Finch Therapeutics Provides an Update on its Phase 3 Trial of CP101 in Recurrent C. difficile Infection
March 01 2022 - 4:30PM
Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics” or
“Company”) (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 that it has paused enrollment in PRISM4, its Phase 3
clinical trial of CP101 in recurrent C. difficile infection (CDI)
following receipt of a clinical hold letter from the U.S. Food and
Drug Administration (FDA) on February 24, 2022, requesting
additional information about Finch’s SARS-CoV-2 donor screening
protocols.
At the outset of the COVID-19 pandemic in March 2020, the FDA
issued a public safety alert regarding the potential risk of
transmission of SARS-CoV-2 virus through the use of donor-derived
investigational microbiome therapies and the need for additional
safety precautions. At that time, the FDA placed Finch’s
investigational new drug application (IND) for CP101 and the IND of
its then-contract manufacturer, OpenBiome, on partial clinical
hold, requiring the implementation of SARS-CoV-2 testing protocols
for any microbiota material donated on or after December 1, 2019.
Notwithstanding the partial clinical hold notices, Finch was able
to continue dosing patients in its then-ongoing PRISM-EXT Phase 2
open-label trial of CP101 in recurrent CDI as all of the CP101 lots
used for PRISM-EXT were manufactured from material donated prior to
December 1, 2019.
In January 2021, Finch’s then-contract manufacturer, OpenBiome,
was released from clinical hold after implementing a direct testing
method for SARS-CoV-2 provided by a third-party vendor. In March
2021, Finch acquired certain manufacturing assets from OpenBiome,
and in November 2021, began dosing participants in PRISM4 with
CP101 lots that had been screened for SARS-CoV-2 using the same
test method and vendor used by OpenBiome.
Following communications with FDA in January 2022, on February
24, 2022, the FDA sent a letter stating that it needs additional
information about Finch’s SARS-CoV-2 screening protocols and that a
clinical hold remains in effect until the FDA’s requests have been
satisfactorily addressed. Finch has informed the FDA that
participants were dosed in PRISM4 while the clinical hold was in
effect and Finch is conducting a review of the matter.
In their letter the FDA requested, among other things,
additional detail on how samples are shipped to the vendor
performing the SARS-CoV-2 testing and how inconclusive test results
will be handled. The letter did not reference any adverse clinical
outcome experienced in any of Finch’s clinical trials. Finch
expects to expeditiously provide the requested information and
intends to work closely with the FDA to resolve the clinical hold
as soon as possible. Finch is evaluating what impact, if any,
the clinical hold may have on the timing of the expected readout of
topline data from the PRISM4 trial.
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.
Human-First Discovery® is a registered trademark of Finch
Therapeutics Group, Inc.
Cautionary Note Regarding 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 resolve the clinical hold including the likelihood that
the clinical hold will be lifted and timing of any such resolution;
Finch’s communication plans with the FDA related to the clinical
hold and the timing for receiving written correspondence from the
FDA; and Finch’s plans and expectations for discussions with the
FDA and the outcomes from the discussions. 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:
the risk that the written questions that Finch received from the
FDA may require Finch to collect additional data or information
beyond what it currently expects; the risk that Finch may not be
able to address the FDA’s concerns regarding SARS-CoV-2 testing
protocols quickly or at all; uncertainties relating to regulatory
applications and related filing and approval timelines, including
the risk that FDA may not remove the clinical hold; 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;
unexpected regulatory actions or delays, including requests for
additional safety and/or efficacy data or analysis of data, or
government regulation generally; the ability of Finch to comply
with regulatory requirements or experience unanticipated problems
with any of its product candidates; ongoing regulatory obligations
and continued regulatory review may result in significant
additional expense to Finch and Finch may 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 to support 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 November 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:
Stephen JasperGilmartin Group(858)
525-2047stephen@gilmartinir.com
Media Contact:
Jenna UrbanBerry & Company Public Relations(212)
253-8881jurban@berrypr.com
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