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FDA Accepts Application of Cenicriviroc for Primary Sclerosing Cholangitis
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Tobira Therapeutics announced that the FDA and Health Canada have accepted its investigational new drug and clinical trial applications for review of cenicriviroc for the treatment of primary sclerosing cholangitis.
Cenicriviroc (Tobira Therapeutics), or CVC, is an oral, potent immunomodulator that blocks chemokine receptors that can cause liver damage and lead to liver disease. According to the release, a phase 2 clinical study evaluating the safety and efficacy of 150 mg of CVC in 25 patients with PSC over a duration of 24 weeks is planned for initiation in the first quarter of 2016. The primary endpoint will be any alteration to serum alkaline phosphatase levels.
“Acceptance of the [investigational new drug and clinical trial applications] 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,” Laurent Fischer, MD, CEO of Tobira, said in the release. “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.”
The FDA granted fast track designation to cenicriviroc as a potential therapy to treat adults with nonalcoholic steatohepatitis and liver fibrosis in January 2015.
Disclosure: Fischer is employed by Tobira Therapeutics.