New Clinical Data Highlights Efficacy of Seed Health's VS-01 Vaginal Synbiotic in Establishing Protective and Optimal Vaginal Microbiome

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Aug 01, 2024, 08:07 ET

The study, which is the first to show that a multi-strain vaginal synbiotic can establish a protective vaginal environment, will be presented at the Annual Meeting of the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG)

The data demonstrate that VS-01™ successfully cultivates a vaginal microbiome dominated by Lactobacillus crispatus, reduces harmful microbes, and combats vaginal dysbiosis

These results underscore the potential of the vaginal microbiome and microbiome-directed innovations to redefine standards of care in women's health

BOSTON, Aug. 1, 2024 /PRNewswire/ -- Seed Health will present new clinical data on its flagship vaginal microbiome innovation, VS-01™ Vaginal Synbiotic, at the upcoming 2024 Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting. Data from a randomized, placebo-controlled clinical trial demonstrated the superior efficacy of VS-01™ in cultivating a stable and healthy vaginal microbiome. The synbiotic successfully established a protective environment dominated by Lactobacillus crispatus and inhibited harmful microbes associated with vaginal dysbiosis and inflammation. These findings highlight the transformative potential of proactive, preventive care centered on the vaginal microbiome, shifting the focus from traditional symptom management to maintaining a balanced and resilient vaginal ecology.

A landmark 2012 study from vaginal microbiome researcher Jacques Ravel, Ph.D., demonstrated that the most stable and optimal vaginal microbiome is characterized by a dominance of the bacterium Lactobacillus crispatus, which plays a protective role in maintaining vaginal health. However, everyday factors such as menstruation, sexual activity, exercise, stress, contraceptives, and cleansers can deplete the abundance of L. crispatus, leading to dysbiosis and related gynecological, urogenital, and obstetric conditions. Despite this, there have been no consumer innovations nor microbiome-directed solutions clinically validated to cultivate this optimal vaginal ecology.

"Over more than two decades of research, we have elucidated the critical role of Lactobacillus crispatus in maintaining a protective and stable vaginal microbiome and identified specific strains that are particularly effective at promoting vaginal health," explained Dr. Jacques Ravel, lead researcher. "VS-01™ was formulated using a consortia design with three proprietary strains of L. crispatus to successfully establish an L. crispatus-dominant vaginal microbiome, marking a significant milestone in the field and advancement for women's health."

"VS-01™ was developed to set a new standard in vaginal care," stated Sheri Simmons, Ph.D., VP of Discovery at Seed Health. "Our latest clinical findings underscore the potential of proactive care centered on the vaginal microbiome. By modulating the vaginal ecology, VS-01™ offers a new approach to support long-term vaginal health." Dr. Simmons will lead the presentations of two abstracts on VS-01™ at IDSOG.

IDSOG Presentation Highlights

Oral Presentation: A Novel Multi-strain Vaginal Synbiotic is Effective in Optimizing the Vaginal Microbiome: Results from a Randomized, Placebo-controlled Clinical Trial

Date and Time: Thursday, August 1 at 10:45 AM PT

This clinical trial evaluated the efficacy of VS-01™ in optimizing the vaginal microbiome. Key findings include:
- Established an Optimal Vaginal Microbiome: 90% of participants using VS-01™ established an optimal vaginal microbiome dominated by L. crispatus within 21 days of use, compared to only 11% in the placebo group (p<0.002).
- Advanced Delivery Technology: Seed's proprietary VS-01 SMART Tablet™ has an extended-release profile, which demonstrated superior conversion to an L. crispatus-dominant vaginal microbiome compared to all other formats: placebo, a fast-release vaginal capsule with the same strains, an oral format with the same strains, and a leading oral probiotic for vaginal health.
- Non-Efficacy of Oral Probiotic for Vaginal Health: The VS-01™ suppository tablet rapidly increased the abundance of L. crispatus in the vaginal environment. In contrast, no strains from a leading oral probiotic for vaginal health were detected in the vagina by the end of the study.
  
  This study is the first to demonstrate that a multi-strain vaginal synbiotic can establish a protective vaginal environment.

Poster Presentation: A Novel Multi-strain Vaginal Synbiotic is Effective in Inhibiting Microbes Associated with Vaginal Dysbiosis, Inflammation, and Mucus Barrier Degradation

Date and Time: Friday, August 2 at 1:30 PM PT

This study assessed the impact of VS-01™ on vaginal dysbiosis, inflammation, and mucus barrier integrity. Key findings include:

- Lowered Inflammation: VS-01™ significantly reduced the levels of the inflammatory cytokine IL-1alpha.
- Reduction in Harmful Microbes: VS-01™ demonstrated a significant reduction in Candida spp. and Gardnerella. Specifically, the mean abundance of Candida spp. was significantly lower in the VS-01™ arm compared to placebo at Day 21 (p=0.041). The abundance of Gardnerella significantly decreased in the VS-01™ arm from baseline to Day 21 (p=0.013).
- Inhibition of Pathogens and Pathobionts: VS-01™ reduced levels of microbes associated with vaginal dysbiosis, suggestive of colonization resistance.
- Decrease in Mucin-degrading Genes: Treatment with VS-01™ resulted in a notable decrease in mucin-degrading sialidase genes, suggesting an improvement in the protective mucus barrier.
  
  These findings suggest that VS-01™ effectively inhibits harmful microbes and supports the vaginal mucosal barrier, fostering an optimal and protective vaginal environment.

These presentations will detail the methodology and results from the two clinical abstracts, underscoring the transformative potential of microbiome science to enhance women's health and well-being.

"The data presented at IDSOG showcases the rigorous scientific approach we bring to probiotics and microbiome-directed solutions," stated Dirk Gevers, Ph.D., Chief Scientific Officer at Seed Health. "By evaluating biomarkers of vaginal health and conducting deep microbiome sequencing, we have validated the clinical benefits of VS-01™ to clearly distinguish it from other vaginal health solutions."

About Seed Health

Seed Health is a microbiome science company pioneering innovations in probiotics and living medicines to impact human and planetary health. Founded to realize the potential of the microbiome, our platform enables the translation of breakthrough science across a portfolio targeting health outcomes from infancy to aging. Our consumer innovations are commercialized under Seed®, an award-winning, science-first brand known for clinically validated innovations in probiotics, including DS-01® Daily Synbiotic and PDS-08® Pediatric Daily Synbiotic. Our pipeline encompasses both indication-specific and preventive applications for gastrointestinal and digestive health, women's health, skin, pediatrics, brain health, metabolic function, and healthy aging. Our environmental research is conducted under SeedLabs, which was founded to advance novel bacterial interventions to enhance biodiversity and restore ecosystems impacted by human activity.

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SOURCE Seed Health