Seres Therapeutics Announces Initiation of Phase 1b Trial of SER-301 for the Treatment of Ulcerative Colitis
November 06 2020 - 7:00AM
Business Wire
– SER-301 is designed to target the
physiological triggers of inflammation believed to be central to
the underlying pathology of ulcerative colitis –
– Program represents Seres’ second active
clinical program targeting ulcerative colitis, in addition to its
ongoing SER-287 Phase 2b study –
Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced that it
has dosed the first patient in its Phase 1b trial evaluating
SER-301 for the treatment of active mild-to-moderate ulcerative
colitis (UC). SER-301 is an oral, rationally-designed microbiome
therapeutic designed to dampen the aberrant gastrointestinal
inflammation central to ulcerative colitis and induce clinical
remission in patients suffering from active UC.
SER-301 is designed to modify the gastrointestinal microbiome
and microbe-associated metabolites to modulate multiple pathways
associated with ulcerative colitis. SER-301 is a consortium of
bacteria designed using Seres’ reverse translational discovery
platform that incorporates analysis of microbiome biomarkers from
human clinical data and preclinical assessments using human
cell-based assays and in vitro and in vivo disease models. SER-301
is designed to reduce induction of pro-inflammatory activity,
improve epithelial barrier integrity and TNF-α driven inflammation
in intestinal epithelial cells, and modulate UC-relevant
anti-inflammatory, innate and adaptive immune pathways. The design
of SER-301 incorporated learnings obtained through the Company’s
prior SER-287 Phase 1b clinical study conducted in patients with
ulcerative colitis. SER-287 Phase 1b study results demonstrated
favorable pharmacodynamic changes, signals of clinical activity,
and a favorable safety profile.
SER-301 was developed with innovative and novel manufacturing
methods that do not require human donor material. It includes
strains delivered in spore form and strains fermented in non-spore
(vegetative) form. The product candidate is delivered using
enterically-protected technology designed to release in the colon.
GMP manufacturing technologies developed through the SER-301
program broaden the breadth of biology that can be incorporated
into Seres’ microbiome therapeutics.
“Ulcerative colitis is a serious disease impacting approximately
700,000 individuals in the U.S. alone, and effective patient
management can be challenging. Currently approved treatments are
unable to induce disease remission in the large majority of
patients, and many existing drugs are associated with a suboptimal
safety profile,” said Matthew Henn, Ph.D., Executive Vice President
and Chief Scientific Officer of Seres. “We believe that microbiome
therapeutic approaches have the opportunity to address this
condition in an entirely novel way which targets the underlying
drivers of disease by modulating multiple disease-relevant pathways
simultaneously, and with a favorable safety profile. We are pleased
to have applied the deep scientific and clinical learnings obtained
from our SER-287 and other clinical programs combined with our
advanced microbiology and functional modeling capabilities to bring
SER-301 into this Phase 1b study.”
The SER-301 Phase 1b study is being conducted in Australia and
New Zealand in subjects with mild-to-moderate UC and is designed to
include approximately 65 patients distributed across two cohorts. A
first open-label cohort of 15 subjects will evaluate safety and
pharmacokinetics (PK), as measured by bacterial engraftment. In the
second cohort, 50 subjects will be randomized to receive either
SER-301 or placebo, with a 3:2 randomization, respectively. The
study utilizes an independent blinded central reader for the
endoscopic component. The objectives for this cohort are to
evaluate safety and PK, clinical remission, and other measures of
drug pharmacology and efficacy as secondary endpoints.
Seres is entitled to receive a $10 million milestone payment
associated with the clinical trial initiation from Nestlé Health
Science, the Company’s ex-North American collaborative partner for
this program.
About SER-301
SER-301 is an investigational, oral, rationally-designed,
fermented microbiome therapeutic for the treatment of
mild-to-moderate ulcerative colitis (UC). SER-301 is a consortium
of multiple bacterial strains manufactured by fermenting each
strain individually and then combining to form drug product. The
composition includes strains formulated in spore form and strains
fermented in non-spore, vegetative form. The product candidate is
delivered using enterically-protected technology designed to
release in the colon. SER-301 is designed to modify the microbiome
and microbe-associated metabolites in the gastrointestinal tract to
modulate pathways linked to gastrointestinal inflammation and to
improve epithelial barrier integrity in patients with ulcerative
colitis.
About Seres Therapeutics
Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome
therapeutics platform company developing a novel class of
multifunctional bacterial consortia that are designed to
functionally interact with host cells and tissues to treat disease.
Seres’ SER-109 program achieved the first-ever positive pivotal
clinical results for a targeted microbiome drug candidate and has
obtained Breakthrough Therapy and Orphan Drug designations from the
FDA. The SER-109 program is being advanced for the treatment of
recurrent C. difficile infection and has potential to become a
first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287
program has obtained Fast Track and Orphan Drug designations from
the FDA and is being evaluated in a Phase 2b study in patients with
active mild-to-moderate ulcerative colitis. Seres is evaluating
SER-401 in a Phase 1b study in patients with metastatic melanoma,
SER-301 in a Phase 1b study in patients with ulcerative colitis and
SER-155 to prevent mortality due to gastrointestinal infections,
bacteremia and graft versus host disease. 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 the timing and results of our
clinical studies, the ability of SER-301 to modulate the microbiome
of UC patients, the safety profile of our product candidates, the
receipt of milestone payments, the promise and success of
microbiome therapeutics, and other statements that are not
historical facts.
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 have incurred significant losses, are not currently
profitable and may never become profitable; our need for additional
funding; our limited operating history; our unproven approach to
therapeutic intervention; the lengthy, expensive, and uncertain
process of clinical drug development; our reliance on third parties
to manufacture, develop, and commercialize our product candidates,
if approved; the ability to develop and commercialize our product
candidates, if approved; the potential impact of the COVID-19
pandemic; our ability to retain key personnel and to manage our
growth; and that our management and principal stockholders have the
ability to control or significantly influence our business. These
and other important factors discussed under the caption “Risk
Factors” in our Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission, or SEC, on [July 28, 2020] and
our other reports filed with the SEC could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management’s estimates 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201106005080/en/
PR Contact Lisa Raffensperger
lisa@tenbridgecommunications.com
IR Contact Carlo Tanzi, Ph.D.
ctanzi@serestherapeutics.com
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