Drug Development

Seres doubles down on a microbiome do-over as the FDA clears a make-or-break study

Seres CEO Roger Pomerantz

Seres CEO Roger Pomerantz says he’s back on track.

Eight months after the biotech industry’s leading microbiome program derailed in a disastrous Phase II, Seres’ chief says he and his team persuaded regulators at the FDA to sign off on a new study that could provide pivotal data on his top program. And now he’ll double down on a trial that will once again roll the dice on a cutting-edge effort to develop a gut-level therapy that can right a challenging health wrong.

Back last July, Seres was hammered hard after the company said its Phase II study of SER-109 failed to demonstrate efficacy in reducing the recurrence of Clostridium difficile infection. The therapy barely separated from a placebo, crushing the biotech’s share price.

The key difference between this new “pivotal worthy” study and Seres’ failed trial is a dose that is 10 times as high as what it started out with. And the CEO — a longtime Merck vet — is convinced that the biotech has it right.

This time around Seres will recruit 320 patients “at multiple sites in the US and Canada,” says the CEO, “to make it as pivotally robust as possible…We’ve gotten pretty good at this.” And the trial will get underway later this year, with a plan to line up CMC manufacturing and more to be ready for an OK and commercialization.

Bold words and big plans.

Pomerantz has explained all this to me once before, which I wrote up. But the comeback case has had virtually no effect on his stock price, which has continued to reside in biotech’s dog house. Now he’ll get a chance to redeem himself and the company, either ending up on the threshold of a landmark OK or miring the company so deep in the muck that it may never get out.

Nestlé Health Science, which paid $120 million upfront to partner on CDI at the beginning of 2016, also has a lot riding on this. Their pact included some $2 billion in milestones for four programs, along with a commitment to help pay for late-stage development.

When you double down on success, the consequences of a potential failure aren’t easy to ignore. And the outcome will have significant implications for all the startups in the microbiome field — whether they like it or not.


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