Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba®. The FDA indicated its agreement with Bionovo's plan. This agreement provides the necessary groundwork for the Company to progress to pivotal phase 3 clinical testing.
Menerba is a botanically derived drug candidate designed for the safe and effective treatment of vasomotor symptoms (hot flashes) associated with menopause. It is estimated that there are 40 million women in the U.S. and 37 million in Europe suffering from symptoms associated with menopause. The only FDA approved drugs for this indication are hormone replacement therapies with known serious side effects, including breast cancer. Menerba's Phase 2 clinical trial indicated it is well tolerated with no serious side effects and statistically superior to placebo in reducing the number of hot flashes in menopausal women.
With the FDA's agreement regarding the Company's CMC plan, Bionovo is now in final discussions with the FDA to complete the design of the Phase 3 pivotal trial in the U.S. Upon finalization, the Company expects to quickly commence enrollment.
"We are extremely pleased with the outcome of these meetings. We recognize the care and prudence that the FDA must take in considering our drug which may be used by millions of women," said Dr. Isaac Cohen, Bionovo's Chairman and Chief Executive Officer. "The outcome of these discussions with the FDA constitutes a breakthrough in the history of botanical drug development."
Dr. Cohen continued, "The FDA accepted our combined innovative analytical approaches to the drug's characterization and consistency as well as the process change from the Phase 2 material. As with all drugs proposing manufacturing process changes, prior to clinical dosing, Bionovo will complete a 28 day bioequivalence study in rats. The agency also requested that Bionovo provide selected batch records for review. It is important to remember that Menerba was effective in Phase 2 and showed no signs of safety concerns in human or animal studies to date."
"With the CMC preparations complete, we can now turn our attention to finalizing the communication on the clinical trial design with the FDA in the coming weeks," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "We expect to be able to initiate pivotal trials by year end."
Previously, the Company received final guidance from the European Medicines Agency (EMA) in order to advance Menerba to Phase 3 clinical trials in Europe. The EMA guidance defines the clinical and regulatory pathway to a European marketing authorization for Menerba. With this EMA guidance, and the FDA guidance, the Company is now preparing for pivotal clinical trials in the U.S. and Europe.
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