Immuron adds clinical sites for phase 2 trial of potential NASH drug

Immuron Limited announced it has added more clinical sites to its multinational, multicenter phase 2 trial of IMM-124E, a drug for the treatment of nonalcoholic steatohepatitis, according to a press release.

The trial currently has 19 clinical sites — 13 in the U.S. and six in Australia — and Immuron is working to initiate two sites in Israel and an additional site in the U.S. The goal of the study is to evaluate the safety and preliminary efficacy of IMM- 124E.

According to the Immuron website, IMM-124E is a natural product that contains bovine colostrum powder. The powder is harvested from Australian dairy cows that have been immunized with Immuron’s proprietary lipopolysaccharide vaccine.

“We have established an impressive network of world -leading investigators, and now we expect to see an acceleration in recruitment,” Dan Peres, MD, senior vice president of innovation at Immuron, said in the release.

In December 2014, Immuron initiated the phase 2 trial of IMM-124E, with study protocol being prepared in collaboration with a scientific advisory board led by Arun J. Sanyal, MD, of Virginia Commonwealth University in Richmond, according to the release. The study will include 120 patients with NASH randomly assigned doses of either 600 mg or 1,200 mg of IMM-124E or placebo three times daily for 6 months.

As of now, 33 patients have joined the study. Recruitment for the phase 2 trial is expected to be completed by the end of 2015, according to the release.

In a phase 1/2a trial, oral administration of IMM- 124E was proven to be safe in patients with Type 2 diabetes, hyperlipidemia and NASH, according to the Immuron website.

Disclosures: Peres reports being employed by Immuron.