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
positive topline results from PRISM-EXT, an open-label extension of
the company’s PRISM3 Phase 2 placebo-controlled trial evaluating
CP101 for the prevention of recurrent C. difficile infection (CDI).
PRISM-EXT was a 24-week trial that evaluated the
safety and efficacy of CP101 for the prevention of recurrent CDI in
132 participants who either rolled over from PRISM3 after
experiencing a CDI recurrence (n=50) or directly enrolled after
experiencing a CDI recurrence without previously participating in
PRISM3 (n=82). In the PRISM-EXT trial, there were no
treatment-related serious adverse events reported and CP101
exhibited an overall safety profile consistent with the profile
observed in PRISM3. The primary efficacy endpoint was sustained
clinical cure (defined as absence of CDI recurrence) through eight
weeks post-treatment. Overall, 80.3% of participants who received a
single oral administration of CP101 following standard-of-care
(SOC) antibiotics in PRISM-EXT achieved sustained clinical cure
through week 8. At week 24, 78.8% of participants had sustained
clinical cure. The PRISM-EXT results are consistent with and build
on the previously reported PRISM3 results, which showed that CP101
provided a statistically significant improvement in the prevention
of recurrent CDI compared to placebo through 8 weeks and 24 weeks
post-treatment.
“The robust PRISM-EXT topline results add to the
growing body of evidence supporting the potential for CP101 to meet
the need for a convenient, orally administered therapeutic that can
prevent recurrent C. difficile infection,” said Jessica R.
Allegretti, MD, MPH, Principal Investigator in the PRISM-EXT and
PRISM3 trials at Brigham and Women’s Hospital in Boston. “I am
excited to participate in the ongoing evaluation of this novel
therapeutic candidate.”
PRISM-EXT Trial Design and Additional
Results
The PRISM-EXT trial was a multi-center, open-label
extension of the PRISM3 Phase 2 randomized, placebo-controlled
trial evaluating CP101 for the prevention of recurrent CDI. The
primary endpoints were safety and sustained clinical cure (absence
of CDI recurrence) through 8 weeks post-treatment. Participants
were followed for a total of 24 weeks for safety and sustained
clinical cure. PRISM-EXT enrolled adults of any age with one or
more CDI recurrences. Following successful completion of SOC
antibiotics, participants were treated with a single oral
administration of CP101 without bowel preparation. There were two
cohorts of participants; one cohort directly enrolled in the trial
following a recent CDI recurrence without having previously
participated in PRISM3 (n=82) and one cohort enrolled after
experiencing a CDI recurrence following administration of placebo
or a single dose of CP101 in PRISM3 (n=50).
Among the 102 participants who were treated with
CP101 in PRISM3, 20 were enrolled in PRISM-EXT and treated with a
second dose of CP101. Of the participants who received either a
single dose of CP101 in PRISM3 (n=82) or a second dose by enrolling
in PRISM-EXT (n=20), a post-hoc analysis shows that a total of 90
participants achieved sustained clinical cure through 8 weeks after
their final dose, resulting in a cumulative efficacy of 88.2%
(n=102).
In PRISM-EXT, treatment-related adverse events were
of mild to moderate severity, and primarily gastrointestinal in
nature, with no treatment-related serious adverse events reported
through week 24. Finch plans to present additional data from
PRISM-EXT at a future medical conference.
“These data provide hope to patients suffering from
recurrent C. difficile infection,” said Sahil Khanna, MBBS,
Co-Investigator in the PRISM-EXT and PRISM3 trials at the Mayo
Clinic in Rochester. “A proportion of patients who contract C.
difficile become trapped in repeating cycles of infection.
Standard-of-care antibiotics effectively treat the active
infection, but most antibiotics disrupt the intestinal microbiome
and its ability to fight off C. difficile, putting patients at high
risk for recurrence. CP101 is a promising option for restoring the
microbiome and breaking the cycle of CDI recurrence.”
PRISM4 Phase 3 Trial Update
Finch also announced today the start of enrollment
in PRISM4, a Phase 3, randomized, double-blind, placebo-controlled,
global trial that will evaluate the efficacy and safety of a single
oral administration of CP101 for the prevention of recurrent
CDI.
“We look forward to continuing to advance the
clinical development of CP101, with our PRISM4 Phase 3 trial now
enrolling and topline data expected in 2023,” said Mark Smith, PhD,
Chief Executive Officer of Finch Therapeutics. “We believe the
encouraging CP101 data from PRISM3 and PRISM-EXT, the largest
reported dataset to our knowledge for any orally administered
investigational microbiome therapeutic, underscore the potential
for microbiome therapeutics to transform care for recurrent CDI as
well as other conditions linked to disruption of the intestinal
microbiome.”
Finch expects to enroll approximately 300
participants in PRISM4, with the trial designed to serve as a
second pivotal trial to support the development of CP101 for the
prevention of recurrent CDI.
About CP101
CP101 is an investigational microbiome therapeutic
designed to deliver a complete 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, which are believed to contribute to
colonization resistance. CP101 is manufactured under a rigorous,
standardized process. CP101 is in late-stage clinical development
for the prevention of recurrent CDI.
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 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
therapeutics that restore the microbiome following SOC antibiotics
and 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.
With the capabilities to develop both complete and targeted
microbiome therapeutics, Finch is advancing a rich pipeline of
candidates designed to address a wide range of unmet medical needs.
Finch’s lead candidate, CP101, is in late-stage clinical
development for the prevention of recurrent C. difficile infection
(CDI), and has received Breakthrough Therapy and Fast Track
designations from the U.S. Food and Drug Administration. In June
2020, Finch announced that CP101 met its primary efficacy endpoint
in PRISM3, the first of two pivotal trials to support the
development of CP101 for the prevention of recurrent CDI. PRISM4, a
Phase 3 trial, is designed to serve as the second pivotal trial of
CP101 for recurrent CDI. Finch is also developing CP101 for the
treatment of chronic hepatitis B virus, and FIN-211 for the
treatment of the gastrointestinal and behavioral symptoms of autism
spectrum disorder. Finch has a partnership with Takeda focused on
the development of targeted microbiome therapeutics for
inflammatory bowel disease.
Human-First Discovery® is a registered trademark of
Finch Therapeutics Group, Inc.
Forward-Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended. Words such as
“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: Finch’s ability to advance its platform of
microbiome therapeutics; the therapeutic and commercial potential
of CP101; and the structure and timing of PRISM4, Finch’s Phase 3
clinical trial of CP101 in recurrent CDI, including specifically
the period in which topline data from PRISM4 will be available and
the number of participants that will be enrolled in the trial.
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: 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;
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; anticipated
regulatory approvals may be delayed or refused; 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 in anticipation of commencement of
multiple global clinical trials; 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 Quarterly Report on Form
10-Q filed with the SEC on August 10, 2021, 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:
Laurence WattsGilmartin Group(619)
916-7620laurence@gilmartinir.com
or
Stephen JasperGilmartin Group(858)
525-2047stephen@gilmartinir.com
Media Contact:Jenna UrbanBerry
& Company Public Relations(212) 253-8881jurban@berrypr.com
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