Novel broad-spectrum antibiotic compound prioritized for development in fight against AMR

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

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New Delhi: The Global Antibiotic Research & Development Partnership (GARDP) and Bugworks Research Inc. (Bugworks) has 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-inhuman (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.