The Global Antibiotic Research & Development Partnership (GARDP) is joining forces with Bugworks Research Inc. (Bugworks), an innovative clinical-stage biopharmaceutical company with research and development facilities in Bangalore, India, to accelerate the development of a new broad-spectrum antibiotic compound aimed at treating serious infections caused by multidrug-resistant bacteria.
The compound being developed by Bugworks, BWC0977, is aimed at treating patients with serious bacterial infections in both critical care and community settings. BWC0977 has the potential to treat infections that are becoming progressively difficult to treat due to the increase of antimicrobial resistance (AMR) in pathogens, such as Acinetobacter baumannii and Klebsiella pneumoniae. These pathogens can cause hospital-associated infections, such as pneumonia, bloodstream infections, meningitis, and urinary tract infections.
“Since 2019, we have been following with interest the development of BWC0977 as a potential treatment for drug-resistant infections caused by the most harmful and deadly bacteria on the WHO priority pathogens list,” said Dr Manica Balasegaram, GARDP’s Executive Director. “We are delighted to be able to accelerate the development of this promising antibiotic compound, by supporting clinical and pharmaceutical development activities, with the hope of getting it to patients where it is most needed.”
This asset has been supported by CARB-X since 2017, through optimization and preclinical development and into first-in-human clinical studies.
GARDP and Bugworks have signed a term sheet to initiate this collaboration, with the goal of formalizing it through a collaboration agreement by end of the year.
According to the term sheet, GARDP would provide resources and funding for up to US$20 million to ensure a robust development programme for BWC0977. It would work with Bugworks to advance BWC0977 through Phase II and Phase III studies, and support its pharmaceutical development. The funds would be disbursed based on the achievement of key milestones aligned with development steps and GARDP’s public health objectives.
“We are thrilled to strengthen our ongoing partnership with GARDP to accelerate the clinical development of BWC0977 and deliver a truly differentiated broad-spectrum drug that can tackle the toughest drug-resistant superbugs,” said Dr Anand Anandkumar, co-founder and CEO of Bugworks. “By leveraging GARDP’s unique global AMR network and clinical development expertise, we aim to achieve our goal of ‘Go to Globe’, ensuring equitable access to this drug to patients across the planet. The strong support enabled by CARB-X has primed Bugworks’ collaboration with GARDP.”
As part of the intended collaboration, GARDP would work with Bugworks on a development and commercialization project for the compound, whereby Bugworks would launch it in the European Union, US, Japan, China, directly or through sublicensees, and GARDP would obtain manufacturing rights and commercialization rights in a total of 148 countries, including nearly all low and middle-income countries.
One of the priorities for Bugworks and GARDP is to work closely to ensure rapid access and appropriate use of this compound, once approved, in India and South Africa, and in other high-burden countries where BWC0977 could have a significant public health impact.
The phase I trial of BWC0977 is being conducted in Australia, with funding and technical support from CARB-X. “Bugworks was the second company to apply for funding from CARB-X, back in 2016, and we have accelerated BWC0977 all the way from lead optimization, through preclinical development and into first-in-human clinical studies,” said Kevin Outterson, Executive Director of CARB-X and Austin B. Fletcher Professor at Boston University School of Law. “We are grateful to GARDP for collaborating with Bugworks on the advanced development of BWC0977. This is aligned with the global stewardship and access commitments which we ask every CARB-X recipient to make when they join our portfolio.”
In 2020, GARDP and Bugworks signed a Memorandum of Understanding (MOU) to explore antibiotic development to tackle serious bacterial infections in high-burden countries. In 2022, GARDP provided support for a cardiac safety study embedded in the ongoing first-in-human study that will provide an early assessment of potential cardiovascular risk of BWC0977.
Serious bacterial infections occurring in hospitals and other healthcare settings often lead to sepsis and death without prompt and effective treatment. Currently, the most difficult-to-treat infections are caused by Gram-negative bacteria, which have become resistant to most available antibiotic treatments. Development of new antibiotics that are effective against such infections is critical to counter the public health crisis in hospitals everywhere, but especially in countries with a high burden of AMR.