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South San Francisco-based Second Genome. Both of those companies have secured some modest support from Johnson & Johnson, and both are still in preclinical development. Both also are different than Seres. Second Genome is developing traditional small-molecule chemical compounds as therapies, and while Vedanta is also using a live cocktail of microbes, it is aiming that product candidate against inflammatory bowel disease.
Peter DiLaura, the CEO of Second Genome, said fecal transplants have been effective, which has stirred excitement about the potential of what live bacterial therapeutics might do. One drawback, however, will be the manufacturing challenges, he says.
“It’s certainly an interesting approach—there are questions about the sort of mechanism of action they’re using,” DiLaura says.
The lead drug candidate to come from Seres’s approach to microbiome drug development is called SER-109. It’s designed to treat patients who have C. difficile infections that are resistant to vancomycin, a powerful antibiotic given in hospitals. This bug, which often lurks in hospitals and strikes the elderly, is estimated to kill as many as 14,000 people a year in the U.S., Seres says, although data has traditionally been hard to gather on the true extent of the bug’s reach. By going after C. difficile, Seres essentially aspires to compete with Lexington, MA-based Cubist Pharmaceuticals (NASDAQ: CBST), which recently acquired a potent antibiotic against “C. diff” from Optimer Pharmaceuticals.
Although Seres says it has begun its first clinical trial, there is no public listing of the trial on clinicaltrials.gov. Berry said he wasn’t ready to discuss any details of the study, such as how many patients it seeks to enroll, whether it will be randomized and controlled, or which people are involved at which clinical sites.
All of the technology at Seres has been internally developed, meaning none of it comes from any license from an external source, Berry says. Besides the lead product candidate against C. diff infections, Seres aims to make microbiome-based treatments against infectious, metabolic, and inflammatory diseases.