- Annual Meeting
CEO: Mark Silverman
FT-012 for the treatment of acute hepatic encephalopathy Westhaven Therapeutics Corporation FT-012 is a synthetic tectosilicate that selectively adsorbs cations such as ammonia, strontium, cadmium, zinc, lead, and cesium and is undergoing development for the treatment of hepatic encephalopathy (HE). In vitro studies have demonstrated the ammonia binding activity of FT-012 of 83% to 95% of ammonia at the 120 ppm level and similar sequestration at an approximate doubling of the ammonia concentration. FT-012 adsorbs lead and cesium with an affinity approximately similar to and higher than ammonia respectively. FT-012 has demonstrated in vivo activity in a rodent HE model with an approximate 40% reduction in portal venous ammonia levels when administered after the animals had been rendered hyperammonemic. In a porcine model of HE, FT-012 demonstrated a dose-dependent decrease in systemic venous ammonia, and in an ovine HE model, FT-012 reduced systemic venous ammonia levels by 40% and improved symptoms of HE. In bovines exposed to high amounts of ammonia generating food supplements FT-012 reduced circulating venous ammonia. Pharmacokinetic studies in rats, dogs, and primates showed that FT-012 is not absorbed from the gastrointestinal tract and it is fecally eliminated. Acute and chronic toxicology studies (including 2-year carcinogenicity in rats) revealed no overt symptoms of toxicity even at very high FT-012 doses. FT-012 is not mutagenic, teratogenic, clastogenic or genotoxic in any in vitro or in vivo system studied to date. FT-012 is orphan designated for the treatment of HE and an IND for the study of FT-012 in HE is active, with clinical studies poised for initiation in 2015.