Study will examine PhytoSERM, a natural approach to menopausal hot flashes, developed at the university.
Adapted from a story released by NeuTherapeutics, 10/10/23.
NeuTherapeutics, a Tucson startup founded to commercialize technology developed at the University of Arizona, has received a $2.5M Small Business Innovation Research (SBIR) grant from the National Institutes of Health/ National Institute on Aging (NIA) 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 the University of Arizona’s Clinical and Translational Sciences Research Center (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 hot flashes.
Developed by Dr. Roberta Diaz Brinton, director of the University of Arizona Center for Innovation in Brain Science and founder of NeuTherapeutics, PhytoSERM is a food supplement that contains three phytoestrogens. Phytoestrogens are naturally occurring compounds derived from plants that can function like the primary female sex hormone, estrogen. This natural therapy could provide relief for menopausal symptoms like hot flashes.
According to Dr. Brinton, “We developed PhytoSERM as a safe, natural, and effective approach for menopausal symptoms to address an unmet need in women’s health. 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 to address an unmet need in women’s health – relief of menopausal symptoms 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 hfrelief.org or call 520-254-7791. Enrollments in the trial will begin in early October.
NeuTherapeutics utilized key resources within the Tucson entrepreneurial ecosystem to secure the grant. University researchers are working with Tech Launch Arizona (TLA), the commercialization arm of the university, to bring PhytoSERM to the market, and had worked with TLA previously to strategize and form NeuTherapeutics, license other technologies, and complete the I-Corps customer discovery program.
"Securing this grant and moving into clinical trials is a huge accomplishment,” said TLA Director of Licensing and Intellectual Property Rakhi Gibbons. “We’re excited for Dr. Brinton and her team and are looking forward to a great future for NeuTherapeutics.”
The startup further advanced its business by joining the University of Arizona Center for Innovation (UACI), the university’s incubator network, working with subject matter experts on the commercialization plan required for the SBIR II grant application.
According to Dr. Brinton, “Award of this critical grant from the National Institute on 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.”