Interim results 'very promising' for NASH drug solithromycin

Provisional outcomes for Cempra Inc.’s phase 2 study into the efficacy and safety of the potent macrolide solithromycin for patients with nonalcoholic steatohepatitis are encouraging, according to a press release.

“We have been focusing on new treatments for NASH for the past 15 years and the early results we have seen with solithromycin are very promising for a patient population that urgently needs a new treatment option,” Pierre Gholam, MD, of Case Western Reserve University School of Medicine, said in the release.

According to the press release, after 90 days, all six patients with NASH who received solithromycin (Cempra) saw their nonalcoholic fatty liver disease activity score decline an average of 1.3 points and their average alanine aminotransferase lowered by 17.8 U/L. Most patients also saw their aspartate aminotransferase levels decline — for one patient the level remained the same and normal — for an average decline of 10.1 U/L across all patients. No adverse side effects were reported in the current study. Previous clinical trials showed lower inflammation and hepatocyte degeneration levels in patients who received the drug.

“We are very excited to see that these early clinical results with solithromycin in NASH patients are confirming the results we saw in our pre-clinical studies and we look forward to continuing to investigate this important unmet medical need,” Prabhavathi Fernandes, PhD, president and CEO of Cempra, said in the release.

“While this is a small number of patients and further work is required to confirm these data on a wider scale, [these results] allow a good measure of optimism,” Gholam said in the press release.

Cempra will now move forward with plans to gather data from up to 15 patients with NASH, with enrollment expected to be complete in the first quarter of 2017. – by Janel Miller

Disclosures: Fernandes is employed by Cempra. Healio.com/Hepatology was unable to determine Gholam’s relevant financial disclosures at time of publication.