28 November 2018 - - Canadian pain and inflammation therapeutics developer Antibe Therapeutics Inc. (TSX Venture: ATE) (OTCQB: ATBPF) has completed part one of the Phase 2B dose-ranging, efficacy study for its lead drug, ATB-346, the company said.

The study was conducted in 24 healthy volunteers who were randomized to once daily doses of ATB-346 at 250 mg, 200 mg or 150 mg.

The primary objectives of the study were to: evaluate cyclo-oxygenase inhibition to inform the doses of ATB-346 to be used in part two, the upcoming dose-ranging, efficacy study; obtain a series of blood samples at distinct time intervals to facilitate analysis of the principal metabolites of ATB-346; and further assess the overall safety and tolerability of the drug.

The blood samples were successfully collected over the 7-day treatment period. COX enzyme activity was assessed through the measurement of thromboxane synthesis, a known biomarker that can be measured in the blood.

NSAIDs exert analgesic and anti-inflammatory effects through inhibition of COX activity. The COX inhibition data of the 250 mg dose was consistent with the Phase 2A and Phase 2B studies, and marked inhibition was also observed with the two lower doses.

This provides management with confidence in the initial selection of the doses to be used in the upcoming dose-ranging, efficacy study.

Additionally, comprehensive analysis is underway to characterize the pharmacokinetic profile of each principal metabolite of ATB-346. The drug was also safe and well tolerated.

Part two of the Phase 2B dose-ranging, efficacy study remains on track to commence in January 2019 with a top-line data read-out anticipated in 2Q19.

This will be a double-blind, placebo-controlled study and will be conducted in approximately 250 osteoarthritis patients. The primary objective is to evaluate the efficacy of three doses of ATB-346 in reducing pain.

ATB-346 is a hydrogen sulfide-releasing derivative of naproxen. Nonsteroidal anti-inflammatory drugs are the most commonly used therapy for osteoarthritis, yet 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 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.