Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”)
(Nasdaq: FNCH), a clinical-stage microbiome therapeutics company
leveraging its Human-First Discovery® platform to develop a novel
class of orally administered biological drugs, today announced the
presentation of biomarker data from PRISM-EXT, a Phase 2 open-label
trial of CP101 in recurrent C. difficile infection (CDI), at the
American College of Gastroenterology (ACG) 2022 Annual Scientific
Meeting, being held October 21-26, 2022 in Charlotte, NC. Finch
also announced today that the company has proceeded with patient
dosing in PRISM4, a Phase 3 trial of CP101 for the prevention of
recurrent CDI.
“This is an exciting time for Finch and the overall microbiome
field, with hope and new potential therapeutic options on the
horizon for patients fighting recurrent CDI,” said Howard Franklin,
MD, MBA, Chief Medical Officer of Finch Therapeutics. “At ACG’s
annual meeting, we are pleased to be presenting biomarker data from
our PRISM-EXT trial showing that higher engraftment of CP101
microbes and an increase in intestinal microbiome diversity were
both associated with prevention of recurrent CDI. These results
further our understanding of the pharmacokinetics and
pharmacodynamics of CP101 and support our efforts to optimize
engraftment of CP101 microbes.”
Dr. Franklin continued, “We are also very pleased to be back in
the clinic with CP101 and are deeply grateful to our PRISM4 study
sites and study participants for their dedication to supporting the
development of CP101. We will continue to work with urgency to
advance CP101, an investigational microbiome therapeutic that we
believe holds the promise of fulfilling the need for a convenient,
one-time oral therapy that can break the cycle of CDI
recurrence.”
The PRISM-EXT poster details are as follows:
Poster Title: Evaluation of Engraftment and Diversity Following
Open Label Administration of CP101, an Investigational Oral
Microbiome Therapeutic for the Prevention of Recurrent C. Difficile
Infection, in the PRISM-EXT Trial (E0096)Presenting Author: Jessica
R. Allegretti, MD, MPH, Brigham and Women's Hospital, Boston, MA
and Harvard Medical School, Boston MAPresentation Date and Time:
Tuesday, October 25, 2022 at 3:00 pm ET
- Following open-label administration
of CP101 after standard-of-care (SOC) CDI antibiotics, there was a
significant increase in microbiome diversity from baseline through
week 8 and week 24 in PRISM-EXT participants.
- Higher engraftment of
CP101-associated taxa and improvement in diversity were both
associated with prevention of CDI recurrence through week 8.
- As previously reported, 80.3% and
78.8% of participants who received CP101 following SOC antibiotics
in PRISM-EXT were without CDI recurrence through week 8 and week
24, respectively (n=132). The CP101 safety results from PRISM-EXT
were consistent with previously reported results, with no
treatment-related serious adverse events or deaths. The most
frequent treatment-related adverse events were gastrointestinal
symptoms of mild-moderate severity.
PRISM-EXT was a Phase 2, multi-center, open-label trial of CP101
for the prevention of recurrent CDI in adults with one or more CDI
recurrences. The primary endpoints were safety and the proportion
of participants without CDI recurrence through week 8. Participants
were followed through week 24 for safety and CDI recurrence.
Exploratory microbiome endpoints were measured at baseline
following SOC antibiotics, week 8 and week 24 using 16S rRNA gene
amplicon sequencing. A copy of the PRISM-EXT poster presented at
ACG will be available on the ‘Publications’ page of the Finch
website after the meeting.
About CP101
CP101 is an investigational microbiome therapeutic designed to
deliver a diverse microbial community in a one-time oral
administration, without the need for bowel preparation. CP101 is
designed to enable prevention of recurrent C. difficile infection
(CDI) by restoring a diverse microbial community and key
physiological pathways that are believed to contribute to
colonization resistance.
About the PRISM4 Phase 3 Trial
PRISM4 is a randomized, double-blind, placebo-controlled,
multi-center Phase 3 trial evaluating the efficacy and safety of a
one-time oral administration of CP101 for the prevention of
recurrent C. difficile infection (CDI). After completing
standard-of-care CDI antibiotics for their most recent CDI
recurrence, eligible participants will be randomized in a 2:1 ratio
to receive either CP101 or placebo. Participants will be evaluated
for CDI recurrence and safety through week 8, the primary endpoint,
as well as through week 24. Participants who qualify may enroll in
the optional open label arm and receive CP101 if they experience a
CDI recurrence through week 8 of the trial. To learn more about the
trial, visit clinicaltrials.gov (Identifier: NCT05153499) or the
study website at https://prism4trial.com/.
