Seres Therapeutics to Highlight VOWST™ Data at IDWeek
12 Octubre 2023 - 6:00AM
Business Wire
Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced multiple
abstracts to be presented at IDWeek 2023 in Boston, Massachusetts
(October 11-15, 2023), including two posters of post-hoc analyses
from the ECOSPOR III and ECOSPOR IV Phase 3 trials, which supported
the recent approval by the US Food and Drug Administration (FDA) of
VOWST as the first orally-administered microbiota-based therapeutic
for the prevention of recurrent C. difficile infection (rCDI) in
adults following antibacterial treatment for rCDI. VOWST is
commercialized in collaboration with Nestlé Health Science.
“The data we are presenting this year at IDWeek build upon our
earlier findings that the gastrointestinal microbiome is similarly
disrupted in patients with first or multiple rCDI. The introduction
of VOWST has provided a means to alleviate suffering and health
risks associated with recurrent instances of this serious disease,"
said Matthew Henn, Ph.D., Chief Scientific Officer at Seres.
Details for illustrative Seres-sponsored oral presentation and
posters are below:
- Poster Title: Analysis of Microbiome Diversity and
Secondary Bile Acid Synthesis Following SER-109 or Placebo in
Patients with First Recurrent or Multiply Recurrent Clostridioides
difficile Infection
- Poster/Abstract Number: 655
- Date/Time: Thursday, October 12 at 12:15 – 1:30
p.m. ET
- Poster Title: Rapid Change in Microbiome Profiles
Regardless of Diagnostic Method in a Post Hoc Comparative Analysis
of Phase 3 Trials of Fecal Microbiota Spores, Live-brpk (formerly
SER-109) for the Prevention of Recurrent Clostridioides difficile
Infection (rCDI)
- Poster/Abstract Number: 653
- Date/Time: Thursday, October 12 at 12:15 – 1:30
p.m. ET
INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST
INDICATION
VOWST is indicated to prevent the recurrence of Clostridioides
difficile infection (CDI) in individuals 18 years of age and older
following antibacterial treatment for recurrent CDI (rCDI).
Limitation of Use: VOWST is not indicated for treatment of
CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious agents: Because VOWST is
manufactured from human fecal matter, it may carry a risk of
transmitting infectious agents. Report any infection that is
suspected to have been transmitted by VOWST to Aimmune
Therapeutics, Inc. at 1-833-246-2566.
Potential presence of food allergens: VOWST may contain
food allergens. The potential to cause adverse reactions due to
food allergens is unknown.
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥5% of
participants) were abdominal distension (31.1%), fatigue (22.2%),
constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
To report SUSPECTED ADVERSE REACTIONS, contact Aimmune
Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at
1-800-FDA-1088, or visit www.fda.gov/MedWatch.
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
Please see Full Prescribing Information and Patient
Information
About Recurrent C. difficile Infection (rCDI)
Recurrent C. difficile infection is a gastrointestinal infection
caused by C. difficile bacteria. rCDI is linked to dysbiosis of the
gastrointestinal microbiome and is associated with increased
morbidity and mortality. CDI has been characterized as an Urgent
Health Threat by the Centers for Disease Control and Prevention
(CDC). rCDI results in a substantial burden on the healthcare
system1 with the average rCDI-related annual costs per patient at
approximately $43K.2
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage
company developing novel microbiome therapeutics for serious
diseases. Seres’ lead program, VOWST™, obtained U.S. FDA approval
in April 2023 as the first orally administered microbiota-based
therapeutic to prevent recurrence of C. difficile infection (CDI)
in adults following antibacterial treatment for recurrent CDI and
is being commercialized in collaboration with Nestlé Health
Science. Seres is evaluating SER-155 in a Phase 1b study in
patients receiving allogeneic hematopoietic stem cell
transplantation. The Company is also conducting research to inform
further development of microbiome therapeutics for ulcerative
colitis. 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 ability for microbiome
therapeutics to treat and prevent infections, and other statements
which are not historical fact.
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; the impact of the COVID-19
pandemic; our unproven approach to therapeutic intervention; our
reliance on third parties and collaborators to conduct our clinical
trials, manufacture our product candidates and develop and
commercialize our product candidates, if approved; the unknown
degree and competing factors of market acceptance for VOWST; the
competition we will face; our ability to protect our intellectual
property; and our ability to retain key personnel and to manage our
growth. 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 (SEC), on August 8,
2023, 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.
References
- U.S. Bureau of Labor Statistics. CPI Inflation Calculator. U.S.
Bureau of Labor Statistics. Published 2022.
https://www.bls.gov/data/inflation_calculator.htm. CPI inflation
adjusted to March 2023.
- Rodrigues R, Barber GE, Ananthakrishnan AN. A Comprehensive
Study of Costs Associated With Recurrent Clostridium difficile
Infection. Infect Control Hosp Epidemiol. 2016;38:196-202. DOI:
10.1017/ice.2016.246
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231012809202/en/
Seres IR and PR Contact: Kevin Mannix
kmannix@serestherapeutics.com
Seres Therapeutics (NASDAQ:MCRB)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Seres Therapeutics (NASDAQ:MCRB)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024