When Luca Biologics began operations this spring, it was a startup in name only, since its co-founders had been collecting laboratory data on women’s health for nearly two decades. 

Armed with that research, Luca is ready to develop biotherapies that may help fill some of the voids in women’s health treatments, with a novel approach that starts at the biome level.

For the past 15 years, Dr. Jacques Ravel, the Associate Director for Genomics at the Institute of Genome Sciences at the University of Maryland School of Medicine and now Luca co-founder and chief scientist, has been compiling research on the vaginal microbiome from more than 1,500 women. A biome describes the microorganisms that exist in the vagina and throughout the body. 

The result is a new approach to treating pervasive women’s health problems, including infectious disease, reproductive medicine, and gynecology. Even the company’s name, Luca — meaning “Last Universal Common Ancestor” — is designed to be a nod to biology’s collective material lineage. Rather than attack bacteria with antibiotics that could do more damage to a woman’s body, Ravel and his team at Cambridge, Massachusetts-based Luca are developing microbiota-based drugs that will restore and protect the vaginal microbiome. 

The first drug in the pipeline is designed to treat urinary tract infections, particularly recurring cases. 

Meeting An Unmet Need

Initial investors were shocked by the lack of drugs addressing a problem affecting so many women, Raja Dhir, a Luca co-founder and board chairman, told Karma. Dhir is also co-CEO and co-founder of Seed Health, an accelerator that supported Luca. 

The need has become particularly pressing since the FDA revised its stance on certain antibiotics that doctors recommended for UTIs. The agency found that fluoroquinolones could lead to “disabling side effects” involving tendons, muscles, nerves and joints. 

“The lack of a large-scale, cost-effective, and durable persistent intervention is just mind-boggling,” Dhir said. Luca “is that unique investment that breaks down the boundary between impact investment and investor ROI.” 

“It’s not purely philanthropic,” Dhir said. “There’s an unmet medical need that affects 10 million women in the U.S. alone, so there is an opportunity for profit.” 

To be sure, predicting if Luca’s therapeutics will be effective is difficult since the company is operating in a new research area. Additionally, even if their solutions are effective, the medical establishment doesn’t always immediately embrace change. 

“Microbiome therapies in general have just not lived up to the hype,” said biotech investor Wilson Cheung. “If their first target is recurrent UTI the data is going to have to be stellar.”

Not Just a Microbiome Moment

Luca’s launch comes as medical professionals and amateurs are proselytizing about the microbiomes’ importance in human health. 

Dhir said that Luca’s work with the vaginal microbiome is better suited to produce safe and effective solutions than other microbiome-related therapies. 

He noted that the gut microbiome is made up of hundreds of different species, and the medical community’s understanding of how each of those affect overall health is limited and a treatment that seems effective now could lead to unintended consequences. The vaginal biome, he says, is typically dominated by one of only a handful of different species. That allows Luca to target its research and allow for greater insight into potential long-term effects of their therapies. 

“We were able to do extensive safety profiling and track the persistent long-term effects in a wide-ranging population, in a way that is much more difficult to do when looking at the gut,” Dhir said. 

Ravel tracked some women for 10 years. “That gives us a safety and efficacy profile that is unparalleled to date,” Dhir said.  

Still Up for Trials

Luca’s first product, for UTIs, will enter Phase 1b clinical trials this year. Harvard Medical School faculty will lead the trials, being held at Boston’s Massachusetts General Hospital. In the near future, the team will work on therapeutics for conditions including bacterial vaginosis and preterm birth.The opportunity to reverse some of the sobering statistics about women’s health and be part of a burgeoning biotech industry poised to hit $775 billion by 2024 may be in Luca’s future. And the impact wouldn’t be just among women. In addition to directly impacting everyone via birth, women’s health indirectly impacts families and workplace productivity when undiagnosed, poorly treated, or ignored illnesses sideline women.