Siolta is a QB3 incubator alum. Story by Ron Leuty in the San Francisco Business Times.
Working to identify risk factors for allergies and asthma, then-postdoctoral researcher Nikole Kimes spotted interesting microbial signatures: Babies who developed so-called atopic diseases appeared to lack specific bacteria in their guts that you'd find in most healthy infants.
Now Kimes' Siolta Therapeutics is deep in the throes of an early-stage clinical trial aimed at seeing if its powder-pill mix of bacteria — what's known as a live biotherapeutic product, or LBP — can reset infants' guts. If those keystone organisms work and the rest of the microscopic community develops as it should, she said, kids could be set on a healthier long-term path free of allergy-related chronic conditions.
The company's 264-child, 31-site ADORED study — a rough acronym for allergic disease onset prevention — hopes to close enrollment this fall. It expects to report interim data by the end of next year.
Allergies and the microbiome represent high-profile targets and approaches. The National Institutes of Health estimates allergic diseases in the United States hit about a third of kids. The microbiome and its complex interactions between organisms have been a popular jumping-off points for therapeutic startups over the past decade or more.
But developing a therapy that works specifically on a condition but broadly across a population has been easier marketed than scientifically done.
Siolta — the Gaelic word for "seed" — is taking a different path than many companies in the microbiome space. Some of those companies have sidestepped intensive and expensive human clinical trials to get their microbiome-based foods or supplements on store shelves as quickly as possible. Siolta is taking the traditional drug-maker approach, including the current double-blind, placebo-controlled Phase Ib/II study where infants' families and doctors don't know who's getting active drug and who's getting a fake.
"For us, it's really about answering the scientific question," Kimes said.
Other companies have pursued allergies from different angles and with different results. Menlo Park's Alladapt Immunotherapeutics Inc. in June said early data from its Phase I/II study of its oral immunotherapy, ADP-101, in children with multiple food allergies supported moving it into late-stage clinical development, for example. But a groundbreaking peanut allergy treatment from Aimmune Therapeutics of Brisbane faltered commercially and reportedly has led its owner, Nestlé SA, to look at selling the business.
Siolta's drug, called STMC-103H, is a concoction of naturally occurring bacteria balanced to be beneficial over the long term, said Kimes, who started Siolta in 2016 with Susan Lynch, her lab leader at the University of California, San Francisco. For infants, the pill can be broken open and its powder sprinkled into milk or baby formula.
The study has a limited window with its young enrollees. Those subjects have a genetic predisposition to developing antibodies to a variety of eaten or inhaled allergens. The substances perturb the immune system and force potentially serious acute reactions or long-term chronic diseases, such as the skin condition atopic dermatitis, food allergy, asthma and allergic rhinitis, or what's commonly known as hay fever.
The young, naive microbiome will grow quickly over the first year, Kimes said, so it is important to have the right balance of organisms that will desensitize them to the allergens' immune-hyping reactions.
There is no Food and Drug Administration-approved treatment to prevent atopic diseases.
"Because we are targeting at-risk infants — traditionally defined by familial history — the parents represent a motivated population," Kimes said. "They have either experienced the negative impact of these diseases themselves or with at least one of their previous children. They understand first-hand the toll a debilitating chronic disease can have on one's life."
Funding for the 12-person company, operating out of an MBC BioLabs incubator in San Carlos, includes a $30 million Series B round in fall 2020 that involved Khosla Ventures and Salesforce.com Inc. founder and CEO Marc Benioff.
Benioff's family also gave $25 million in 2019 to launch the Lynch-led UCSF Benioff Center for Microbiome Medicine.
"We're not trying to develop an expensive treatment," Kimes said. "We want clinicians providing or recommending treatment. It's hard for them to recommend off-the-shelf (products), because they don't hae the data to know if it's efficacious."