Phase 2 clinical trial of the gi safety of a hydrogen sulfide-releasing anti-inflammatory drug (atb-346)

Abstract

Hydrogen sulfide (H2S) is a naturally occurring gaseous mediator produced by intestinal bacteria and various eukaryotic cells. H2S exerts anti-inflammatory, pro-resolution and cytoprotective effects in vivo. ATB-346 is an H2S-releasing derivative of naproxen, which in animals was shown to produce negligible gastrointestinal (GI) damage and bleeding. In human studies, ATB-346 was found to be much more potent and long-lasting than naproxen. A phase 2 open-label efficacy study demonstrated that ATB-346 (250 mg daily) significantly reduced pain in patients with osteoarthritis of the knee, and markedly suppressed cyclooxygenase (COX) activity. The aim of the present study was to determine if ATB-346 would induce less gastroduodenal ulceration than standard dose naproxen