Biotech startup joins quest to harness microbiome to untether reliance on antibiotics in women's health
Harnessing data gathered as part of the National Institutes of Health (NIH) Human Microbiome Project, the co-editor-in-chief of the journal Microbiome, Jacques Ravel, has formed a biotechnology company focused on women’s health.
The company, christened Luca Biologics, has leaned on 15 years of Ravel’s vaginal microbiome research to develop a pipeline of therapeutics designed to treat urinary tract infections (UTI), preterm birth and bacterial vaginosis.
The WHO estimates that UTIs impact half of all women, and is the most common bacterial infection in the United States. Antibiotics are the first and only line of defense, but drug resistance has burgeoned and superbugs are all-pervasive. But the path to antibiotic approval is long, arduous and expensive — it offers little financial gain as treatments must be priced cheaply, and often lose potency over time as microbes grow resistant to them. Meanwhile, doctors prefer to use older, infinitely cheaper antibiotics in their first response, reserving fresh alternatives for acute cases. Consequently, there has been no new class of antibiotics approved since the 1980s — and today, roughly 700,000 deaths annually are attributed to drug-resistant bacteria, according to the WHO. Meanwhile, the industry players contributing to the arsenal of antimicrobials are fast dwindling as feeble sales frustrate growth.
However, last month the FDA sanctioned the approval of Merck’s $MRK combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.
Luca’s microbiome-derived UTI trial is expected to begin enrolling patients this fall.
Luca’s pipeline emerged from a vaginal microbiota library of 1,000+ strains and gene catalog assembled by a research group led by Ravel and funded by the NIH and the Bill and Melinda Gates Foundation. That data were screened to isolate genes that maintain and protect the stability of vaginal communities over time — and those insights were used to develop experimental compounds.
“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 said in a statement.
Microbial sciences company Seed Health, which counts Harvard geneticist George Church and Ravel on its scientific advisory board, spawned Luca as part of its mission to develop microbial therapies for conditions that are underserved by current standard-of-care. Seed Health partners with scientists to provide capital investment, regulatory and IP guidance, bio-fermentation scale-up, and assistance with clinical trials through its academic partnerships.
Microbiome-based therapeutics today is a fecund field for drug developers — big and small — capitalizing on science that suggests flushing ‘good’ gut bacteria into the system can treat a plethora of conditions — from C. diff infections to obesity — using different therapeutic modalities, some of which are designed to sidestep the “ick” factor associated with traditional stool transfer or fecal microbiota transplantation (FMT).