MediciNova Reports FDA Approval Of Second Phase 2 Protocol For MN-001 In NASH

(RTTNews) - MediciNova Inc.(MNOV) announced that the U.S. Food and Drug Administration has approved a second protocol for a clinical trial evaluating MN-001 (tipelukast) for a NASH indication. This study targets NASH patients with hypertriglyceridemia to evaluate the ability of MN-001 to improve cardiovascular risk by assessing cholesterol-efflux capacity and serum triglyceride levels as well as reduction of percent fat in the liver, as assessed by MRI.

The Phase 2 trial is a single-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in subjects with nonalcoholic steatohepatitis (NASH) and hypertriglyceridemia. Eligible subjects will consist of males and females ranging in age from 21 to 65 years old, inclusive. To be eligible, subjects must have a histologically confirmed diagnosis of NASH within 6 months prior to the baseline visit and an elevated serum triglyceride (> 150 mg/dL) during the Screening Phase.

Approximately twenty (20) qualifying subjects will be given MN-001 250 mg orally administered once a day for the first 4 weeks and will be given MN-001 250 mg twice a day for an additional 8 weeks. Overall, the study timeline consists of a Screening Phase (up to 4 months) followed by a Treatment Phase (12 weeks), and a Follow-up visit (within 1 week after the last dose).

The primary efficacy endpoints of the study are to evaluate the effect of MN-001 on 1) Triglyceride levels in NASH subjects with hypertriglyceridemia, and 2) Cholesterol Efflux Capacity in NASH subjects with hypertriglyceridemia. Secondary endpoints include safety and tolerability of MN-001, PK profile of MN-001/MN-002 (by-product of MN-001), effects of MN-001 on HDL-C, LDL-C, and total cholesterol level, and effects of MN-001/002 on liver enzymes and percent fat in liver assessed using MRI at Week 12.

Nonalcoholic steatohepatitis (NASH) is a condition in which there is fat in the liver along with inflammation and damage to liver cells. NASH is a common liver disease that resembles alcoholic liver disease but occurs in people who drink little or no alcohol.