GSK’s oral antibacterial drug candidate is now in clinical testing and aims to treat and prevent recurrent UTIs

(BOSTON: September 22, 2020) – CARB-X announced today it is awarding up to US$7.51 million to GlaxoSmithKline (NYSE: GSK), to develop a new drug to treat and prevent recurrent urinary tract infections (UTIs) caused by the Escherichia coli (E. coli) bacteria.

“Serious bacterial infections are a global health threat, due in part to the emergence of drug-resistant bacteria for which we do not have therapies,” said Erin Duffy, CARB-X R&D Chief.  “GSK’s project is in the early stages of development, and if successful, could potentially treat and prevent recurrent UTIs caused by E. coli and stop harmful bacteria from spreading in the body.”

UTIs are among the most frequent bacterial infections. UTIs occur when bacteria from the skin or periurethral area enter the urethra and infect the urinary tract and bladder. More women than men develop these infections, at a ratio of 8:1. An estimated 40-50 per cent of women will develop a UTI in their lifetime.

Most uncomplicated UTIs are caused by E. coli. Antibiotic resistance in E. coli is of particular concern because it is the most common Gram-negative pathogen in humans. Antibiotic resistance rates in E. coli are rapidly rising, especially with regard to fluoroquinolones and third- and fourth-generation cephalosporins. Many multidrug-resistant strains of the bacteria are found in the community, for example in the food supply.

Innovative approach to address the rise of drug resistance

GSK’s orally bioavailable small molecule drug, GSK3882347, targets an adhesive protein found on the surface of E. coli bacteria called FimH. Binding of GSK3882347 to FimH prevents E. coli from binding to the bladder wall, thereby preventing infection. With CARB-X support, the project aims to explore the safety, tolerability and pharmacokinetics of the FimH antagonist in a First Time in Human Phase 1 study which was initiated in September 2020 and is planned to be completed in 2021. The support also facilitates scale-up of the drug for future clinical and non-clinical studies.

“This CARB-X support will advance an innovative molecule that has the potential to change the way resistant bacterial infections are treated,” said John Lepore, SVP, Head of Research, GSK. “This Phase 1 study joins GSK’s other existing antibacterial programs – now numbering more than 20 active projects targeting the prevention and treatment of important pathogens — and represents our commitment to finding new and different ways to tackle antimicrobial resistance.”

Antibacterial drug development is a long and costly high-risk process. According to industry estimates, it can take more than 14 years and typically costs more than $1.5 billion to discover and develop a new medicine, and to do all the research necessary for a medicine to be approved by regulatory agencies for use in patients. At a time when most major pharmaceutical companies have moved away from antibiotic research, GSK has continued to invest in antibacterial R&D and potential new medicines.

Supporting innovation to address the global drug-resistance crisis

The World Health Organization (WHO) estimates that 700,000 people die each year from drug-resistant bacterial infections, including 35,000 in the US and 33,000 in Europe.

The CARB-X portfolio is the world’s largest and most diverse early development antibacterial R&D portfolio with 46 active projects focused exclusively on drug-resistant bacteria. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics and other life-saving products. The goal is to support projects through the early phases of development through Phase 1 so that they will attract additional private or public support for further clinical development and approval for use in patients. CARB-X funds only projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (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 on the WHO list.

Since its launch in 2016, CARB-X has announced 68 major awards to product developers in 10 countries, representing $250 million, with the potential of additional funding 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 stop for a variety of reasons.

This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The contents 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.

Contacts:

CARB-X:
Jennifer Robinson
+1.514.914.8974
carbxpr@bu.edu

GlaxoSmithKline:
Simon Moore
+44 (0) 20 8047 5502  (London)

About CARB-X
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 GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

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. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 55 BARDA-supported products have achieved FDA approval, licensure or clearance. 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).

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 jeremy22@bu.edu. www.bu.edu.