MenoGeniX Awarded NIH Grant to Fund Phase Ib/IIa Clinical Trial

Funds will support a potential new approach to treating women with menopausal symptoms

AURORA, Colo., May 3, 2018 /PRNewswire/ -- MenoGeniX, an Aurora-based biotech company focused on women’s health, announced today 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. For more information, visit www.menogenix.com.

About MNGX-100
MenoGeniX is committed to developing MNGX-100 to provide a potential alternative therapy for women with either naturally-occurring or surgically-induced menopause who suffer from moderate or severe hot flashes and other vasomotor symptoms. MNGX-100 contains a naturally-occurring human protein called G-CSF, also known as granulocyte colony-stimulating factor. This cytokine (a cell signaling molecule) stimulates the production of neutrophils, a type of white blood cell. MenoGeniX believes that G-CSF is acting on the hypothalamus, the body’s thermostat, to counteract the effect of proinflammatory cytokines that are often elevated in individuals experiencing menopausal symptoms. MenoGeniX’s initial clinical trial results strongly suggest that MNGX-100 will be well-tolerated and will lead to a durable reduction in hot flash frequency and severity.

About Menopause
Menopause is the end of female fertility, occurring 12 months after a woman’s last menstrual period. On average, naturally-occurring menopause occurs around age 52, although vasomotor symptoms can start much earlier. Premature menopause can also happen at any age as the result of surgery (i.e. oophorectomy - removing both ovaries). Over 10 million women in the U.S., aged 50-65, experience hot flashes due to naturally-occurring menopause. Roughly half have symptoms severe enough to seek medical treatment. Vasomotor symptoms of menopause include: hot flashes, night sweats, vaginal dryness, joint pain, sleep problems, mood changes, weight gain and slow metabolism, thinning hair and dry skin.

About MenoGeniX
MenoGeniX, a clinical-stage biotech company focused on women’s health, is committed to developing MNGX-100, an alternative to FDA-approved hormone therapies and anti-depressants to treat hot flashes and related vasomotor symptoms of naturally-occurring and surgically-induced menopause. To learn more, visit www.menogenix.com or contact info@menogenix.com.

Disclaimer: Research reported in this press release was supported by the NIA of the NIH under award number 1R43AG056209-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Media Contact:
Courtney Megaughey
PR Coordinator
CSSi LifeSciences
(443) 308-5831
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Investor Contact:
Debra Duke
President
MenoGeniX
(303) 995-7979
194369@email4pr.com