Cenicriviroc displays favorable outcomes for fatty liver, obesity

Cenicriviroc was well-tolerated and associated with improvements in insulin sensitivity in patients with obesity and fatty liver disease, according to interim results of Tobira Therapeutics’ phase 2a ORION study.

“These new data in obese patients with [nonalcoholic fatty liver disease] or [nonalcoholic steatohepatitis] suggest that [cenicriviroc] can address metabolic abnormalities as well,” Stephen A. Harrison, MD, chief of hepatology at Brooke Army Medical Center, said in a press release. “This is important, as this early population is reflective of patients who are at risk of progression, and these interim results suggest that [cenicriviroc] has the potential to impact NASH.”

The ORION study will evaluate the treatment effects of cenicriviroic (CVC, Tobira) 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, in 50 adults with obesity, prediabetes or diabetes and suspected NAFLD. The primary outcome of ORION will measure changes in insulin sensitivity in peripheral and adipose tissue during a 24-week period.

In the interim analysis, 35 patients were dosed with either CVC or placebo for 12 weeks. The mean baseline fasting plasma glucose level was 122.31 mg/dL, mean baseline HbA1c was 6.25 and 50% were diagnosed with NASH. Interim analysis showed reductions of –11.52 mg/dL in fasting plasma glucose level and –0.36 in HbA1c after 12 weeks of treatment compared with baseline, according to the release.

“Preliminary findings from the pre-planned 12-week interim analysis show that CVC treatment was associated with improvements in multiple glucose parameters. In addition to the previously known anti-inflammatory and anti-fibrotic effects, these preliminary data on improved insulin sensitivity are encouraging and further support the therapeutics potential for CVC in NASH,” Eric Lefebvre, MD, chief medical officer at Tobira, said in the release.

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

The FDA granted fast track designation to cenicriviroc as a potential therapy to treat adults with NASH and liver fibrosis in January 2015.

Disclosure: Lefebvre is employed by Tobira. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Harrison at the time of publication.