The Phase 2 clinical trial was designed to evaluate the safety and efficacy of two doses of Menerba versus placebo. The trial was conducted under the direction of Dr. Deborah Grady, an international key opinion leader, from the University of California, San Francisco. The trial was a randomized, double-blinded, placebo-controlled study that enrolled 217 healthy postmenopausal women reporting severe hot flashes, and was conducted at 6 clinical sites in the U.S. Participants were randomized to drug or identical placebo for 12 weeks.
After 12 weeks of treatment, there was a statistically significant decrease in frequency of all hot flashes in the higher dose of Menerba (p=0.04). There was also a very clear dose response trend in multiple efficacy analyses. When compared to placebo, women in the Menerba high dose group were 2.3 times more likely to have at least a 50% reduction in hot flashes after 12 weeks of treatment (OR 2.3, p=0.03).
The study further elucidated that Menerba reduced the number of times women were awakened from sleep due to hot flashes, also known as "night awakenings" or "night sweats." The median percent reduction in night time awakenings from hot flashes for women randomized to the higher dose of Menerba was 67%, and this reduction was statistically superior compared to placebo (p=0.05).
Menerba was extremely well tolerated with 98% of participants completing the trial and 91% taking at least 75% of assigned doses. The only statistically significant side effect was transient loose stools (12% on Menerba versus 3% on placebo; p=0.03).
Safety analyses showed no cases of endometrial hyperplasia or uterine cancer during the trial. There were no differences in incidents of vaginal bleeding between the placebo group and the two treatment groups of Menerba. Likewise, there was no increase in blood estradiol levels. This finding further supports that Menerba will not lead to an increased risk for breast or uterine cancers.
This Phase 2 trial of Menerba provided evidence that treatment with Menerba is effective for the treatment of hot flashes in postmenopausal women and the drug is very well tolerated without any significant side effects.
"I am very encouraged and pleased by the findings of this clinical trial," said Deborah Grady, M.D., Associate Dean for Clinical and Translational Science, Professor of Medicine and Director of the University of California, San Francisco (UCSF) Women's Health Clinical Research Center. "The combination of a trend to better efficacy with the higher dose of Menerba and a very strong safety profile of a drug that was extremely well tolerated by menopausal women is exciting news. These early positive clinical results are encouraging for discovering a safer therapy for hot flashes."
"Menerba is an estrogen receptor beta selective drug," said Jan Ake Gustafsson, M.D., the discoverer of estrogen receptor beta, from Houston University and a member of the National Academy of Sciences. "The results from Menerba's first Phase 2 clinical trial support the role of estrogen receptor beta as a novel target for treating menopausal symptoms."
"Large clinical trials, such as the HERS and the WHI, elucidated serious safety concerns associated with hormone therapy. These results have led to a dramatic drop in the use of estrogens," said Isaac Cohen, chairman and CEO of Bionovo, Inc. "For this reason, it is important to develop safer alternatives for treating menopausal symptoms currently affecting 30 million women in the US. Our results indicate Menerba is effective and safe for the treatment of hot flashes and we are eager to move forward with the development of this drug. Clearly, Menerba has the potential to help millions and reach blockbuster sales soon after market launch."
Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit: http://www.bionovo.com.
Forward Looking Statements
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SOURCE Bionovo, Inc.