Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” "we," or the
“Company”) today provided an update with respect to the clinical
development of ridinilazole, its lead Phase III product candidate
for the treatment of patients with Clostridioides difficile
infection (“C. diff. infection” or “CDI”).
This week, Summit and the US Food & Drug
Administration (the “FDA”) held a Type C meeting during which
Summit discussed certain data from the Ri-CoDIFy Phase III clinical
trial with the agency. The FDA and Summit discussed a possible
pathway in which to advance ridinilazole forward with the goal of
achieving marketing authorization. This pathway would involve
reasonable efforts that would likely involve at least one
additional clinical trial. We plan to explore this possibility.
We also plan to share the results from our
Ri-CoDIFy Phase III clinical trial through an oral abstract
presentation at IDWeek 2022, a major medical conference scheduled
to be held in Washington, DC in October. IDWeek is the joint annual
meeting of the Infectious Diseases Society of America (IDSA),
Society for Healthcare Epidemiology of America (SHEA), the HIV
Medicine Association (HIVMA), the Pediatric Infectious Diseases
Society (PIDS), and the Society of Infectious Diseases Pharmacists
(SIDP).
About the Ri-CoDIFy StudyThe
Ri-CoDIFy Phase III trial, combining Ri-CoDIFy 1 (NCT: 03595553)
and Ri-CoDIFy 2 (NCT: 03595566), is a multi-center, international,
double-blinded active-controlled randomized clinical trial
comparing ridinilazole, an investigative drug, against vancomycin
that randomized 759 patients with C. diff. infection. Patients were
randomized 1:1 to receive either ridinilazole or vancomycin.
Ridinilazole was administered twice daily for ten days; vancomycin
was administered four times daily for ten days. Patients receiving
ridinilazole were provided with two placebo pills per day to
maintain consistency of administration between the two arms. For
inclusion within the study, each patient was required to have a
positive C. difficile free toxin test and require antimicrobial
treatment for CDI.
The Ri-CoDIFy Phase III study was funded in part
with federal funds from the Biomedical Advanced Research and
Development Authority (BARDA), part of the Office of the Assistant
Secretary for Preparedness and Response at the U.S. Department of
Health and Human Services, under contract number
HHSO100201700014C.
Summit Therapeutics’ Mission
StatementTo build a viable, long-lasting health care
organization that assumes full responsibility for designing,
developing, trial execution and enrollment, regulatory submission
and approval, and successful commercialization of patient,
physician, caregiver, and societal-friendly medicinal therapy
intended to: improve quality of life, increase potential
duration of life, and resolve serious medical healthcare needs. To
identify and control promising product candidates based on
exceptional scientific development and administrational expertise,
develop our products in a rapid, cost-efficient manner, and to
engage commercialization and/or development partners when
appropriate.
We accomplish this by building a team of world
class professional scientists and business administrators that
apply their experience and knowledge to this mission. Team Summit
exists to pose, strategize, and execute a path forward in medicinal
therapeutic health care that places Summit in a well-deserved, top
market share, leadership position. Team Summit assumes full
responsibility for stimulating continuous expansion of knowledge,
ability, capability, and well-being for all involved stakeholders
and highly-valued shareholders.
About Summit TherapeuticsSummit
was founded in 2003 and our shares are listed on the Nasdaq Global
Market (symbol ‘SMMT’). We are headquartered in Menlo Park,
California, and we have additional offices in Oxford, UK, and
Cambridge, UK.
For more information, please visit
https://www.summittxinc.com and follow us on Twitter
@summitplc.
Contact Summit Investor Relations:
Dave GancarzHead of Stakeholder Relations &
Corporate Strategydavid.gancarz@summitplc.com
General Inquiries:
investors@summitplc.com
Summit Forward-looking Statements
Any statements in this press release about the
Company’s future expectations, plans and prospects, including but
not limited to, statements about the clinical and preclinical
development of the Company’s product candidates, the therapeutic
potential of the Company’s product candidates, the potential
commercialization of the Company’s product candidates, the timing
of initiation, completion and availability of data from clinical
trials, the potential submission of applications for marketing
approvals, the impact of the COVID-19 pandemic on the Company’s
operations and clinical trials, potential acquisitions and other
statements containing the words "anticipate," "believe,"
"continue," "could," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project," "should," "target," "would," and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including the results of our evaluation of the underlying
data in connection with the topline results of our Phase III
Ri-CoDIFy study evaluating ridinilazole, the outcome of discussions
with regulatory authorities, including the Food and Drug
Administration, the uncertainties inherent in the initiation of
future clinical trials, availability and timing of data from
ongoing and future clinical trials, the results of such trials, and
their success, and global public health crises, including the
coronavirus COVID-19 outbreak, that may affect timing and status of
our clinical trials and operations, whether preliminary results
from a clinical trial will be predictive of the final results of
that trial or whether results of early clinical trials or
preclinical studies will be indicative of the results of later
clinical trials, whether business development opportunities to
expand the Company’s pipeline of drug candidates, including without
limitation, through potential acquisitions of, and/or
collaborations with, other entities occur, expectations for
regulatory approvals, laws and regulations affecting government
contracts and funding awards, availability of funding sufficient
for the Company’s foreseeable and unforeseeable operating expenses
and capital expenditure requirements and other factors discussed in
the "Risk Factors" section of filings that the Company makes with
the Securities and Exchange Commission. Any change to our ongoing
trials could cause delays, affect our future expenses, and add
uncertainty to our commercialization efforts, as well as to affect
the likelihood of the successful completion of clinical development
of ridinilazole. Accordingly, readers should not place undue
reliance on forward-looking statements or information. In addition,
any forward-looking statements included in this press release
represent the Company’s views only as of the date of this release
and should not be relied upon as representing the Company’s views
as of any subsequent date. The Company specifically disclaims any
obligation to update any forward-looking statements included in
this press release.
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