MediciNova is set to terminate its Phase II clinical trial of MN-001 (tipelukast) for the treatment of non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD) with hypertriglyceridemia, based on the significant positive results from an interim analysis.
Results show MN-001 (tipelukast) to significantly reduce mean serum triglycerides, a primary endpoint of the trial, from 260.1mg/dL before treatment to 185.2mg/dL after eight weeks of treatment.
No clinically significant safety or tolerability issues were reported during the trial.
After achieving the most important endpoint of the trial, MediciNova plans to discontinue enrolment and cancel the study to speed up further development of MN-001.
MediciNova president and CEO Yuichi Iwaki said: “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.”
MN-001 (tipelukast) is a new, orally bioavailable small molecule compound.
It has the potential to exert its effects through several mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE), and inhibition of 5-lipoxygenase (5-LO).
The open-label Phase II trial enrolled male and female patients aged between 21 and 65 years.
Participants had histologically confirmed diagnosis of NASH or imaging study confirmed NAFLD and an elevated serum triglyceride (>150 mg/dL).