In the rapidly evolving realm of women’s health, few topics have garnered as much attention and intrigue as the vaginal microbiome and precision nutrition clinical trials. As new research paves the way for innovative solutions to age-old challenges, Femmistry stands at the forefront, offering a unique blend of hormonal health, femtech, and precision nutrition.
In this exclusive interview, we sit down with Malcolm Bohm, a seasoned expert in the field of women’s health, to delve deep into the clinical trials he’s conducted, Femmistry’s unique approach to precision nutrition, and the company’s broader mission. From the intricacies of the vaginal microbiome to the integration of at-home testing in decentralized clinical trials, Bohm shares valuable insights that offer a fresh perspective on the future of women’s health.
Moe Alsumidaie: Malcolm, given your extensive experience in Women’s Health, could you describe the clinical trials you’ve conducted, especially those centered on the vaginal microbiome, and how you approached collecting and analyzing data related to women’s symptoms and hormonal status?
Malcolm Bohm: We’ve run a couple of clinical trials looking specifically at the vaginal microbiome in terms of sample collection and subsequent analysis. We’ve been involved in trials where we’re recruiting women to provide information about their symptoms, current status, and subsequent analysis of their hormones, correlating that to the status of the vaginal microbiome.
Moe Alsumidaie: With Femmistry’s emphasis on precision nutrition, particularly regarding perimenopausal women, how do you anticipate the impact of precision nutrition on the varied symptoms and hormonal imbalances they experience?
Malcolm Bohm: For Femmistry, the plan revolves around trials that examine whether precision nutrition can fully ameliorate some of the symptoms that perimenopausal women suffer. Hormones impact many systems. We’re exploring the effects of precision nutrition versus hormone replacement, focusing on understanding blood work and precision supplementation and nutrition plans for these women.”
Moe Alsumidaie: Clinical trials often focus on specific endpoints to determine the efficacy of interventions. In the context of Femmistry’s trials, which endpoints are pivotal to gauge the impact of your interventions on perimenopausal women?
Malcolm Bohm: Endpoints include whether women can achieve weight loss, the frequency and severity of hot flashes, mood swings, and brain fog. We’re developing a questionnaire to validate changes in these symptoms.
Moe Alsumidaie: Decentralized clinical trials offer the advantage of reducing patient burden by eliminating site visits. How does Femmistry approach the integration of at-home testing, particularly blood tests, in its trial design?
Malcolm Bohm: From a decentralized trial perspective, it’s more sensible not to have trial site visits for tasks patients could do at home. We’ve chosen an at-home blood test with hormone levels, blood chemistry, and genomic markers. We aim to understand if there’s an epigenetic component related to estrogen receptors in women.
Moe Alsumidaie: Femmistry appears uniquely positioned in the clinical trial landscape, blending hormonal health, femtech, and precision nutrition. Could you elaborate on how you envision Femmistry’s role and categorization in this realm?
Malcolm Bohm: We initially identified as a hormonal health company, but it’s broader than that. Femmistry is a women’s health company, a femtech company, and a precision nutrition company. We focus on rebalancing women’s chemistry at a hormonal level and micro and macronutrients.
Moe Alsumidaie: The primary goal of Femmistry’s clinical trials seems to be generating robust clinical data rather than seeking regulatory approval. How does this approach align with Femmistry’s broader mission and interactions with healthcare professionals?
Malcolm Bohm: Our objective isn’t regulatory approval but to produce robust clinical data for healthcare professionals. Managing women’s hormones is critical. We aim to work with healthcare professionals, ensuring our data is clinically robust and statistically relevant for adoption.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.