BWC0977.
Advancing a new broad-spectrum treatment against serious hospital-acquired infections.
GARDP is partnering with Bugworks Research Inc. (“Bugworks”) to co-develop BWC0977 intravenous (IV) and oral formulations . It is a novel candidate antibiotic with activity against critical- and high-priority pathogens on WHO’s priority pathogens list, including difficult-to-treat carbapenem-resistant Acinetobacter baumannii, Klebsiella pneumoniae and Pseudomonas aeruginosa.
What is BWC0977 and how does it work?
BWC0977 is a pyrazino-oxazinone class antibacterial with broad-spectrum activity against both Gram-positive and Gram-negative pathogens. It targets both, DNA gyrase and topoisomerase IV, thus interfering with bacterial DNA replication. Because of the way BWC0977 binds to these DNA replication enzymes it may have lower potential for cross-resistance with known antibiotic classes.
GARDP’s role in advancing BWC0977.
GARDP is providing technical and financial support to Bugworks to advance the development of BWC0977 in both IV and oral formulations.
GARDP’s initial support for pharmaceutical development included product formulation, which is being followed by support for clinical development and chemistry, manufacturing and controls (CMC) activities. This end-to-end approach is designed to ensure that the final product is robust, affordable and suitable for use in a wide range of countries and contexts, including low-resource settings.
The potential impact
At the time that GARDP and Bugworks signed the agreement for the co-development of BWC0977 IV formulation in May 2024, BWC0977’s first in human trials (phase 1) clinical development was being supported by CARB-X. By providing critical support at this relatively early stage in drug development, GARDP ensures that BWC0977’s development aligns with global public health needs and includes access as a critical component from the get-go. In June 2025 GARDP and Bugworks expanded the agreement to include the co-development of BWC0977 oral formulation.
As part of this, GARDP holds manufacturing and commercialization rights for IV and oral formulations of BWC0977 in 146 countries, almost all of which are low- and middle-income countries (LMICs).
Rights in 146 countries
Where does the project stand today?
The IV formulation is currently undergoing a phase 1 trial. IV formulations are well suited for use in hospital environments where patients with serious, drug-resistant infections require urgent, effective care.
At the same time, preparations for the oral formulation to enter a phase 1 clinical trial are ongoing. This version will offer a much-needed step-down option from IV therapy, especially vital for last-mile settings. It also has the potential, with proper stewardship, to serve as a stand-alone treatment in low-resource settings for patients battling extensively drug-resistant serious bacterial infections. Oral treatments for extensively drug-resistant Gram-negative infections are a global unmet medical need.
Key milestones
Signed
2024 – GARDP signed the collaboration and license agreement with Bugworks to develop an intravenous form of the investigational compound BWC0977.
SIGNED
2025 – GARDP signed the collaboration agreement with Bugworks to include the oral form of BWC0977.
ONGOING
2024 to present – GARDP is providing technical and financial support to Bugworks for the co-development of BWC0977. GARDP was involved in the development of a new BWC0977 IV formulation currently being tested in the ongoing phase 1 IV trial, and also for a new oral formulation to be used in the upcoming phase 1 oral trial.
Resources
Bugworks and GARDP collaborate to accelerate development of novel antibiotic to treat serious infections
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GARDP and Bugworks join forces to accelerate development of a novel antibiotic to treat serious bacterial infections
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