Urinary tract infections are among the most common bacterial infections in the United States, but treatment options are shrinking as resistance to antibiotics commonly prescribed to treat the condition continues to rise.
Luca Biologics, a new Cambridge, MA-based biotech focused on women’s health, emerged Tuesday with a plan to advance an investigational UTI drug into human testing in the next year, along with others addressing common women’s health conditions. About half of all women will develop UTIs in their lifetimes.
The company’s name is a nod to what’s known as the “last universal common ancestor”—the microbial life form to which all life on Earth today can trace their origins. The compounds that Luca is developing are based on years of research conducted by microbiome expert Jacques Ravel, Luca’s chief scientific officer.
Interest in developing drugs that alter interactions between our bodies and the trillions of microorganisms that live in and on it, together known as the human microbiome, has risen in recent years. But most of the attention to date has been paid to ailments affecting the gut biome, such as Clostridium difficile infection, according to Luca co-founder Raja Dhir.
“It’s a large interface between genetic factors, environmental factors, dietary and lifestyle factors that all kind of confound that environment. … Other than some very promising early work on C.diff infection, it’s been hard to translate some of those findings into FDA-approved therapeutics that really can have reproducible efficacy across a wide-ranging population,” Dhir said. “We’re excited to move beyond [the gut] to these areas where microbes have an equally important role.”
Ravel, a professor of microbiology and immunology at the University of Maryland and an associate director of genomics at the UMD’s Institute for Genome Sciences, runs a lab that studies the role of the vaginal microbiome in women’s health. He is also a leading scientist with the National Institutes of Health’s Microbiome Project, and his research has helped identify strains capable of affecting the vaginal and urogenital microbiome, according to Luca.
Luba Greenwood, who most recently served as business development manager at Verily, the biotech arm of Google’s parent company, Alphabet (NASDAQ: GOOGL), is also a co-founder of Luca. Greenwood previously worked at Roche as vice president of global business development and mergers and acquisitions.
The company, which has about 20 employees, says that addition to starting clinical trials to study its investigational treatment for UTI, sometime next year it plans to start human testing of experimental therapies for bacterial vaginosis (BV), a common infection among women of reproductive age that can increase their risk of contracting sexually transmitted diseases, and for preterm birth. About 10 percent of babies in the US in 2017 were born too early, according to the Centers for Disease Control; preterm labor can lead to pregnancy complications, and increases the risk of the baby’s death or serious disability. Luca is also working on a treatment for infertility, the company said.
The biotech is the first startup to emerge from Seed Health, an incubator of sorts that is working with scientists doing microbiome research to accelerate the translation of their efforts into medicines. The effort is an arm of Seed, a Los Angeles microbiome science company that Dhir co-founded with Ara Katz in 2015. Seed sells probiotic supplements to consumers. Luca’s work is being financed through academic partnerships and $2.8 million from Seed Health, according to the company.
It’s still early days for women’s health companies: While funding activity looks to be ramping up, most of the deals in recent years were seed or Series A investments, according to research firm CB Insights. And with the investment community skewing heavily male, some entrepreneurs say that those in a position to fund women’s health startups may not understand the nature of the concerns being addressed—or even realize it exists. While so-called femtech, or companies developing digital health tools developed to address women’s health needs, have recently captured investor interest, many life sciences funders continue to put capital toward the development of drugs that affect a relatively small number of patients, but command hefty price tags.
Treatments for common conditions such as those Luca plans to tackle, which can significantly impact women’s quality of life and lead to other health issues, haven’t been improved for years. But Dhir says Luca believes the historical underfunding of women’s health startups is more a matter of perspective than financial realities.
“If there are conditions that affect a very large percentage of the population, then to recover R&D costs you don’t have to have very expensive treatments if you’re serving a lot of patients,” Dhir says.
Seed Health, he says, aims to lessen the obstacles to starting such companies by leveraging its academic partnerships to help scientists protect their intellectual property, scale biofermentation efforts, and launch clinical trials.