First-in-class antibiotic to treat serious infections caused by pathogens identified as a ‘critical priority’ by the World Health Organization (WHO) and as an ‘urgent threat’ by the US Centers for Disease Control and Prevention (CDC)
(BOSTON: May 18, 2021) – CARB-X is awarding Summit Therapeutics, (NASDAQ: SMMT) headquartered in Cambridge, MA, USA, with its Discuva subsidiary located in Cambridgeshire, UK, up to US$4.1 million in non-dilutive funding to develop a first-in-class antibiotic to treat multidrug-resistant infections, specifically carbapenem-resistant Enterobacteriaceae (CRE) infections including those caused by serious human pathogens such as Escherichia coli and Klebsiella pneumoniae. Under the award, Summit could receive additional funding of up to $3.7 million from CARB-X if project milestones are achieved, subject to available funds. The award will help the company progress the SMT-738 antibiotic project through preclinical and Phase 1a clinical development.
“The world urgently needs innovative therapeutics to address life-threatening pathogens that are constantly developing new ways of resisting the effects of antibiotics that are designed to kill them,” said Erin Duffy, R&D Chief of CARB-X, a non-profit global partnership led by Boston University and dedicated to supporting the development of innovative antibiotics, vaccines, diagnostics and other life-saving products to address antibiotic-resistant bacterial infections. “Summit’s SMT-738 represents a novel class that has a new mechanism of inhibition of bacterial cell membrane biosynthesis. These degrees of novelty combine to offer a potential advantage where antibiotic resistance is concerned.”
“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, as yet with 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.”
CRE are a family of bacteria that have been dubbed “Nightmare Bacteria” by health officials because they cause deadly infections that are difficult or impossible to treat, and spread rapidly. They can cause bloodstream infections, urinary tract infections, and hospital-acquired pneumonias. Some strains of multidrug-resistant Enterobacteriaceae are resistant to all existing antibiotics. CRE bacteria are more likely to emerge in healthcare settings, and infect patients using devices such as catheters or recovering from surgery. In the US, the CDC reports that CRE infections kill an estimated 1,100 patients every year.
Summit’s SMT-738 is the first of a novel class of antibiotics with a new mechanism of action that acts via the LolCDE complex, an essential lipid transport system in Gram-negative bacteria. Combining a novel antibiotic class (SMT-738) with a clinically unexploited target (LolCDE) is thought to mitigate the risk of pre-existing resistance, potentially allowing for the effective treatment of Enterobacteriaceae-related infections that currently have very limited treatment options due to resistance or toxicity of available treatments.
SMT-738 was discovered using Summit’s proprietary technology, the Discuva Platform. The company expects 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.”
Supporting global antibacterial innovation to address drug resistance
The CARB-X portfolio is the world’s largest and most diverse antibacterial R&D portfolio with 58 active projects focused exclusively on drug-resistant bacteria, including 18 focused on developing new classes of antibiotics. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics, vaccines, rapid diagnostics and other life-saving products. The goal is to support projects through the early phases of development so that they will attract additional private or public support for further clinical development and regulatory approval for use in patients.
Since its launch in 2016, CARB-X has announced 88 awards worth more than $330.9 million, with the potential of additional funds if project milestones are met. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons. The award for SMT-738 is Summit’s second CARB-X award to support the development of an innovative project.
CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High. The WHO estimates that 700,000 people die each year from antibiotic-resistant infections, including 35,000 in the US and 33,000 in Europe.
CARB-X funding for this project is provided by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from the Wellcome Trust and Germany’s Federal Ministry of Education and Research (BMBF). The contents of this release are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Administration for Strategic Preparedness and Response, or other CARB-X funders.
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Summit Therapeutics Inc.
Vice President, Investor Relations & Corporate Strategy
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global 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 Administration for Strategic 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). CARB-X is investing up to $480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. 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 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. 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.
About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK).
Education and research are the foundations for our future. The promotion of education, science and research by the German Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at firstname.lastname@example.org. www.bu.edu.