NGM's lead candidate positive in PhII liver disease trial

Phase II data from NGM Biopharmaceuticals' NGM282 in patients with primary biliary cirrhosis (PBC) show the product demonstrated significant, dose-dependent and clinically meaningful reductions in alkaline phosphatase (ALP), a primary indicator of disease activity, as well as reductions in 7α-Hydroxy-4-cholesten-3-one (C4), a marker of bile acid synthesis. NGM282 did not exacerbate pruritus, a common symptom of PBC, NGM noted. The privately held company said the data suggest that NGM282, an engineered protein variant of the human hormone FGF19, is a potent regulator of bile acid synthesis. The product was not included in NGM's recent deal with Merck & Co, where the big pharma spent $96m up front and a further $106m to own a 15% share in NGM plus at least $250m in R&D funding during the next five years. The transaction gave Merck an initial license for NP201, NGM's preclinical candidate for diabetes, obesity and non-alcoholic steatohepatitis (NASH). NGM raised $50m in series C round in mid-2013 – bringing its venture capital total since 2008 to about $130m.