According to investigators MN-001 (tipelukast) reduced mean serum triglycerides, a primary endpoint, from an average of 260.1 mg/dL before treatment to 185.2 mg/dL after eight weeks of treatment, delivering a p value of 0.00006.
They were studying the therapy for NASH and the common second shot at NAFLD — non-alcoholic fatty liver disease. But company execs, coming off a recent setback on its lead drug candidate against methamphetamine dependence, cheered themselves on with a strategy for going after all conditions associated with hypertriglyceridemia.
“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,” said Yuichi Iwaki, CEO of the La Jolla, CA-based company.
There are a variety of drugs being developed for NASH now, with one of the leading programs at Gilead. Researchers have been using a number of primary and secondary goal posts for these studies, and MediciNova is likely to feel something of a backlash about reading big gains for themselves from a small mid-stage study like this.
According to clinicaltrials.gov, the biotech recruited only 40 people for this study, leaving a long, long road ahead in the clinic.
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