US-based MediciNova has met its primary endpoint of reducing mean serum triglycerides in its phase two clinical trial of its MN-001 (tipelukast) drug for treatment of non-alcoholic steatohepatitis and non-alcoholic fatty liver disease with hypertriglyceridemia, it was reported on Monday.
MediciNova stated that it will stop the trial based on significant positive results from interim analysis. According to the company, the product significantly decreased mean serum triglycerides, which is a primary endpoint, from 260.1 mg/dL before treatment to 185.2 mg/dL after eight weeks of treatment. The firm has decided to withdraw recruitment of patients and terminate the study to further accelerate the development of MN-001.
The phase 2a is a multi-centre, proof-of-principle and open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in subjects with non-alcoholic steatohepatitis or non-alcoholic fatty liver disease with hypertriglyceridemia. The company recruited subjects, including males and females aged between 21 and 65 years old.
MN-001 is a novel and orally bioavailable small molecule compound, which is believed to exercise its effects through various mechanisms to produce its anti-inflammatory and anti-fibrotic activity in preclinical models, including leukotriene receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly three and four), and inhibition of 5-lipoxygenase.
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