Intercept Pharmaceuticals, a New York-based clinical stage biopharmaceutical company focused on chronic liver diseases, has completed a $30 million Series C preferred stock financing led by OrbiMed Advisors, a global healthcare investment firm, with existing majority investor Genextra of Italy also participating.
"This financing allows us to continue advancing our lead compound OCA in POISE, our phase IIIPBC [primary biliary cirrhosis] trial, while pursuing other therapeutic indications of interest," said Mark Pruzanski, MD, president and CEO of Intercept.
Intercept aims to enroll 180 patients who first enter a one year double-blind placebo-controlled pivotal trial phase, followed by an open label long-term safety extension phase for another five years. The primary endpoint of the pivotal phase is the achievement of an alkaline phosphatase (ALP) level of less than 1.67 times upper limit normal (with at least a 15% reduction in ALP), together with a normal bilirubin level. Patients who attain these ALP and bilirubin thresholds have been shown in long-term studies to be at significantly lower risk of progressing to liver transplant and death.
In conjunction with the financing, OrbiMed's Jonathan Silverstein and Klaus Veitinger have joined Intercept's board of directors.