Firm is preparing to meet with the FDA to establish parameters for a Phase III trial in primary biliary cirrhosis.
Intercept Pharmaceuticals reported the completion of a $25 million Preferred Series B financing by its majority shareholder Genextra. The financing will enable the company to advance clinical programs as well as continue to build its pipeline of small molecules targeting FXR, TGR5, and other bile acid receptors, notes Mark Pruzanski, founder, president, and CEO.
Intercept Pharmaceuticals is developing therapeutics for chronic fibrotic and metabolic diseases. The company’s most advanced programs are focused on the development of modified bile acids that are selective for farnesoid X receptor (FXR), a nuclear receptor, and TGR5, a G protein-coupled receptor. Bile acid signaling through these receptors regulates key aspects of lipid, glucose, and overall energy metabolism while also serving to maintain the functional integrity of the liver, intestine, and kidney.
INT-747 is an FXR agonist derived from the primary human bile acid chenodeoxycholic acid, the natural endogenous FXR agonist. In 2009, the company announced positive Phase II results with the compound in refractory primary biliary cirrhosis (PBC) patients as well as in type 2 diabetics with nonalcoholic fatty liver disease. Intercept is currently preparing for a meeting with the FDA to determine a Phase III program in PBC.
INT-777, a modified human bile acid, is a TGR5 agonist that induces the release of GLP-1 in the gut and normalizes glucose tolerance in obese, insulin-resistant, and diabetic mice. INT-777 also prevents weight gain and fat accumulation in mice on a high-fat diet by increasing energy expenditure and fat burning while preserving liver function by reducing steatosis and fibrosis. Intercept intends to file an IND for INT-777 in the third quarter of 2010.
In conjunction with the financing, Lorenzo Tallarigo, CEO of Genextra and Intercept director, is assuming the role of chairman. Dr. Tallarigo states, “This financing adds substantially to Genextra’s investment in Intercept. With two positive Phase II studies last year, the company has made great progress in validating the therapeutic utility of INT-747 and the novel class of compounds it belongs to more broadly.”