MediciNova Inc. (NASDAQ:MNOV; JASDAQ:4875) shares rose Monday on news it will stop early a Phase IIa trial of tipelukast (MN-001) to treat non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD) after an interim analysis showed that the product met the primary endpoint of reducing mean serum triglycerides. The company said it will "accelerate further development" of the candidate, but did not respond to inquiries.
MediciNova climbed $1.93 (19%) to $12.15 on NASDAQ, and gained ¥112 to ¥1352 in Tokyo.
Tipelukast significantly reduced mean serum triglycerides to 185.2 mg/dL at eight weeks compared with 260.1 mg/dL at baseline (p=0.00006).
The open-label trial was to enroll about 40 NASH and NAFLD patients with hypertriglyceridemia. Its primary endpoints were evaluating the change from baseline to week 12 in cholesterol efflux capacity and serum triglyceride levels. Data from the interim analysis will be presented at the European Association for the Study of the Liver meeting on April 13 in Paris.
MediciNova holds tipelukast's exclusive, worldwide rights outside of Japan, China, South Korea and Taiwan from Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569) under a 2002 deal.
Tipelukast is a leukotriene receptor antagonist and inhibitor of phosphodiesterase-3 (PDE-3), PDE-4 and 5-lipoxygenase (ALOX5; 5-LO). It has Fast Track designation in the U.S. to treat NASH with fibrosis.
Monday's stock move erases MediciNova's 15% loss on NASDAQ last Thursday after the company reported that its ibudilast (MN-166) missed the primary endpoint in a Phase II trial to treat methamphetamine dependence (see BioCentury Extra, March 29).