Bloom Science, a biotech founded to advance a new class of microbe-based therapeutics for neurological disorders, is making its debut today with the publication of research that suggests certain bacteria in the gut could be used to manage epileptic seizures.
The research, published in the journal Cell, indicate that several specific strains of bacteria work together in mice to provide neuroprotective effects against epileptic seizures.
By delivering these microbes in the gut, a scientific team led by the UCLA neurobiologist Elaine Hsaio said it could duplicate the protective benefits of the ketogenic diet, a treatment developed a century ago to manage epilepsy. The high-fat, low-protein diet (which is difficult to maintain over time) was developed in the 1920s, and is still used as a last resort for treating epilepsy in some patients who don’t respond to current anti-seizure medicines.
The Hsaio team’s insights have laid out a path for developing new microbial treatments for managing epileptic seizures that would not require a ketogenic diet. The goal of the treatment would be to cultivate a stable microbial community in the guts of epilepsy patients that could impart long-lasting anti-seizure effects without the need for continual treatments.
Bloom Science was founded in San Diego earlier this year to run with the microbial treatment idea. “The science was stellar. There was a clear signal,” said CEO Tony Colasin, who co-founded Bloom with Hsaio and Chris Reyes, the chief scientific officer. (Colasin and Reyes are pictured in top photo.) After raising seed capital from individual investors, the startup is laying plans for a formal venture round, Colasin said.
“We have a hundred years of experience with the ketogenic diet, but we didn’t really know why it works,” Colasin said. “The significance of the work published in Cell explains the key role the microbiome plays in this neuroprotective process.”
Hsaio’s identified several bacterial strains (Akkermansia muciniphila, Parabacteroides merdae, and P. distasonis) that are enriched by the ketogenic diet. The research also explains how these bacteria confer anti-seizure effects by working together to regulate circulating metabolites that fuel neurotransmitters in the brain. More specifically, their activity regulates gamma-aminobutyric acid (GABA), a neurotransmitter that acts like a brake to counterbalance the excitation of neurons by glutamate.
Microbes in the gut play a symbiotic role in human metabolism, which Bloom’s Reyes described as “a biological engine that has evolved with humans over thousands of years.” The specific bacteria identified by Hsiao’s team play a key role in maintaining “this very fine balance between GABA and glutamate.”
In a statement from the company, Hsiao said trillions of microbes in the gut are important for normal biology, including brain health. This discovery has the potential to impact many conditions that are associated with alterations in GABA, and could have applications for treatment beyond epilepsy in Alzheimer’s disease, Parkinson’s disease, autism, anxiety, and schizophrenia, she said.
After securing a license for the technology from UCLA, the startup has set out to develop proprietary products that represent a new class of neuroprotective medicines. (While bacteria are not considered patentable, Colasin said the company has licensed composition of matter patents.)
In the United States, some 3.5 million people are estimated to have epilepsy, according to the Centers for Disease Control and Prevention, and Colasin said as many as a third of them don’t respond to current anti-seizure drugs. Causes vary, and epileptic seizures are episodes that can range from brief and nearly undetectable moments to long periods of shaking that can be intense enough to break bones.
Unlike most biotechs, Colasin said Bloom Science has developed a rapid timeline for delivering its products to market over the next three years.
Based on the bacterial strains identified by Hsiao’s team, the company plans to develop a product that would be classified as a medical food, which would take a less stringent path for regulatory approval and lead to a designation that it is generally regarded as safe (GRAS). Colasin said Bloom also plans to pursue conventional regulatory approval as a Live Biotherapeutic Product for its proprietary strains of bacteria, leveraging the orphan drug pathway with the FDA.