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Company Forms to Treat Vaginal Microbial Disorders

Lactobacillus

Lactobacillus acidophilus bacteria, considered a “friendly” vaginal microbe, shown in scanning electron microscope image (Mogana Das Murtey and Patchamuthu Ramasamy, Wikimedia Commons)

6 Aug. 2019. A new enterprise has launched to develop live microbial treatments for urinary tract infections and other diseases originating in vaginal bacterial communities. Luca Biologics in Cambridge, Massachusetts is formed by Seed Health, the science commercialization and start-up accelerator arm of the Seed community, a developer of microbiome-related products.

Luca Biologics is designing treatments for urinary tract infections and bacterial vaginosis, a condition that increases the risk of pre-term birth. Urinary tract infections can occur in both sexes, but happen most often in women. If left untreated, these infections can spread to the kidneys or beyond with serious consequences. National Kidney Foundation says urinary tract infections are responsible for some 10 million doctor visits a year in the U.S., with at least 1 in 5 women likely to have an infection in her lifetime.

Bacterial vaginosis is an inflammatory disorder that results from an overabundance of anaerobic bacteria that upset the natural microbial balance in the vagina. The company cites data showing as many as half of all women are affected by bacterial vaginosis, resulting in higher risks of sexually transmitted diseases and pregnancy complications, including pre-term birth.

Unlike conventional treatments based on antibiotics, Luca Biologics plans to develop a pipeline with live microbes that the company says protect, sustain, and restore the functioning of natural microbial communities in the vagina. The company’s technology is based on research by microbiologist Jacques Ravel at University of Maryland medical school in Baltimore. Ravel’s lab studies microbial communities in the vagina to better understand the composition of those communities including their genomic properties, and develop models to better predict growth and development of vaginal microbes, including disease states and treatment options.

“There is an urgent need for innovation in women’s health,” says Ravel in a Seed Health statement released through PR Newswire. “While our research started with metagenomic sequencing to generate large comparative data sets, we can now translate our findings into safe and effective treatments for widespread conditions that stigmatize and devastate millions of women each year.”

Ravel is a co-founder of the company and serving as its chief scientist. Luca is gaining access to the Ravel lab’s library of more than 1,000 bacterial strains, related genes, and transcribed proteins. From this library, Luca identifies, isolates, and screens specific bacterial strains with therapeutic properties for development into treatments for urinary tract infections and bacterial vaginosis that restore a natural microbial balance in the vagina.

The company says its preclinical work so far resulted in biological therapy candidates for urinary tract infections and pre-term births about ready for investigational new drug applications to the Food and Drug Administration. If granted, they will authorize clinical trials of those treatments. Luca anticipates early-stage clinical trials for its urinary tract infection treatments to begin later this year.

Luca Biologics is the first company to emerge from Seed Health’s foundry, a start-up accelerator for companies developing microbiome-related therapeutics. Seed Health says the foundry provides scientists with capital investment, guidance on intellectual property and regulatory procedures, and biofermentation for manufacturing. Capital investment funds for Luca Biologics were not disclosed.

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