NGM to chart new course for lead compound

NGM Biopharmaceuticals Inc. (South San Francisco, Calif.) said its NGM282 met the primary endpoint in a Phase II trial to treat primary biliary cirrhosis (PBC), but now plans to study the compound to treat other Orphan bile acid-related diseases. The company said PBC patients may have treatment alternatives before NGM282 could reach the market.

For example, Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) expects to complete the submission of a rolling NDA to FDA this half for OCA obeticholic acid to treat PBC. The molecule has Orphan Drug and Fast Track designations from the agency. Intercept is developing the same candidate to treat non-alcoholic steatohepatitis (NASH). ...