Great to see lots of research activity in PSC area. I have seen couple of new clinical trial being announced recently. This one was today:
SOUTH SAN FRANCISCO, Calif., Jan. 7, 2016 /PRNewswire/ -- Tobira Therapeutics, Inc. (NASDAQ: TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, announced that the U.S. Food and Drug Administration (FDA) and Health Canada have accepted the company's Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, for cenicriviroc (CVC) for the treatment of primary sclerosing cholangitis (PSC).
The company plans to initiate a Phase 2 study later in the first quarter of 2016. The single-arm, open label, proof-of-concept clinical trial will evaluate the effects of 24 weeks of treatment with CVC 150 mg in approximately 25 patients with PSC. The primary endpoint will be the change of serum ALP (alkaline phosphatase) levels.
"Acceptance of the IND and CTA is an important step toward our goal of building a platform with cenicriviroc, a compound we believe can address multiple immuno-inflammatory and fibrotic diseases," said Laurent Fischer, M.D., chief executive officer of Tobira. "We believe CVC has promising clinical potential in patients with primary sclerosing cholangitis, and we look forward to the first clinical data in this indication to guide future development in this rare and life-threatening disease, for which no treatments have been approved and may require a liver transplant."