Intercept Pharmaceuticals, Inc. ICPT announced that it has initiated a phase I study on pipeline candidate, INT-767.
INT-767, a dual farnesoid X receptor (FXR) and TGR5 agonist, is Intercept’s second bile acid analog in clinical development.
The candidate is being evaluated for the prevention and reversion of organ damage in liver fibrosis patients. The company will assess safety and pharmacokinetics of INT-767 in a single-ascending dose escalation phase. This will be followed by a multiple-ascending dose phase conducted among healthy volunteers.
INT-767 is estimated to be three-times more potent as an FXR agonist than Intercept’s lead product, obeticholic acid (OCA).
Intercept is currently evaluating OCA for an array of chronic liver diseases – primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia.
We remind investors that OCA was granted breakthrough therapy designation for the treatment of NASH with liver fibrosis in the U.S. The FDA also granted fast track designation to OCA for the treatment of patients with PBC. OCA also enjoys orphan drug status both in the U.S. and Europe for the treatment of PBC and PSC.
A response by the FDA on OCA’s approval for PBC is expected by Feb 29. A potential approval of the candidate will be a significant boost for Intercept as the company does not have any approved products in its kitty.
Intercept carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Anika Therapeutics ANIK, Pluristem, Inc. PSTI and Baxalta Inc. BXLT. All three sport a Zacks Rank#1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment