MediciNova: Results from phase 2/ 3 anxiety trial with MN-305 warrant more studies

By E. Janene Geiss

Philadelphia, June 12 - MediciNova, Inc. announced Sunday that results of its phase 2/ 3 randomized, double-blind, placebo-controlled clinical trial of MN-305 showed trends of improvement in all efficacy outcome measures.

In the trial of 416 patients with generalized anxiety disorder, statistically significant improvements in item 1 of the HAM-A were observed through eight weeks of treatment with MN-305; however, statistical significance on the primary outcome measure of the trial was not achieved, according to a company news release.

MN-305 was well-tolerated at all doses in the trial.

"The findings in the latest trial with MN-305 were sufficiently positive and encouraging to warrant further clinical evaluation of this novel drug," Yuichi Iwaki, executive chairman and chief executive officer of MediciNova, said in the release.

The company said it intends to start a new phase 2/ 3 trial of MN-305 later this year that focuses on improvements in the psychic symptoms of anxiety disorder and on exploring an extended dose range.

MN-305 is a novel, potent and highly selective serotonin 5-HT1A receptor agonist under development by MediciNova for the treatment of anxiety disorders beginning with general anxiety disorder.

In addition to the results from the latest clinical trial, this orally bioavailable compound showed preliminary evidence of efficacy in animal models of anxiety and in an open-label study conducted in Japan by Mitsubishi Pharma Corp. in a group of patients with a variety of anxiety disorders.

Likewise, as in the latest clinical trial, MN-305 was well-tolerated in previous clinical studies involving more than 800 volunteers and patients with either anxiety or mood disorders.

MediciNova acquired a license to MN-305 from Mitsubishi Pharma for global markets, with the exception of Japan and other selected Asian countries.

The data acquired from Mitsubishi includes extensive preclinical and clinical safety data, including that from full carcinogenicity testing in rodents.

MediciNova is a San Diego pharmaceutical company.

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