MediciNova Halts Trial Early Following Positive Interim Analysis

Clinical Trials Research

Investors in La Jolla, Calif.-based MediciNova are celebrating this morning as company shares are up more than 18 percent following the early completion of a mid-stage non-alcoholic steatohepatitis trial.

An interim analysis of Phase II data showed that MN-001 (tipelukast) yielded significant positive results in the treatment of patients with NASH and non-alcoholic fatty liver disease (NAFLD) with hypertriglyceridemia. The interim data showed MN-001 significantly reduced mean serum triglycerides in patients over a period of eight weeks. MN-001 reduced the mean serum triglycerides from 260.1 mg/dL before treatment to 185.2 mg/dL after eight weeks of treatment. That reduction was a primary endpoint of the mid-stage trial, the company said.

Not only did MN-001 show significant reductions of the mean serum triglycerides, MediciNova said there were no clinically significant safety or tolerability issues during the study.

MN-001 is orally bioavailable small molecule compound that inhibits phosphodiesterases (PDE) 3 and 4. Additionally, the drug is also an inhibitor of 5-lipoxygenase, a pathway that has been speculated to be a factor in fibrosis development.

“Having achieved the most important endpoint of the study, MediciNova will discontinue enrollment and stop the study in order to accelerate further development of MN-001,” the company announced this morning.

A more detailed report of the interim analysis of the Phase II trial will be presented at the International Liver Congress 2018 later this month, the company said.

“We are thrilled with the results of this study, which showed a large reduction in triglycerides. Based on the results of this study, along with the triglyceride data we have from prior clinical studies of MN-001 in other indications, we believe that MN-001 has potential to benefit a wide range of patients with hypertriglyceridemia, not limited to those with NASH and NAFLD,” Yuichi Iwaki, MediciNova’s president and chief executive officer, said in a statement.

NASH is a progressive form of fatty-liver disease that has been directly associated with diabetes and obesity. Excessive accumulation of fat in the liver induces chronic inflammation, which causes progressive fibrosis, cirrhosis and eventually end-stage liver disease. The prevalence of NASH is increasing worldwide in part due to the increase in obesity and diabetes diagnoses. NASH is projected to become the leading indication for liver transplant by 2020.

The early halting of the Phase II trial was good news for a company that only days ago reported its Phase II trial of ibudilast (MN-166) failed to meet its primary endpoint for methamphetamine dependence. That news sent shares of MediciNova stock down about 15 percent at the end of the week. Today’s news helped the company regain what it lost. While ibudilast failed in the methamphetamine dependence study, the drug is involved in multiple clinical trials for MediciNova.

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