NeuTherapeutics, a Tucson startup founded to commercialize University of Arizona technology 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 II clinical trial to evaluate the impact of a new dietary supplement, PhytoSERM, on menopausal hot flashes in women.
Launching this September, this Phase II SBIR grant will support a 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.
Developed by Dr. Roberta Diaz Brinton, founder of NeuTherapeutics, and director of the University of Arizona Center for Innovation in Brain Science, PhytoSERM is a food supplement that contain 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 for a safe and effective alternative to estrogen therapy. 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 will recruit 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 a randomized, double-blinded and placebo-controlled trial which will be followed by second phase when 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. 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 (TLA), 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 (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 UArizona’s support for startups is second to none.”
About NeuTherapeutics:
NeuTherapeutics is an innovative neuroscience biotech company whose singular goal is to provide safe and effective regenerative treatments for the brain that roll back the impacts of neurodegenerative diseases, improving lifespan and quality of life for patients and their families. NeuTherapeutics brings decades of innovative research experience to our work that advances the treatments patients need today. Founded by Dr. Roberta Brinton, Director of the University of Arizona’s Center for Innovation in Brain Science, NT is currently developing Allopregnanolone as a treatment for Alzheimer’s and other neurodegenerative diseases as well as PhytoSERMs as a dietary supplement to alleviate temporary menopausal hot flashes.
