MediciNova's Phase II NASH Trial To Be Stopped Early, Shows Positive Results

(RTTNews) - MediciNova Inc. (MNOV) is terminating its phase II clinical trial of MN-001 in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with hypertriglyceridemia early based on the significant positive results from an interim analysis.

Non-alcoholic steatohepatitis, or NASH, refers to liver inflammation due to fat buildup in the liver. NASH is a more severe form of nonalcoholic fatty liver disease, or NAFLD.

MN-001, also known as Tipelukast, is an investigational oral anti-inflammatory/anti-fibrotic therapeutic.

The phase II study is designed to enroll 40 subjects with NASH with hypertriglyceridemia and NAFLD with hypertriglyceridemia. This 12-week phase II study was initiated in March 2016, and participants are dosed with MN-001 250 mg once daily for 4 weeks, followed by MN-001 250 mg twice daily for 8 weeks.

The objectives of the study are to evaluate the effect of MN-001 on serum triglyceride levels; cholesterol efflux capacity, safety and tolerability; PK profile; HDL-C, LDL-C, and total cholesterol level, liver enzymes and percent fat in liver at Week 12.

The interim analysis of the phase II study reveals that MN-001 significantly reduced mean serum triglycerides, a primary endpoint, from 260.1 mg/dL before treatment to 185.2 mg/dL after eight weeks of treatment. There were no clinically significant safety or tolerability issues during the study.

Now that the study has achieved the most important endpoint, MediciNova will discontinue enrollment and stop the study in order to accelerate further development of MN-001.

Details of the interim analysis will be presented on April 13, 2018 at the International Liver Congress 2018.

MNOV closed Thursday's trading at $10.22, down 14.55%. MediciNova is listed in both the U.S. and Japan. When we first alerted our premium subscribers to MNOV on July 25, 2013, (Report titled "There's Substance Behind The Wait…"), the stock was trading around $2.70.

Related Reading

The Race To Find A Treatment For NASH