Full Press Release Details
Summit Therapeutics Provides Update on Ri-CoDIFy Trials
Cambridge, Massachusetts - 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.
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.
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
About C. difficile Infection
Clostridioides 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
Contact Summit Investor Relations
Head of Investor Relations & Corporate
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.