Summit Therapeutics to Present Ri-CoDIFy Trial Results for
Microbiome-Sparing Ridinilazole at IDWeek 2022
Menlo Park, California, October 13, 2022 – Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) and its product candidate, ridinilazole, will have an oral podium presentation and a poster presentation at IDWeek 2022. IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), the 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).
The oral presentation, entitled “Ri-CoDIFy – A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ridinilazole Compared with Vancomycin for the Treatment of Clostridioides difficile Infection” will provide details of the results of the Ri-CoDIFy trial for our investigational, first-in-class antibiotic, ridinilazole, for the treatment of Clostridioides difficile infection (“C. diff. infection,” or “CDI”).
In the Ri-CoDIFy study, ridinilazole resulted in a meaningful reduction in the rate of recurrence of C. diff. infection (8.1% vs 17.3%) and achieved a numerically higher sustained clinical response1 rate (73.0% vs 70.7%) than vancomycin.
In The Journal of Infectious Diseases (Jul 2021), Drs. Maria Y. Giovanni, Johanna S. Schneider, Thomas Calder, and Anthony S. Fauci noted:
Now is the time to refocus microbiota research beyond association studies and advance research on the mechanisms that underly the causal links between the human microbiota and infectious and immune-mediated diseases. … Commensal [co-existing] organisms influence susceptibility to infection by protecting against invasion, maintaining their own colonization, and resisting subsequent colonization by pathogens. … The importance of a healthy gut microbiota is made evident by the effects of antibiotics, which can wreak havoc by altering the composition and diversity of the gut microbiota and disrupt the ability to prevent colonization by pathogens. Antibiotics can increase susceptibility to bacterial enteric infections, including infections with Clostridium difficile…. In addition, reduced bacterial diversity of the human gut microbiota is associated with COVID-19 infection.2
Consistent with the premise from Dr. Giovanni, et. al., which included Dr. Fauci as the senior author, higher microbiome diversity was associated with a lower CDI recurrence rate in the Ri-CoDIFy study. This will be the first in-depth presentation of the large and comprehensive assessment of the microbiome-sparing effects of ridinilazole as compared to the effects of vancomycin when treating patients with C. diff. infection. We are pleased to inform that the results of our clinical study validated the assertions of Drs. Giovanni, Schneider, Calder, and Fauci.
The poster, entitled “A US-Based National Surveillance Study for the Susceptibility and Epidemiology of Clostridioides difficile Associated Diarrheal Isolates with Special Reference to Ridinilazole: 2020-2021” will be available throughout IDWeek 2022, which takes place between October 19-23, 2022.
Ridinilazole is not currently approved for use by any regulatory authority.
The presentation and poster will be available within the “Scientific Literature & Publications” section of our website: https://www.summittxinc.com/publications/.
1 Sustained clinical response (“SCR”) is defined as a clinical response by the patient and no recurrence of CDI through 30 days after the end of the treatment regimen.
2 Giovanni, Schneider, Calder, and Fauci. Refocusing Human Microbiota Research in Infectious and Immune-Mediated Diseases: Advancing to the Next Stage. The Journal of Infectious Diseases, Vol. 224, Issue 1: 5-8, Jul 2021.
Summit Therapeutics’ Mission Statement
To 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 Therapeutics
Summit 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 Gancarz
Head of Stakeholder Relations & Corporate Strategy
david.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.
