MenoGeniX Awarded NIH Grant to Fund Phase Ib/IIa Clinical Trial
MenoGeniX announced that the National Institute on Aging (NIA) of the National Institutes of Health (NIH) has awarded the company a Small Business Innovation Research (SBIR) grant for the clinical development of MNGX-100, a version of a naturally-occurring human blood protein, for the treatment of menopausal hot flashes. The grant will support a Phase Ib/IIa clinical trial evaluating the safety and efficacy of repeated administration of MNGX-100 in 60 women with naturally-occurring or surgically-induced menopause.
“Funding from the NIA/NIH will help us to continue the clinical development of a novel, non-hormonal, non-anti-depressant therapy for women experiencing symptoms of menopause,” said Debra Duke, President, MenoGeniX. “Our hope is that MNGX-100 will serve as a valuable alternative for the 70 million women worldwide who seek therapy each year for their severe menopause-related symptoms.”
Prior to the current study, MenoGeniX completed a multicenter, double-blind, randomized, placebo-controlled Phase I clinical trial to evaluate the safety and effectiveness of MNGX-100 in treating hot flashes in 30 women with naturally-occurring or surgically-induced menopause. A single injection of MNGX-100 at time 0 resulted in a statistically significant reduction in hot flash frequency and severity for nearly three-weeks post-administration compared to placebo. Although there were too few subjects to be able to definitively address the effect of MNGX-100 in patient sub-groups, data at two weeks suggested that women with surgically-induced menopause and those of African American descent responded particularly well, two sub-groups known to be most symptomatic.
Dr. Nanette Santoro, Chair of the Department of Obstetrics and Gynecology at the University of Colorado School of Medicine and Co-Principal Investigator on the SBIR grant, stated, “I’m excited to have the opportunity to develop a new therapy for my patients, many of whom are looking for alternatives or are unable to take hormones or anti-depressants, the only currently FDA-approved treatment options for hot flashes.”
MenoGeniX is currently seeking industry partnership opportunities and further funding for this potential new treatment for menopausal hot flashes and related symptoms.