News
Biotech start-up reports positive clinical trial results for vaginal dysbiosis therapy
The data is hoped to allow Freya to expand its clinical activities and support the IVF population with vaginal dysbiosis
The women’s health biotech start-up Freya Biosciences has announced positive results from a clinical study of its investigational vaginal microbial treatment.
A clinical-stage company, Freya aims to take an innovative approach to women’s health by using microbial immunotherapies to relieve the chronic inflammation underlying a range of reproductive system diseases afflicting women.
The Phase 1 clinical study, conducted in Europe, was a randomised, double-blind, placebo-controlled trial and evaluated the change in vaginal microbiome of its investigational vaginal microbial immunotherapeutic, FB101, in women with asymptomatic vaginal tract dysbiosis – a situation whereby the vaginal microbiota experiences a reduction in the predominant population of lactobacillus.
Results demonstrated dysbiosis resolution by a rapid switch from a dysbiotic to a lactobacillus-dominated vaginal microbiome after administration of FB101 that was sustained for over eight weeks.
Furthermore, the trial showed that engraftment of the FB101 lactobacilli species was established in half of the women. A change in inflammatory markers was also found.
Asymptomatic vaginal dysbiosis is a common finding in women undergoing IVF and can have detrimental implications on treatment success.
Joan-Carles Arce, chief medical officer of Freya, said: “Data from a cohort study conducted in collaboration between Freya and a major US clinic, Boston IVF, supports the concept of lower pregnancy rates in women with a dysbiotic inflammatory vaginal microbiome compared to women without this condition when undergoing IVF.
“We look forward to advancing the clinical development program with FB101, which has the potential of becoming the first targeted therapy for the IVF population with vaginal dysbiosis.”
Colleen Acosta, CEO of Freya Biosciences, said: “We are very encouraged by the promising Phase 1 results of our lead candidate, FB101, and are incredibly proud of our team and clinical partners for enabling this milestone.
“The initial results additionally give strength to our platform and lay the groundwork for further pipeline programs with Freya’s immunotherapeutic candidates for other conditions within the women’s health area.”
Freya intends to study FB101 for improving fertility outcomes and enhancing the success rates of IVF. Initial results will be shared by Johan van Hylckama Vlieg, chief scientific officer of Freya Biosciences at the Microbiome Movement Summit in Boston later this month.
The data is hoped to allow the company to expand the clinical activities with its lead asset FB101 to help women seeking infertility treatment and undergoing IVF.
The World Health Organization (WHO) has launched an AI tool in beta to help policymakers, experts and healthcare professionals access sexual and reproductive health information faster.
Called ChatHRP, the tool was created by WHO’s Human Reproduction Programme and draws only on verified research and guidance collected by HRP and WHO.
It uses natural language processing and retrieval-augmented generation to produce referenced content and cut the time spent searching through documents across different platforms and databases.
WHO said ChatHRP also has multilingual capabilities and low-bandwidth functionality to support use in a wide range of settings.
The beta-testing phase is aimed at a broad professional audience, including policymakers, healthcare workers, researchers and civil society groups.
WHO said the tool can help users quickly access up-to-date evidence, find sources for academic work and verify information on sexual and reproductive health and rights.
Examples of questions it can answer include the latest violence against women data in Oceania for women aged 15 to 49, recommendations on managing diabetes during pregnancy, and whether PrEP and contraception can be used at the same time. PrEP is medicine used to reduce the risk of getting HIV.
WHO added that the system will be updated regularly as new HRP materials are published and includes a feedback loop so users can flag gaps in the information provided.
The launch comes amid wider concern about misinformation in sexual and reproductive health.
A 2025 scoping review found that misinformation in digital spaces is a systemic issue that can undermine human rights, reinforce discriminatory social norms and exclude marginalised voices.
The review also said misinformation can affect health systems by shaping provider knowledge and practice, disrupting service delivery and creating barriers to equitable care.
WHO said ChatHRP is intended to give users streamlined access to reliable information as a counter to “algorithms, opinions, or misinformation”.
Wellness
Women’s HealthX unveils Northwell Health, Corewell Health, Biogen & more to headline Chronic Disease stage
Women’s HealthX has announced its lineup of healthcare trailblazers speaking on Chronic Disease Management, alongside other specialisations including Fertility, Sexual Health, Maternity, Menopause and Cognitive Health, taking a holistic approach to women’s health.
It will bring together 750+ leaders across pharma, health systems, and innovation to address one of the most urgent and underexamined challenges in healthcare; the sex difference gap in data and evidence.
Since cardiovascular disease remains the leading cause of death among women globally, and autoimmune and neurological conditions affect women at significantly higher rates, Women’s HealthX will home in on chronic disease management with 17+ sessions spotlighting case studies and lessons learned.
The Chronic Disease Management Stage at Women’s HealthX responds directly to this gap, convening senior decision makers and innovators to explore how sex specific science, digital health, and new care models can reshape outcomes for women.
