Tobira begins enrollment for ORION study of cenicriviroc for NAFLD

Tobira Therapeutics announced it has enrolled its first patient for its phase 2a clinical trial, known as ORION, which will be investigating the safety and efficacy of cenicriviroc for the treatment of obese patients with nonalcoholic fatty liver disease, according to a press release from the manufacturer.

Cenicriviroc (CVC; Tobira Therapeutics) is an oral, once-daily, potent immunomodulator that blocks the CCR2 and CCR5 receptors, which cause liver damage and often lead to cirrhosis, liver cancer or liver failure, according to the release. The ORION study will evaluate the treatment effects of CVC in 50 obese adults with prediabetes or diabetes and suspected NAFLD. The primary outcome of ORION will measure changes in insulin sensitivity in peripheral and adipose tissue over a 24-week period and will include an interim analysis at 12 weeks, according to the release.

“The ORION study will help us to further understand the full spectrum of potential activity of CVC along the continuum of fatty liver disease,” Laurent Fischer, MD, CEO of Tobira Therapeutics, said in the release. “We expect interim data from ORION in the first half of 2016.”

CVC is currently being investigated in the phase 2b CENTAUR trial, which tests the safety and efficacy of CVC in 289 patients with nonalcoholic steatohepatitis and liver fibrosis. Tobira expects to announce CENTAUR results in the third quarter of 2016.

The FDA granted fast track designation to Tobira Therapeutics for cenicriviroc in January.

Disclosures: Fischer reports being employed by Tobira.