Cambridge, MA,
May 18, 2021 -
Summit Therapeutics Inc. (NASDAQ: SMMT) announced today that it has
selected a new preclinical candidate, SMT026738 (“SMT-738”), for
development in the fight against multidrug resistant infections,
specifically carbapenem-resistant Enterobacteriaceae (CRE)
infections. Simultaneously, Summit has received an award from
CARB-X to progress this candidate through preclinical development
and Phase 1a clinical trials. The award commits initial funding of
up to $4.1 million, with the possibility of up to another $3.7
million based on the achievement of future milestones.
SMT-738 is the first of a novel class of
precision antibiotics with a new mechanism of action that acts via
the bacterial target, LolCDE. SMT-738 has the potential to treat
multidrug resistant infections caused by a large family of
pathogenic Gram-negative bacteria, the Enterobacteriaceae, that
include serious human pathogens such as Escherichia coli and
Klebsiella pneumoniae. Combining a novel antibiotic class (SMT-738)
with a clinically unexploited target (LolCDE) mitigates the risk of
pre-existing resistance, potentially allowing for the effective
treatment of Enterobacteriaceae-caused infections that currently
have very limited and failing treatment options due to resistance
to existing antibiotic classes.
“Our mission at Summit is to create patient- and
societal-friendly medicinal therapies that improve the quality and
duration of patients’ lives, while resolving serious unmet needs,”
said Robert W. Duggan, Executive Chairman and Chief Executive
Officer of Summit. “SMT-738 has the potential to save the lives of
patients with as yet untreatable infections through a novel drug
class with a low propensity for resistance development. We are
excited and optimistic to take on the real challenge of antibiotic
resistance and are grateful to CARB-X for partnering with us in
support of this important mission.”
SMT-738 was discovered using Summit’s
proprietary technology, our Discuva Platform, as a part of the
DDS-04 series, and we retain worldwide clinical development and
commercial rights to the compound. We expect to begin Phase 1
studies in 2023.
“With the growing threat of antibiotic
resistance, particularly with respect to CRE infections, SMT-738 is
clearly differentiated from all agents, including the
beta-lactamase inhibitors, that are currently used to treat such
infections,” adds David Powell, Ph.D., Summit’s Chief Scientific
Officer. “By leveraging the transposon libraries of bacteria within
our Discuva Platform, we have identified the target to be the
clinically unexploited LolCDE complex, an essential lipid transport
system in Gram-negative bacteria. SMT-738 has potent in vitro
activity against clinical CRE isolates including difficult to treat
metallo-beta-lactamase carrying strains encoding the New Delhi
Metallo-beta-lactamase (NDM). Having encountered no existing
resistance in clinical isolates to the novel chemistry of SMT-738,
the ability of our drug molecule to reset the clock against growing
resistance is critical in our collective fight against these
pathogens causing an urgent public health threat.”
Carbapenem-resistant Enterobacteriaceae are
considered an Urgent Threat by the US Centers for Disease Control
and Prevention (CDC) and a Critical Priority by the World Health
Organization (WHO) for which new treatments are urgently
needed.
About Enterobacteriaceae
Enterobacteriaceae are a family of bacteria
responsible for serious infections across a number of conditions
including bloodstream infections, urinary tract infections, and
hospital-acquired pneumonias. Multidrug resistant
Enterobacteriaceae are resistant to treatment by most or
occasionally all existing antibiotics. The most difficult to treat
among them are the carbapenem-resistant Enterobacteriaceae, which
are classified as an Urgent Threat by the US Centers for Disease
Control and Prevention (CDC).
About SMT-738
SMT-738 is a novel, first-in-class, new
mechanism, precision antibiotic targeting Enterobacteriaceae.
SMT-738 is a small molecule antibiotic that acts via LolCDE, an
essential bacterial complex responsible for the transport of
lipoproteins from the inner to outer membrane in Gram-negative
bacteria. Because this complex has not been a previous target of
existing antimicrobials, bacterial resistance does not yet exist to
this targeted approach, potentially allowing for the treatment of
highly-resistant Enterobacteriaceae-caused infections. Some of
these infections, particularly in a subset of CRE-caused
infections, have limited or failing treatment options through
currently available antibiotics. SMT-738 has
successfully completed preliminary repeat dose toxicology
studies.
About CARB-X
CARB-X (Combating Antibiotic-Resistant Bacteria
Biopharmaceutical Accelerator) is a global non-profit partnership
dedicated to supporting early development antibacterial R&D to
address the rising threat of drug-resistant bacteria. CARB-X is led
by Boston University and funding is provided by the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response
(ASPR) in the US Department of Health and Human Services; the
Wellcome Trust, a global charity based in the UK working to improve
health globally; Germany’s Federal Ministry of Education and
Research (BMBF); the UK Department of Health and Social Care’s
Global Antimicrobial Resistance Innovation Fund (GAMRIF); the Bill
& Melinda Gates Foundation, and with in-kind support from
National Institute of Allergy and Infectious Diseases (NIAID), part
of the US National Institutes of Health (NIH) within the US
Department of Health and Human Services. CARB-X is investing up to
US$480 million from 2016-2022 to support innovative antibiotics and
other therapeutics, vaccines and rapid diagnostics. CARB-X focuses
exclusively on high priority drug-resistant bacteria, especially
Gram-negatives. CARB-X is headquartered at Boston University School
of Law. For more information, visit https://carb-x.org/. Follow us
on Twitter @CARB_X.
About Summit Therapeutics
Summit Therapeutics, empowered by its Discuva
Platform, the Company’s innovative antibiotic discovery engine,
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 disease,
initially focusing on Clostridioides difficile infections (CDI).
The overriding objective of Summit Therapeutics is to create value
for patients, hospital caregivers, and community-based disease
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.
Currently, Summit’s lead product candidate, ridinilazole, is
engaged in two pivotal global Phase 3 trials, Ri-CoDIFy 1 & 2,
each enrolling approximately 680 patients vs. the standard of care
(vancomycin) for the treatment and reduction of recurrence of C.
difficile infections in addition to an adolescent trial, Ri-CoDIFy
3. Commercialization of ridinilazole for the treatment and the
reduction of recurrence of CDI is subject to regulatory approvals.
SMT-738, the second candidate within Summit’s portfolio of
products, 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 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.
Contact Summit Investor
Relations:
Dave GancarzVice President, Investor Relations
& Corporate Strategydavid.gancarz@summitplc.com
General Inquiries: investors@summitplc.com
Contact
CARB-X:
Jennifer RobinsonCommunications
Leadcarbxpr@bu.edu
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. 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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