Biotech company Bionovo has begun a Phase 3 clinical trial designed to assess the safety and efficacy of two doses of oral estrogen receptor beta (ER-b) selective drug, Menerba (MF101), used to treat menopausal hot flashes.
The Phase 3 multicentre double-blind placebo-controlled clinical trial will randomise 1,200 postmenopausal women between the ages of 40 and 65 to Menerba 5g/day, Menerba 10g/day or a placebo for 12 weeks.
Efficacy will be measured by the reduction of moderate to severe hot flushes from baseline to 12 weeks of treatment.
Mary Tagliaferri, Bionovo president and chief medical officer, said earlier toxicology data and the mechanism of action, showed that higher doses of Menerba were safe and demonstrated a level of efficacy similar to hormone therapy.
Bionovo chairman and CEO Isaac Cohen added that the results from the trial will be submitted to the Food and Drug Administration for approval.
”We expect to have top-line data from this study in approximately 18 months," he said.