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/.
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 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
StatementsAny 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.
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.
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