UArizona Startup NeuTherapeutics Wins $2.5 Million Grant
NeuTherapeutics, a Tucson startup founded to commercialize University of Arizona technology has received a $2.5 million Small Business Innovation Research grant from the National Institutes of Health/National Institute on Aging to conduct a Phase 2 clinical trial to evaluate the impact of a new dietary supplement, PhytoSERM, on menopausal hot flashes in women.
Launching this October, this Phase 2 SBIR grant will support the HF Relief Clinical trial with more than 100 participants at UArizona’s Clinical and Translational Sciences Research Center, or CATS. The clinical trial follows a successful previous double-blind, placebo-controlled Phase 1b/2a clinical trial in 72 women that found that PhytoSERM was safe and well-tolerated, and decreased the number of hot flashes in women experiencing large numbers of them.
Developed by Dr. Roberta Diaz Brinton, founder of NeuTherapeutics, and director of UArizona Center for Innovation in Brain Science, PhytoSERM is a food supplement that contains three phytoestrogens. Phytoestrogens are naturally occurring compounds derived from plants that function like the primary sex hormone–estrogen. This natural therapy could provide relief for menopausal symptoms like hot flashes.
“We developed PhytoSERM as a safe, natural and effective approach for menopausal symptoms to address an unmet need in women’s health,” said Brinton. “Many women going through menopause experience symptoms, like hot flashes, which can disrupt their daily routines and sleep patterns. Unfortunately, many women will endure menopausal symptoms without seeking symptom relief because of a fear of breast cancer. PhytoSERM is the culmination of decades of rigorous, independently evaluated research that promotes both brain and breast health.”
The clinical trial is recruiting 132 healthy women with menopause-related hot flashes between the ages of 45 and 60 for a 30-week study. The first half of the study will be randomized, double-blinded and placebo-controlled, while in the second half of the study all women will receive PhytoSERM.
Women experiencing hot flashes that disrupt their lives and are not currently utilizing hormone replacement therapy or other prescription treatments for hot flashes are eligible to participate in the clinical trial and will receive compensation. Women interested in participating can visit www.hfrelief.org or call (520) 254-7791. Enrollment in the trial will begin in early October.
NeuTherapeutics utilized key resources within the Tucson entrepreneurial ecosystem to secure the grant. University researchers worked with Tech Launch Arizona, the commercialization arm of the university, to protect the intellectual property, strategize, form NeuTherapeutics, and complete the I-Corps customer discovery program. NeuTherapeutics advanced their business by joining the University of Arizona Center for Innovation, the university’s incubator network, working with subject matter experts on the commercialization plan required for the SBIR 2 grant application.
“Award of this critical grant from the National Institute of Aging would not have been possible without the support of the entire U of A entrepreneurial ecosystem. UACI and TLA have been critical in propelling NeuTherapeutics forward. Having traveled the country speaking with other academic innovators, I can say that the University of Arizona’s support for startups is second to none.”
Pictured above from left – The HF Relief Clinical Trial Team: Madison Chiodi, Dr. Roberta Brinton of NeuTherapeutics and Dr. Gerson Hernandez and Claudia Lopez of the University of Arizona
