Avera Pharmaceuticals - Gantacurium Chloride

Gantacurium has successfully completed a Phase 2 clinical study, where it was used as an adjunct to general anesthesia to enable rapid intubation of patients undergoing surgery. Gantacurium Chloride is a new, investigational, non-depolarizing ultra-short acting neuromuscular blocker.

The Phase 2 study was a multi-center, randomized, controlled, observer-blinded dose-response study, designed to evaluate the efficacy and safety of gantacurium chloride for injection in healthy adult patients undergoing endotracheal intubation prior to surgery under general anesthesia. The study enrolled 230 subjects with American Society of Anesthesiologists (ASA) physical status classification 1 and 2 (healthy or mild systemic disease), who were given gantacurium, succinylcholine or placebo. The study met its primary outcome endpoint, achieving greater than 90% acceptable intubations at 60 seconds after injection. Gantacurium was well tolerated and no serious adverse events were observed.

Prior to licensure from GlaxoSmithKline, gantacurium had been evaluated in a Phase 1 study which demonstrated excellent safety and potent neuromuscular blocking effects. Following acquisition, Avera completed the Phase 1 and Phase 2 development of this asset. Avera is currently seeking to outlicense development and commercialization rights for gantacurium.