Bionovo’s lead drug candidate, MF101, showed positive Phase II results for the treatment of hot flashes associated with menopause.
Two hundred and seventeen women were enrolled in the company’s double-blind, placebo-controlled, randomized Phase II trial. Postmenopausal women with 50 or more moderate to severe hot flashes per week were randomized to one of three treatment groups receiving MF101 (5 grams/day), MF101 (10 grams/day) or placebo for 12 weeks.
Bionovo’s primary objectives in the Phase II clinical trial were to assess the safety, tolerability and the potential efficacy of two doses of MF101 to reduce the frequency and severity of hot flashes. Both doses of MF101 were more effective than placebo at reducing the frequency and severity of hot flashes from the start of the trial until the end of the treatment period 12 weeks later.
The only side effect that increased with MF101 treatment was loose stool or diarrhea (12 percent in each of the drug arms versus 3 percent in placebo arm). Constipation was improved with MF101 therapy.