9 July 2018 - - Toronto, Canada-based patent protected pharmaceutical developer Antibe Therapeutics Inc. (TSX Venture: ATE, OTCQX: ATBPF) has released secondary endpoint data from the recent phase 2B gastrointestinal (GI) safety study for its lead drug, ATB-346, the company said.
The double-blind study was conducted in 244 healthy volunteers and was designed to demonstrate the superiority of ATB-346 in GI safety compared to nonsteroidal anti-inflammatory drug (NSAID) naproxen.
The primary endpoint was met previously when subjects on ATB-346 exhibited a 3mm ulceration rate of 2.5% versus an ulceration rate of 42.1% for naproxen at the end of the 2-week treatment period.
The main secondary endpoint was met when no subjects treated with ATB-346 exhibited ulcers of more than 5 mm diameter versus 24% of subjects treated with naproxen, with an average of 2.5 ulcers per subject.
ATB-346 is a hydrogen sulfide-releasing derivative of naproxen. NSAIDs, widely used in conditions such as rheumatoid arthritis, ankylosing spondylitis, gout, and general pain reduction, are associated with a high incidence 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 and analgesic agent.
Antibe develops safer medicines for pain and inflammation. Its technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine.