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 and oral formulations). It is a novel investigational antibiotic with activity against all critical- and high-priority pathogens on WHO’s priority pathogens list, including hard-to-treat carbapenem-resistant Acinetobacter baumannii and Klebsiella pneumoniae.
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 binds to both DNA gyrase and topoisomerase IV, thus interfering with DNA replication. With an innovative mechanism of action, BWC0977 may have lower potential for cross-resistance than 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 in May 2024, BWC0977 was in phase 1 clinical development with support from CARB-X. By providing critical support at this relatively early stage in drug development, GARDP ensured that BWC0977’s development aligns with global public health needs and includes access as a critical component from the get-go.
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.
Rights in 146 countries
Where does the project stand today?
The IV formulation is currently undergoing a phase 1 trial. This formulation is well suited for use in hospital environments where patients with serious, drug-resistant infections require urgent, effective care.
On the other hand, the oral formulation is gearing up for a phase 1 clinical trial. 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.
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 for the phase 1 clinical trial of the BWC0977 intravenous formulation.
Resources
Bugworks and GARDP collaborate to accelerate development of novel antibiotic to treat serious infections
Read more
GARDP and Bugworks join forces to accelerate development of a novel antibiotic to treat serious bacterial infections
Read more