2 April 2019 - - Canada-based pain and inflammation therapeutics developer Antibe Therapeutics Inc.'s (TSX Venture: ATE) (OTCQB: ATBPF) Phase 2B dose-ranging, efficacy study for ATB-346 has formally commenced, the company said.

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 pain and establish the dose for Phase 3 development.

This study will involve a total of 360 patients with OA of the knee, who will be randomised to placebo or one of three doses of ATB-346 administered once daily: 150 mg, 200 mg or 250 mg.

The study is being conducted by Veristat, Inc. 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 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.

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. 

Antibe's subsidiary, Citagenix Inc., is 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.