Geneva and Bangalore, 11 June 2024 – The Global Antibiotic Research & Development Partnership (GARDP) and Bugworks Research Inc. (Bugworks) today announced a collaboration agreement to co-develop an innovative compound (BWC0977) with broad-spectrum antibiotic activity against multidrug-resistant bacteria that cause life-threatening infections. Under the agreement, GARDP will provide up to US$20 million to Bugworks in technical and financial support for the pharmaceutical and clinical co-development of BWC0977. In return, Bugworks has granted GARDP manufacturing and commercialization rights for BWC0977 in 146 countries, almost all of which are low- or middle-income (LMICs).

BWC0977 has in vitro activity against a broad spectrum of pathogens that lead to serious hospital-acquired infections like pneumonia, bloodstream infections and complicated urinary tract infections. Among these pathogens are WHO critical priority pathogens, carbapenem-resistant Acinetobacter baumannii and Klebsiella pneumoniae, for which few treatment options exist. According to the GRAM study, these two pathogens alone account for over one-fifth of deaths associated with antimicrobial resistance (AMR) in 2019. The study also shows that, in many countries around the world, over 80% of A. baumannii clinical isolates were carbapenem-resistant.

“We are excited to work with Bugworks to make key investments at this critical stage in the development of compound BWC0977,” said Manica Balasegaram, Executive Director of GARDP. “Many compounds in the antibiotic pipeline lack innovative characteristics and fail to target priority pathogens. In contrast, BWC0977 stands out for its novelty and potential to address unmet public health needs.”

“Bugworks is delighted to partner with GARDP to advance compound BWC0977 through clinical development to treat a variety of drug-resistant bacterial infections,” said Anand Anandkumar, co-founder and CEO of Bugworks. “An overarching goal of this partnership is to enable access to this compound simultaneously in Western countries and in LMICs with high AMR burden. We are grateful to CARB-X for their continued support for BWC0977 from lead optimization to human clinical trials, thus enabling the asset to enter the GARDP collaborative orbit.”

The development of BWC0977 reflects the bolstering of the global health ecosystem to respond to the AMR crisis. Bugworks was set up in 2014 and incubated at the Centre for Cellular and Molecular Platforms (C-CAMP) in Bengaluru, India. Since 2017, CARB-X has provided critical support for the pre-clinical development and first-in-human (phase 1) clinical study of this compound, including US$12.47 million in funding. GARDP will now collaborate with Bugworks to further develop BWC0977 and, upon approval, enable global access.

“We are proud of our financial and non-financial support for the Bugworks programme, which began in lead optimization, delivered BWC0977 as a development candidate and ultimately commenced a first-in-human programme,” said Erin Duffy, R&D Chief at CARB-X. “Now that this compound has been primed for advanced development, we look forward to GARDP’s support in bringing this potential novel, broad-spectrum antibiotic to patients.”

GARDP’s technical and financial support of this project is tied to the successful completion of key R&D milestones that align with GARDP’s public health objectives. GARDP will initially bring expertise and financial support for critical aspects of BWC0977’s pharmaceutical development, including product formulation. Later investments will support clinical development and chemistry, manufacturing and controls activities to ensure that the final product is suitable for use in diverse countries and contexts, including low-resource settings.

About GARDP 

The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit organization that develops new antibiotic treatments for drug-resistant bacterial infections that pose the greatest threat to human health, and makes them accessible to the people who need them. It puts public health needs at the centre of antibiotic drug development to address the immediate crisis of antimicrobial resistance (AMR). Its work is funded by the governments of Canada, Germany, Japan, Monaco, the Netherlands, South Africa, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as Global Health EDCTP3, the RIGHT Foundation, Wellcome and other private foundations. GARDP was created by the World Health Organization and the Drugs for Neglected Diseases initiative (DNDi) in 2016 and legally registered as the GARDP Foundation in Geneva, Switzerland in 2018. http://www.gardp.org 

About Bugworks Research Inc. 

Bugworks Research Inc. (Bugworks) is a clinical-stage biopharmaceutical company that is developing novel multi-target therapeutic assets in the anti-infectives and oncology areas by integrating the latest innovations in computational biology, pharmacology, structural-biology, and medicinal chemistry. BWC0977 is currently in a Phase I clinical trial and is targeted to address unmet needs of serious hospital & community infections, and bacterial biothreats. Its lead asset for oncology is in the late pre-clinical stage, targets multiple cancers and is expected to be used either as standalone or in combination with immune checkpoint therapies. www.bugworksresearch.com

About CARB-X

CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. 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 on the WHO list. https://carb-x.org/ | (formerly Twitter) @CARB_X

CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number 75A50122C00028, and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.