FDA alert does not impact Seres’ microbiome investigational
therapeutic candidates
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 19, 2019--
Seres
Therapeutics, Inc. (Nasdaq: MCRB) (“Seres”) today provided a
statement on a safety alert from the U.S. Food and Drug Administration
(FDA) regarding bloodstream infections with multi-drug resistant
organisms (MDROs) transmitted through fecal microbiota transplantation
(FMT). On June 13th, 2019, the agency stated that two
immunocompromised adults who received FMT developed invasive infections
caused by extended-spectrum beta-lactamase (ESBL)-producing E. coli
and that one individual died. The donor stool used was not tested for
the pathogen linked to the infection.
Seres’ investigational therapeutic candidates, highly purified consortia
of spore based commensal bacteria, are fundamentally distinct from FMT
and are not impacted by the FDA alert. In contrast to unapproved FMT,
Seres’ therapeutic candidates are being evaluated in controlled clinical
studies conducted under an Investigational New Drug application (IND)
with rigorous safety monitoring and reporting procedures. The Company’s
therapeutic candidates are manufactured under GMP conditions and
quality-controlled using stringent standards to ensure product quality
and consistency.
Unapproved FMT is widely used under an FDA Enforcement Discretion policy
for the treatment of recurrent C. difficile infection (CDI) not
responsive to standard therapies. This policy does not require the
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. The agency encourages
healthcare providers to report suspected adverse events to the FDA.
Until a safe and effective FDA-approved microbiome drug is available for
the treatment of C. difficile, Seres remains supportive of
continued patient access to FMT, particularly for those patients who may
lack access to clinical trials. However, Seres believes that all FMT use
should be performed under an IND using pre-specified and mandatory
safety reporting requirements appropriate for unapproved investigational
therapies. In addition, Seres also supports increased FDA scrutiny
regarding unproven promotional claims related to FMT efficacy and safety.
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a leading microbiome
therapeutics platform company developing a novel class of biological
drugs that are designed to treat disease by restoring the function of a
dysbiotic microbiome, where the state of bacterial diversity and
function is imbalanced. Seres’ SER-287 program has obtained Fast Track
and Orphan Drug designation from the U.S. Food and Drug Administration
and is being evaluated in a Phase 2b study in patients with active
mild-to-moderate ulcerative colitis. Seres’ SER-109 program has obtained
Breakthrough Therapy and Orphan Drug designations from the FDA and is in
Phase 3 development for recurrent C. difficile infection. Seres
is also developing SER-401 in a Phase 1b study in patients with
metastatic melanoma. For more information, please visit www.serestherapeutics.com.
Forward-looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. All
statements contained in this press release that do not relate to matters
of historical fact should be considered forward-looking statements,
including statements relating to FDA approval of Seres’ therapeutic
candidates. Any forward-looking statements represent management’s
opinions as of the date of this press release. While we may elect to
update such forward-looking statements at some point in the future, we
disclaim any obligation to do so, even if subsequent events cause our
views to change. These forward-looking statements should not be relied
upon as representing our views as of any date subsequent to the date of
this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190619005176/en/
Source: Seres Therapeutics, Inc.
IR and PR Contact
Carlo Tanzi, Ph.D., Seres Therapeutics,
617-203-3467
Vice President, Investor Relations and Corporate
Communications
ctanzi@serestherapeutics.com
