NEW YORK, NY, USA I November 30, 2015 I Intercept Pharmaceuticals, Inc. (ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, today announced the initiation of a Phase 1 study of INT-767, a dual farnesoid X receptor (FXR) and TGR5 agonist, in healthy volunteers.
INT-767 is Intercept’s second bile acid analog to enter clinical development, and is a three-fold more potent FXR agonist than obeticholic acid (OCA), Intercept’s lead product candidate. INT-767 also activates TGR5, a second bile acid receptor. TGR5 has been shown to affect energy metabolism, glucose homeostasis, bile composition/secretion, and inflammation. INT-767 has potentially promising preclinical activity in both preventing and reversing organ damage due to fibrosis.
The goal of the Phase 1 study will be to assess safety and pharmacokinetics in a single ascending dose escalation phase followed by a multiple ascending dose phase in healthy volunteers.
“Advancing INT-767 into clinical development is another important milestone as we work to develop a portfolio of differentiated products to treat chronic liver diseases with high unmet medical need,” said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept. “We believe INT-767 has exciting clinical potential based on extensive preclinical study, and we look forward to the first clinical data to guide future development.”
About Intercept
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases. The Company’s lead product candidate, obeticholic acid (OCA), is an agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. The FDA has granted OCA breakthrough therapy designation for the treatment of NASH with liver fibrosis and granted OCA fast track designation for the treatment of patients with PBC. OCA has also received orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Intercept owns worldwide rights to OCA outside of Japan, China and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. Intercept’s pipeline of product candidates includes other novel bile acid analogs such as INT-767, which is in clinical development. For more information about Intercept, please visit the Company’s website at: www.interceptpharma.com.
SOURCE: Intercept Pharmaceuticals
Post Views: 99
NEW YORK, NY, USA I November 30, 2015 I Intercept Pharmaceuticals, Inc. (ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, today announced the initiation of a Phase 1 study of INT-767, a dual farnesoid X receptor (FXR) and TGR5 agonist, in healthy volunteers.
INT-767 is Intercept’s second bile acid analog to enter clinical development, and is a three-fold more potent FXR agonist than obeticholic acid (OCA), Intercept’s lead product candidate. INT-767 also activates TGR5, a second bile acid receptor. TGR5 has been shown to affect energy metabolism, glucose homeostasis, bile composition/secretion, and inflammation. INT-767 has potentially promising preclinical activity in both preventing and reversing organ damage due to fibrosis.
The goal of the Phase 1 study will be to assess safety and pharmacokinetics in a single ascending dose escalation phase followed by a multiple ascending dose phase in healthy volunteers.
“Advancing INT-767 into clinical development is another important milestone as we work to develop a portfolio of differentiated products to treat chronic liver diseases with high unmet medical need,” said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept. “We believe INT-767 has exciting clinical potential based on extensive preclinical study, and we look forward to the first clinical data to guide future development.”
About Intercept
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases. The Company’s lead product candidate, obeticholic acid (OCA), is an agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. The FDA has granted OCA breakthrough therapy designation for the treatment of NASH with liver fibrosis and granted OCA fast track designation for the treatment of patients with PBC. OCA has also received orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Intercept owns worldwide rights to OCA outside of Japan, China and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. Intercept’s pipeline of product candidates includes other novel bile acid analogs such as INT-767, which is in clinical development. For more information about Intercept, please visit the Company’s website at: www.interceptpharma.com.
SOURCE: Intercept Pharmaceuticals
Post Views: 99
