Based on a thorough review of the design and enrollment
status of two ongoing blinded Phase III Ri-CoDIFy trials, Summit
Therapeutics Inc. (NASDAQ: SMMT) today announced that it will
combine its two blinded pivotal Phase III clinical trials
evaluating ridinilazole versus vancomycin into a single study.
Ridinilazole, a novel first-in-class drug, is
currently under investigation for use as first-line therapy for the
treatment of initial and recurrent Clostridioides difficile
infection. The trial’s primary endpoint seeks to prove
ridinilazole’s superiority in sustained clinical response as
compared to vancomycin. Ridinilazole is not currently approved for
use by any regulatory authority.
Current enrollment in the two Ri-CoDIFy Phase
III trials is 753 patients, split approximately evenly between each
of the two trials. This enrollment level offers a unique
opportunity to combine the studies, as the two ongoing trials have
enrolled just over 50% of their targeted goal, are still blinded,
and allow for a prospectively planned analysis.
“In spite of a worldwide healthcare, COVID-19
pandemic-driven crisis and an unprecedented challenge in enrolling
patients in clinical trials in the current setting, we are proud of
the enrollment achieved within these two clinical trials,” said Dr.
Maky Zanganeh, Summit’s Chief Operating Officer and a Director of
the company. “In the best interest of all Summit and Ri-CoDIFy
study stakeholders, including patients, physicians, hospitals, and
other facilities providing care for patients with infectious
diseases, the correct and appropriate action to take at this time
is to prospectively plan to combine the two Ri-CoDIFy trials and to
analyze the data. A positive result from the combined study could
form the basis of a presentation of the trial results to the
regulatory authorities and inform further decisions on next
steps.”
The ridinilazole clinical program commenced with
the Phase I trial beginning in 2012, a 100-patient Phase II
clinical trial began in 2014, and the current Ri-CoDIFy Phase III
clinical trials enrolled the first patient in February 2019.
The company recently released breakthrough Phase
II clinical study data, including the relative sparing of
ridinilazole on the gut microbiome as compared to vancomycin,
ridinilazole’s minimal impact on the gut resistome, and its novel
mechanism of action1.
“On behalf of Team Summit, we would like to
express our thanks to each of our investigators, healthcare
providers, patients, and the associated facilities, as well as
BARDA for their collaboration and support of our clinical trials,”
stated Robert W. Duggan, Summit’s Chairman and Chief Executive
Officer. “We look forward to concluding these studies and assessing
the trial data in the coming months.”
This effort is funded in whole or 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.
About Summit Therapeutics
The overriding objective of Summit Therapeutics
is to create value for patients, hospital caregivers, and
community-based healthcare providers, as well as healthcare payers
around the world. We seek to create value by developing drugs with
high therapeutic efficacy - curing the cause of the patient's
condition with minimal or zero disease recurrence or antimicrobial
resistance, for the longest extent possible - and minimizing the
trauma caused to the patient and healthcare ecosystem by minimizing
serious side effects, disease recurrence, and inaccessibility to
our treatments as a result of financial or other barriers. Summit
Therapeutics, empowered by its Discuva Platform, the Company’s
innovative antibiotic discovery engine, and supported by BARDA and
CARB-X funding, intends to be the leader in patient-friendly and
paradigm-shifting treatments for infectious diseases and other
significant unmet medical needs while being an ally to physicians.
Our new mechanism pipeline product candidates are designed with the
goal to become the patient-friendly, new-era standard of care, by
working in harmony with the human microbiome to treat prospective
patients suffering from infectious diseases, initially focusing on
Clostridioides difficile infection (CDI). Currently, Summit’s lead
product candidate, ridinilazole, is a novel, first-in-class drug
engaged in a global Phase III trial program versus vancomycin, for
use as first-line therapy for the treatment of initial and
recurrent Clostridioides difficile infection, and to show
superiority in sustained clinical response. Commercialization of
ridinilazole is subject to regulatory approvals. SMT-738, the
second candidate within Summit’s portfolio, is currently in the
IND-enabling phase for the treatment of multidrug resistant
infections, specifically those caused by carbapenem-resistant
Enterobacteriaceae (CRE).
For more information, please visit
https://www.summittxinc.com and follow us on Twitter @summitplc.
For more information on the Company’s Discuva Platform, please
visit https://www.summittxinc.com/our-science/discuva-platform.
About C.
difficile InfectionClostridioides
difficile, or C. difficile, infection (CDI) is a bacterial
infection of the colon that produces toxins causing inflammation of
the colon, severe watery diarrhea, painful abdominal cramping,
nausea, fever, and dehydration. CDI can also result in more serious
disease complications, including bowel perforation, sepsis, and
death. CDI is a contagious infectious disease that represents a
serious healthcare issue in hospitals, long-term care facilities,
and the wider community. Summit estimates that there are
approximately 500,000 cases of CDI each year across the United
States with acute care costs exceeding $5.4 billion in the US based
on a meta-analysis published in the Journal of Global Health, June
2019.
Contact Summit Investor Relations
Dave GancarzHead of Investor 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 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
uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical
trials and the results of such trials, 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, 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.
1 E. Duperchy et al. ECCMID 2021, abstract P02515; E. Duperchy
et al. ECCMID 2021, abstract P03486; T. Avis et al. ECCMID 2021,
abstract P03404.
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