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 clinical data supporting CP101 for the prevention
of recurrent C. difficile infection (CDI) at the American College
of Gastroenterology (ACG) Annual Scientific Meeting being held
October 22-27, 2021 in a hybrid format. Results from PRISM3, a
Phase 2, randomized, placebo-controlled, multi-center clinical
trial evaluating the investigational orally administered candidate
CP101 for the prevention of recurrent CDI, including new 24-week
safety and efficacy data, will be shared in two posters and an oral
presentation at the meeting.
“We are excited to share these additional data supporting CP101,
the first orally administered microbiome candidate to demonstrate
durable efficacy and a favorable safety profile in a large
randomized, placebo-controlled trial that included all stages of
recurrent CDI and all guideline recommended methods of CDI
diagnosis at trial entry. These are important features of the
PRISM3 trial that we believe position CP101 to serve a broad
patient population,” said Zain Kassam, MD, MPH, Chief Medical
Officer at Finch Therapeutics. “We believe these robust PRISM3 data
illustrate the potential for CP101 to serve as a convenient,
first-line option for clinicians and patients fighting the
devastating effects of recurrent CDI.”
Summary of PRISM3 posters presented at the ACG
meeting:
Poster Title: “Week 24 Efficacy and Safety Data from PRISM3: A
Randomized, Placebo-Controlled Trial Evaluating CP101, an
Investigational Orally Administered Microbiome Therapeutic for
Prevention of Recurrent C. difficile Infection” (P0130)
- CP101 demonstrated efficacy through
week 24, with 73.5% of participants in the CP101 arm (n=102)
experiencing a sustained clinical cure (defined as absence of CDI
recurrence) through week 24 versus 59.4% in the placebo arm (n=96)
(p=0.0347).
- CP101 exhibited a favorable safety
profile through week 24, with similar rates of adverse events and
drug-related treatment emergent adverse events in both the CP101
and placebo arm. No drug-related serious adverse events were
reported in the CP101 arm through week 24.
- As previously reported, CP101 met
its primary efficacy endpoint in PRISM3, with 74.5% of participants
who received a single oral administration of CP101 following
standard-of-care (SOC) antibiotics achieving a sustained clinical
cure through week 8, versus 61.5% of participants who received
placebo following SOC antibiotics (p=0.0488), representing a 33.8%
relative risk reduction for CDI recurrence.
Poster Title: “CP101 Engraftment Drives Efficacy: Results from a
Randomized, Placebo-Controlled Trial Evaluating CP101, an
Investigational Orally Administered Microbiome Therapeutic for
Prevention of Recurrent C. difficile Infection” (P0129)
- Treatment with CP101 in PRISM3
resulted in significant engraftment at week 1, with engraftment
defined as the presence of CP101-specific microbes that colonized
the gastrointestinal tract of participants.
- CP101 engraftment was associated
with sustained clinical cure in PRISM3. Among PRISM3 participants
with successful engraftment at week 1 following administration of
CP101, 96.0% achieved a sustained clinical cure at week 8, while
unsuccessful engraftment resulted in a 54.2% sustained clinical
cure rate, similar to participants who were administered placebo
following CDI antibiotics (p<0.001).
- Engraftment of CP101 microbes may
have been impacted by the persistence of residual broad-spectrum
vancomycin, despite participants completing a minimum two-day
washout period to ensure antibiotic clearance from the colon. Data
suggest that a two-day washout period may be insufficient to clear
residual vancomycin. Future trials, including PRISM4, a Phase 3,
placebo-controlled trial of CP101 for recurrent CDI, will deploy
strategies to optimize engraftment by further minimizing the effect
of residual broad-spectrum antibiotics.
In addition to the two poster presentations, Jessica R.
Allegretti, MD, MPH, Associate Director, Crohn's and Colitis
Center, Brigham and Women’s Hospital, Assistant Professor, Harvard
Medical School, will give an oral presentation on Tuesday, October
26, 2021 at 9:30 am PT entitled “CP101, an Investigational Orally
Administered Microbiome Therapeutic, Increases Intestinal
Microbiome Diversity and Prevents Recurrent C. difficile Infection:
Results From a Randomized, Placebo-Controlled Trial” (oral abstract
#25). The abstract was awarded ACG’s prestigious Outstanding
Research Award.
The presented data are available to registered attendees through
the ACG Annual Scientific Meeting website and copies of the posters
will be provided on the Finch website after the meeting.
About CP101
CP101 is an investigational microbiome therapeutic that delivers
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
contributes 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,
including Finch’s ability to position CP101 to serve a broad
patient population; and the therapeutic value and commercial
potential of CP101. 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
Relations212-253-8881jurban@berrypr.com
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