Seres’s investigational candidates unaffected by FDA alert

Seres Therapeutics (NASDAQ:MCRB) says its investigational therapeutic candidates — highly purified consortia of spore-based commensal bacteria — are fundamentally distinct from fecal microbiota transplantation and aren’t affected by a recent FDA alert.

On June 13, 2019, the FDA issued an alert regarding bloodstream infections with multi-drug resistant organisms transmitted through FMT; two immunocompromised adults who received FMT had developed invasive infections caused by extended-spectrum beta-lactamase-producing E. coli and one individual died.

Unapproved FMT is  widely used under an FDA Enforcement Discretion policy for the treatment of recurrent C. difficile infection not responsive to standard therapies; that policy doesn’t require safety monitoring and oversight that are standard requirements for investigational therapies under an IND.

The new FDA safety alert indicated that additional protections are needed for any investigational use of FMT including appropriate donor screening questions, testing of donor stool for MDROs and informing patients of the potential risk of infection and serious adverse reactions.

Seres remains supportive of continued patient access to FMT, particularly for those patients who may lack access to clinical trials. However, Seres believes that FMT use should be performed under an IND using pre-specified and mandatory safety reporting requirements appropriate for unapproved investigational therapies.

https://seekingalpha.com/news/3472301-seress-investigational-candidates-unaffected-fda-alert