About Recurrent C. difficile
Infection
Clostridioides difficile infection (CDI), one of the most common
healthcare-associated infections, is a debilitating and sometimes
life-threatening disease that is characterized by severe diarrhea
and abdominal pain. Recurrent CDI is common following the use of
standard-of-care (SOC) antibiotics to treat active CDI. SOC
antibiotics can lead to significant disruption of the intestinal
microbiome, which impairs colonization resistance, or the ability
of a healthy microbiome to inhibit the colonization and expansion
of pathogens, which can put patients at risk for recurrent CDI.
There is a significant unmet need for FDA-approved, orally
administered therapeutics that restore the microbiome following SOC
antibiotics and that may enable early intervention to prevent
recurrent CDI.
About Finch Therapeutics
Finch Therapeutics is a clinical-stage microbiome therapeutics
company leveraging its Human-First Discovery® platform to develop a
novel class of orally administered biological drugs. Finch’s lead
candidate, CP101, is in late-stage clinical development for the
prevention of recurrent C. difficile infection and has received
Breakthrough Therapy and Fast Track designations from the U.S. Food
and Drug Administration. Finch is exploring strategic options to
potentially advance the development of its pre-clinical candidates
FIN-524 for ulcerative colitis and FIN-525 for Crohn's disease and
its pre-clinical program in autism spectrum disorder. Finch
routinely posts information that may be important to its investors
on its website at www.finchtherapeutics.com. Finch encourages
investors to consult the “Investors & News” section of its
website regularly.
Human-First Discovery® is a registered trademark of Finch
Therapeutics Group, Inc.
Forward-Looking Statements
This press release includes “forward-looking statements.” Words
such as “will,” "anticipates," "believes," "expects," "intends,"
“plans,” “potential,” "projects,” “would” and "future" or similar
expressions are intended to identify forward-looking statements.
These forward-looking statements include, but are not limited to,
statements regarding: the therapeutic potential of options on the
horizon for treatment of recurrent CDI, including Finch’s product
candidate, CP101; Finch’s efforts to optimize engraftment of CP101
microbes and its plans to work with urgency to advance development
of CP101; performance of Finch’s PRISM4 trial; and Finch’s ability
to develop a novel class of orally administered biological drugs.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. These risks and
uncertainties include, among others, those related to: Finch’s
limited operating history and historical losses; Finch’s ability to
raise additional funding to complete the development and any
commercialization of its product candidates; Finch’s dependence on
the success of its lead product candidate, CP101; the possibility
that Finch may be delayed in initiating, enrolling or completing
any clinical trials, including PRISM4; results of clinical trials
may not be indicative of final or future results from later stage
or larger clinical trials (or in broader patient populations once
the product is approved for use by regulatory agencies) or may not
be favorable or may not support further development; Finch’s
product candidates may not generate the benefits to patients that
are anticipated; results of clinical trials may not be sufficient
to satisfy regulatory authorities to approve Finch’s product
candidates in their targeted or other indications (or such
authorities may request additional trials or additional
information); Finch’s ability to comply with regulatory
requirements; ongoing regulatory obligations and continued
regulatory review may result in significant additional expense to
Finch and Finch could be subject to penalties for failure to
comply; competition from third parties that are developing products
for similar uses; Finch’s ability to maintain patent and other
intellectual property protection and the possibility that Finch’s
intellectual property rights may be infringed, invalid or
unenforceable or will be threatened by third parties; Finch’s
ability to qualify and scale its manufacturing capabilities;
Finch’s lack of experience in selling, marketing and distributing
its product candidates; Finch’s dependence on third parties in
connection with manufacturing, clinical trials and preclinical
studies; and risks relating to the impact and duration of the
COVID-19 pandemic on Finch’s business. These and other risks are
described more fully in Finch’s filings with the Securities and
Exchange Commission (“SEC”), including the section titled “Risk
Factors” in Finch’s Annual Report on Form 10-K for the year ended
December 31, 2021 filed with the SEC on March 31, 2022, as
supplemented by Finch’s Quarterly Reports on Form 10-Q filed with
the SEC on May 16, 2022 and August 11, 2022, as well as discussions
of potential risks, uncertainties, and other important factors in
Finch’s other filings with the SEC. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Except to the extent required by law, Finch
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Investor Contact:Stephen JasperGilmartin
Group(858) 525-2047stephen@gilmartinir.com
Media Contact:Jenna UrbanBerry & Company
Public Relations(212) 253-8881jurban@berrypr.com
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