Seres Therapeutics, Inc. Announces FDA Orphan Drug Designation for SER-109 for the Prevention of Recurrent Clostridium difficile Infection in Adults
CDI is one of the U.S. Centers for Disease Control’s top three most urgent antibiotic-resistant bacterial threats. It is the leading cause of hospital-acquired infection in the U.S., and is responsible for the deaths of approximately 29,000 Americans each year. Recurrent CDI affects between 85,000 and 110,000 people in the U.S. annually
"Receiving orphan drug designation from the
Antibiotics are currently the only
Results from a Phase 1b/2 study of SER-109 in recurrent CDI patients showed that 87 percent of patients achieved efficacy endpoint per protocol, and 97 percent of patients achieved a clinical cure, which was defined as the absence of CDI requiring antibiotic treatment during the eight-week period after SER-109 dosing.
Seres is currently conducting a multicenter, randomized, placebo-controlled Phase 2 clinical study to assess the efficacy and safety of SER-109 in preventing recurrent CDI. The primary outcome measure is the absence of CDI through eight weeks following administration of SER-109 compared to placebo. We expect the results from this study to be available in the middle of 2016.
The FDA Orphan Drug Designation program provides a special status to
drugs and biologics intended to treat, diagnose or prevent rare diseases
and conditions that affect fewer than 200,000 people in the U.S., or
that affect more than 200,000 people but are not expected to recover the
costs of developing and marketing the product in the U.S. The
designation provides Seres with certain benefits, including a seven-year
marketing exclusivity period for this indication upon approval of
SER-109, tax credits for clinical research expenses incurred in the
U.S., and an exemption from
In addition to Orphan Designation, in
About SER-109
SER-109 is the lead Ecobiotic® microbiome therapeutic in clinical testing for the treatment of recurrent Clostridium difficile infection (CDI). SER-109 was developed utilizing the Seres Microbiome Therapeutics™ platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to a healthier state. CDI is a rapidly growing problem associated with antibiotic use. Approximately 85,000 to 110,000 CDI patients in the U.S. have more than one recurrence each year.
About
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, without limitation, statements regarding the progress of the clinical development of SER-109, the treatment potential of SER-109, the ability of SER-109 to restore the microbiome, and the timing of the results from studies of SER-109.
These forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance or achievements
to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements,
including, but not limited to, the following: we are not currently
profitable and may never become profitable; our need for additional
funding, which may not be available; our limited operating history; the
unpredictable nature of our early stage development efforts for
marketable drugs; the unproven approach to therapeutic intervention of
our microbiome therapeutics; the lengthy and expensive process of
clinical drug development, which has an uncertain outcome; potential
delays in enrollment of patients which could affect the receipt of
necessary regulatory approvals; potential delays in regulatory approval,
which would impact the ability to commercialize our product candidates
and affect our ability to generate revenue; any fast track or
Breakthrough Therapy designation may not lead to faster development,
regulatory approval or marketing approval; our possible inability to
receive orphan drug designation should we choose to seek it; our
reliance on third parties to conduct our clinical trials and the
potential for those third parties to not perform satisfactorily; our
reliance on third parties to manufacture our product candidates, which
may delay, prevent or impair our development and commercialization
efforts; our lack of experience in manufacturing our product candidates;
the potential failure of our product candidates to be accepted on the
market by the medical community; our lack of experience selling,
marketing and distributing products and our lack of internal capability
to do so; failure to compete successfully against other drug companies;
potential competition from biosimilars; failure to obtain marketing
approval internationally; post-marketing restrictions or withdrawal from
the market; anti-kickback, fraud, abuse, and other healthcare laws and
regulations exposing us to potential criminal sanctions; recently
enacted or future legislation; compliance with environmental, health,
and safety laws and regulations; protection of our proprietary
technology; protection of the confidentiality of our trade secrets;
changes in
These and other important factors discussed under the caption “Risk
Factors” in our quarterly report on Form 10-Q filed with the
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