Startups, BioPharma

Start-up plans to target epilepsy using gut microbiota

Bloom Science plans to have its proprietary gut bacteria in the clinic for hard-to-treat patients in the next 12-18 months.

A company that will use gut microbiota to manage epilepsy has launched and plans to have a clinical trial up and running next year.

San Diego-based Bloom Science announced Thursday its launch and licensing of preclinical research showing the role of gut bacteria in the anti-seizure effects of the ketogenic diet. The low-carbohydrate, high-fat diet was developed in the 1920s and has been shown to manage seizures in rare forms of epilepsy.

However, compliance with the diet – which is used as a last-resort treatment – is a significant challenge for patients. As such, Bloom is developing a combination of microbes and medical food that is designed to mimic the diet’s neuroprotective properties, CEO Anthony Colasin said in a phone interview. The company plans to target the one-third of patients who fail to respond to existing epilepsy drugs, as well as the half of respondents who experience side effects that adversely affect their quality of life, according to the Thursday press release.

The plan is to file an Investigational New Drug (IND) application with the Food and Drug Administration for approval to begin a Phase I study within the next 12-18 months, Colasin said. The study will involve an orally administered, proprietary strain of the gut bacteria, and he said the safest assumption is that it would be in the form of a capsule. The company is also developing a medical food product that uses GRAS – generally regarded as safe – designation to establish safety and enable the company to transition directly into a proof-of-concept trial in patients.

Bloom said in its Thursday press release that it had closed a round of seed funding from industry insiders that will fund its research and development activities up through filing with the FDA to start its study. However, Colasin declined to disclose how much the company raised. Nevertheless, while also not disclosing how much Bloom would need to raise in a subsequent Series A round, he said it would not be a large one on the order of $40-50 million.

Microbiome drugs are expected to see significant growth in the coming years. According to a report by BCC Research in 2016, the global market for drugs and diagnostics based on the microbiome could reach $9.9 billion by 2024. The market is expected to cover a wide range of diseases, including cancers, diabetes, autoimmune diseases and others.

Photo: spawns, Getty Images

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