Bionovo has reported that the first patient has now been randomized and will begin dosing in the phase III pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.
The phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial evaluating Menerba is currently open for enrollment. A total of 50 clinical sites in the U.S. will enroll 1,200 postmenopausal women between the ages of 40 and 65 years. Participants will be randomized to Menerba 5g/day, Menerba 10g/day or placebo and treated for 12 weeks. The primary aims of the study are to determine the safety and efficacy of two doses of Menerba compared to
placebo after 12 weeks of treatment. Efficacy will be measured by the reduction of moderate to severe hot flushes from baseline to 12 weeks of
Menerba is an oral drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause, which is manufactured from botanical sources. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the products currently on the market which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in traditional Chinese medicine (TCM).
Menerba has completed a phase II trial with positive results for efficacy and has been evaluated by an independent Data and Safety Monitoring Board and passed through a standard two-round examination for safety.