Bionovo, Inc. (NASDAQ: BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced the positive results from the completion of their tolerability trial of Menerba™ (MF101) for menopausal hot flashes.
The open-label, randomized, clinical trial of Menerba was conducted at four U.S. clinical sites. Postmenopausal women between the ages of 40 and 65 years were randomized to one of two doses of Menerba and treated for 28 days. The primary goal of the study was to assess the safety and tolerability of two doses of Menerba, higher than those previously tested during the Phase 2 studies, after 4 weeks of treatment. This study allowed Bionovo to identify the optimal dosages for the planned Phase 3 studies. Dr. Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University served as the Principal Investigator for the study.
A total of 35 postmenopausal women with an average age of 53, who at baseline had on average 73 hot flashes per week, were enrolled to the trial. The primary endpoint of the study was to test the safety of two higher doses of Menerba. There were no reported cases of serious adverse events, no abnormal findings on endometrial biopsies, no abnormal lab results, no changes to blood pressure, heart rate or weight and no concerning side effects from the treatments. The Company has established a definitive dosing strategy for the Phase 3 clinical trial.
"I am extremely pleased by the positive findings from our study which continue to show that Menerba is a safe therapy for the treatment of menopausal hot flashes. As predicted by the dose response seen in our Phase 2 trial, higher doses of Menerba tested in our Phase 1 study demonstrated higher efficacy. We were encouraged by the robust clinical effect of Menerba to reduce hot flashes after just 4 weeks of treatment," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "The participants enrolled to the trial had an average number of 73 weekly hot flashes at baseline. After 4 weeks on therapy, the reduction in moderate to severe hot flashes was approximately 70% with a p value of 0.003 for women who took a dose of Menerba that has twice the potency than the highest dose tested in our Phase 2 study. In addition, there was a 68% reduction in the number of nighttime awakenings due to hot flashes with a p value of 0.001. This level of efficacy at 4 weeks is similar to estrogen-based hormone therapy. Moving forward, we will evaluate two doses of Menerba compared to placebo in a definitive Phase 3 randomized, double-blind, placebo-controlled clinical trial."
"We are pleased to report that we continue to meet our stated timelines for the year. We have determined a clear dosing strategy for the upcoming Phase 3 trial of Menerba and we are very encouraged by the totality of our safety and efficacy data from this trial. To this end, we are eager to initiate the Phase 3 clinical trial this fall," stated Dr. Isaac Cohen, Chairman and Chief Executive Officer of Bionovo.
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