breakthrough for patients and physicians. Furthermore, it will unlock significant value for Antibe as we advance global partnering discussions and deepen our understanding of the ideal development path for ATB-346 and our other pipeline drug candidates.”
The study will be conducted by Veristat, Inc. (“Veristat”) in approximately 35 clinical sites across Canada and is expected to commence enrollment shortly. Antibe will update the timing for the trial completion as Veristat informs us of enrollment progress during the coming months.
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 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. www.antibethera.com.
Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the sales and marketing of tissue regenerative products servicing the orthopedic and dental marketplaces. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships. www.citagenix.com.
Forward Looking Information
This news release includes certain forward-looking statements, which may include, but are not limited to, the completion of financing transactions and the 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 ability to secure additional financing, its ability 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.