(This article has been corrected to indicate that Bloom Science is also developing a treatment under the traditional therapeutic route, in addition to a medical food).

A new epilepsy therapy that may help those who have the most severe forms of the disease is being developed by a San Diego biotech company. It expects to begin clinical testing next year.

The proposed treatment from Bloom Science uses two species of gut bacteria that thrive on special low-carb, high-fat “ketogenic” diets, along with ingredients that support their growth.

The treatment will be first developed not as a drug, but rather as a medical food, composed of ingredients generally recognized to be safe.


By following this regulatory pathway, Bloom Science can get to human testing far faster than by developing a drug, said CEO Tony Colasin. The company is also developing a traditional therapeutic, expected to reach the market later.

Medical foods are eaten under a doctor’s supervision to help manage a disease. They must be shown to address nutritional needs for the disease, as supported by scientific evidence.

The treatment could provide a new approach to control epilepsy, Colasin said. In the most intractable cases, patients may experience hundreds of seizures a day. And even those whose seizures are controlled may struggle with the side effects of the drugs they take.

The bacteria were identifed in a new study from UCLA that examined ketogenic diets in mice with epilepsy. The study was published Thursday in the journal Cell. It can be found at: j.mp/epilepsymicrobiome.


Patients and relatives can get more information at https://bloomscience.co/#patients.

Dr. James Grisolia, a neurologist who practices at Scripps Mercy Hospital, said the proposed therapy represents a new way of thinking about epilepsy by managing human-associated bacteria, the so-called microbiome.

This approach is being studied in other diseases, said Grisolia, who is also senior vice president of the Epilepsy Foundation of San Diego County. Bloom Science’s timetable for beginning a clinical trial seems reasonable, he said.

About 3.4 million Americans have epilepsy, more than 1 percent of the population, according to the Centers for Disease Control. Symptoms range over a spectrum from mild tics and “absence” seizures in which attention is lost momentarily to full-blown convulsions that affect the entire body.


“Anybody who has a seizure disorder is always at risk that an illness or other things can bring on seizures and (that) makes many people feel very insecure,” Grisolia said.

An estimated 30 percent to 40 percent of those with epilepsy can’t control their seizures. That number hasn’t budged in recent decades, despite new drugs reaching the market, Grisolia said.

In cases of what is called Sudden Unexpected Death in Epilepsy, or SUDEP, patients die for no apparent reason. It’s the leading cause of death among those with uncontrolled seizures, according to the Epilepsy Foundation.

Even when drug therapy is effective, it can produce unwanted side effects, such as dizziness, sedation and problems in concentrating, said Colasin, the Bloom Science CEO.


“The dizziness and sedation at a minimum have an impact on people’s ability to maintain a job, the ability to keep their (driver’s) license,” Colasin said. “We really see this as a place where we can intervene.”

Ketogenic diets have helped some patients whose seizures can’t be controlled any other way. They’re well tested and have been used for more than a century. They also don’t produce the unwanted mental side effects.

But these diets are very hard to adhere to, requiring precisely measured portions, so they’re usually a last resort. And just how these diets work has been unclear.

The UCLA study, conducted in mice, provides an explanation: The two bacterial species make chemicals that indirectly regulate brain activity. Bloom Science has licensed the technology from the University of California.


The study found that a ketogenic diet fed to the epileptic mice who lacked either of these bacterial species failed to inhibit seizures. But mice on the diet who were supplied with both bacterial species were protected.

Grisolia cautioned that studies in mice don’t necessarily apply to people. But the finding that the seizure-inhibiting effect of ketogenic diets depends on the presence of the bacteria is significant.

“It’s a whole new area that’s opening up as being potentially very promising,” Grisolia said. “This study is exciting, but it’s really the first step in a lot of work that would have to be done to really deliver results to people.”


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