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news.MediciNova's drug candidate MN-305 has posted mixed data in a phase II/III trial evaluating the drug in 416 patients with generalized anxiety disorder. The drug missed its primary endpoint in the trial but showed sufficient efficacy in other measures observed for the company to continue development of the drug.
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Statistical significance on the primary outcome measure of the trial of change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score was not achieved, however, statistically significant improvements in item 1 of the HAM-A (anxious mood) were observed through eight weeks of treatment with the drug. The drug was also shown to be 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,” said Dr Yuichi Iwaki, CEO of MediciNova. “We intend to initiate a new phase II/III trial of MN-305 later this year focusing on improvements in the psychic symptoms of GAD 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 GAD.