Attending pharma & healthcare organisations include:
- Tracy Sims, Executive Director, Cardiometabolic Health, Eli Lilly
- Adrian Kielhorn, Senior Director, Global Head HEOR Neurology, Alexion Pharmaceuticals
- Lauren Powell, Head of Health Equity and Clinical Innovation, Biogen
- Amy Kao, SVP, Head of Neuroscience and Immunology Research, EMD Serono
- Stella Vnook, Executive Chair and CEO, Kaida Biopharma
- Amanda Borsky, Director, Clinical Research, Northwell Health
- Lacey McIntosh, Division Chief, Oncologic and Molecular Imaging, UMass Memorial Medical Center
- Nicole Turck, Vice President Operations, Women’s Health, Corewell Health
- Mette Dyhrberg, CEO, Autoimmune Registry
- Lyn Agostinelli, Principal Consultant, Halloran Consulting Group
Sessions addressing the real gaps in women’s chronic care
The agenda features a series of high impact sessions tackling the structural and scientific gaps in women’s health:
- Improving outcomes in obesity through evidence based person centered care: Eli Lilly
- Tackling sex based health inequities by breaking down barriers and bias: Alexion Pharmaceuticals
- Close the health equity gap in women’s health by improving how autoimmune diseases are diagnosed, treated and managed: Autoimmune Registry
- How a GYN only care model is driving faster access to gynecological care: Corewell Health
- Transforming early detection in ovarian cancer: new pathways to accuracy, safety, and better outcomes: UMass Memorial Medical Center
Panel discussions include:
- Why chronic disease looks different in women and why health systems haven’t adapted: Biogen, Kaida Biopharma, EMD Serono
- How can we better engage with our customers: Northwell Health, Halloran Consulting Group
Health equity starts here. REGISTER YOUR PLACE
Why This Matters Now
Women’s HealthX positions chronic disease not just as a clinical challenge, but as a critical frontier for innovation, investment, and system redesign.
From AI powered monitoring and digital therapeutics to real world data and integrated care pathways, the stage highlights where meaningful progress is already being made and where the biggest opportunities lie.
For the FemTech ecosystem, this represents a pivotal moment: aligning technology, clinical insight, and commercial strategy to finally close the long standing data and care gaps in women’s health.
About Women’s HealthX
Women’s HealthX is where the transformation of women’s health begins at its true foundation: data, science, and evidence.
It’s the leading event dedicated to closing the sex difference data gap and accelerating breakthroughs through science driven, real world case studies.
Taking place on December 3 to 4, 2026 in Boston, USA, the exhibition will bring together more than 750 healthcare leaders, including clinicians, payers, employers, investors, and policymakers.
Seven different stages with 150+ expert speakers taking an holistic approach to women’s health. From fertility, maternity, sexual health, cognitive health, menopause and chronic disease, we address care at every stage of a woman’s life.
An AI atlas has mapped how reproductive organs age through menopause, with the ovaries, vagina and uterus changing on different timelines.
To better understand how this process affects health, researchers at the Barcelona Supercomputing Center developed what they describe as the first large-scale atlas of female reproductive system ageing, using artificial intelligence.
The team combined 1,112 tissue images from 659 samples, covering 304 women aged 20 to 70, with gene expression data from thousands of genes.
This allowed them to reconstruct how seven key reproductive organs, including the uterus, ovary, vagina, cervix, breast and fallopian tubes, age over time.
The study used the supercomputing power of MareNostrum 5 together with advanced image-recognition methods to process the data.
Using deep learning techniques, the researchers detected visible tissue changes as well as the underlying molecular processes linked to ageing in each organ.
The result was a detailed, organ-by-organ map of the reproductive system’s ageing process.
The researchers found that not all organs age in the same way or at the same speed. The ovaries and vagina showed a more gradual ageing process that begins even before menopause officially starts.
By contrast, the uterus appeared to undergo more sudden changes around the time of menopause.
Even within a single organ, different tissues aged at different rates. In the uterus, for example, the mucosa, its inner lining, and the muscular layer did not change in sync. These tissues also appeared to be particularly sensitive to the hormonal and biological shifts associated with menopause.
Marta Melé, leader of the transcriptomics and functional genomics group at BSC and director of the study, said: “Our results show that it acts as a turning point that profoundly reorganises other organs and tissues of the reproductive system, and allows us to identify the genes and molecular processes that could be behind these changes.”
Building on the finding that organs age according to different patterns, co-first author Laura Ventura said the research “paves the way for personalised medicine where treatments are tailored to a woman’s specific molecular profile and the specific tissues showing the most age-related distress.”
The study also identified molecular signals linked to reproductive ageing that can be detected in blood samples from more than 21,441 women.
These biomarkers could allow doctors to monitor the condition of reproductive organs in a non-invasive way, potentially helping to anticipate risks such as pelvic floor complications without the need for biopsies.
According to the researchers, this could lead to simpler and more accessible clinical tools for tracking women’s health over time.
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