TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Inc. ("Antibe" or the “Company”) (TSXV:ATE, OTCQB:ATBPF), a leader in developing safer therapeutics for pain and inflammation, is pleased to announce that its Phase 2B dose-ranging, efficacy study for ATB-346 has formally commenced. Enrollment is open, clinical sites have been activated and patients will now begin screening.
The study is designed to validate the efficacy of ATB-346 in reducing osteoarthritis (“OA”) pain and establish the dose for Phase 3 development. 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.
“We are excited to officially commence the final Phase 2 study for ATB-346,” commented Dan Legault, Antibe’s CEO. “A successful outcome in this large clinical trial will further validate the best-in-class potential of ATB-346, and will represent a major inflection point as we position ourselves for Phase 3 development and global partnering discussions.”
The study is being conducted by Veristat, Inc. (“Veristat”) in approximately 35 clinical sites across Canada and is expected to have a top-line data read-out this summer.
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. 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.