Bugworks Research Announces the First in Human Phase 1 Study of BWC0977 for the Treatment of Critical Bacterial Infections
PR92866
BANGALORE, India, SARATOGA, Calif. and ADELAIDE, Nov. 8, 2021 /PRNewswire=KYODO JBN/ --
Bugworks research today announced that the first human dose was
administered in a Phase 1 clinical trial evaluating BWC0977: a next generation
broad-spectrum, novel bacterial topoisomerase inhibitor (NBTI), supported by
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).
"Bugworks represents one of four CARB-X programs conducting First-in-Human
trials this year," said CARB-X Chief of R&D Dr. Erin Duffy. "We are proud to
have accelerated this program from a Lead Optimization campaign through to this
study to demonstrate safety and drug levels in healthy humans. '0977 has the
potential to cover a broad range of priority pathogens in the syndromes of high
unmet need."
BWC0977 is a highly potent, intravenous broad-spectrum antibiotic with the
potential for oral administration, for the treatment of serious multi drug
resistant (MDR) Gram-negative infections such as Acinetobacter baumannii,
Pseudomonas aeruginosa, carbapenemase producing Enterobacteriaceae, and drug
resistant Gram-positive infections such as methicillin resistant staphylococci
(MRSA), vancomycin resistant enterococci (VRE) and penicillin resistant
streptococci (PRSP). BWC0977 can address many serious hospital & community
infections and combat a broad spectrum of biothreat pathogens. It has the
potential of becoming a breakthrough antibiotic, not seen since the 1960's.
"The need for an effective and safe antibiotic against multiple MDR
pathogens is urgent," said Dr. Bala Subramanian, COO & Head of Discovery,
Bugworks. "We are extremely excited to move this into the clinic and closer to
patients. We believe that this novel broad-spectrum antibiotic will change the
landscape of treatment by enabling doctors to have a single-stop solution for
any bacterial infection. We are deeply thankful to CARB-X for its incredible
support throughout the preclinical and early clinical development of BWC0977."
BWC0977 is a product of sophisticated structure guided medicinal chemistry
led by Dr. Shahul Hameed, Chief Product Officer, Bugworks, engaging a
multi-continent collaborative partnership model. BWC0977, which emerged within
less than a hundred compounds synthesized, is active against clinical isolates
that are resistant to antibiotics currently in clinical use including
fluoroquinolones, carbapenems, cephalosporins, colistin etc., and is
efficacious in murine thigh, lung, and urinary tract infection models with
adequate safety margins in pre-clinical species.
"There is an urgent need for new antibiotics for the treatment of multidrug
resistant bacteria. BWC0977 is a promising new agent with activity against
drug resistant pathogens that are threatening the safety of patients and
healthcare systems throughout the world. The Antimicrobial Pharmacodynamics
and Therapeutics Laboratory at the University of Liverpool is very proud to
work with Bugworks to better understand how BWC0977 is best used for patients
that currently have severely limited treatment options." – Professor William
Hope, Dame Sally Davies Chair of AMR Research & Director Centre of Excellence
in Infectious Diseases Research, University of Liverpool
The Phase 1 clinical trial, ably led by Dr. Harish Kaushik, Clinical
Project Manager, is being conducted in Adelaide, Australia, after a positive
pre-IND meeting with the US FDA and with approval from HREC in Australia. This
trial is a randomized, double-blind, placebo-controlled study of the safety,
tolerability, and pharmacokinetics of single and multiple ascending doses of
BWC0977 in healthy adult subjects. Results are expected by early 2022.
Research reported in this press release is supported by CARB-X. CARB-X's
funding for this project is sponsored by the Cooperative Agreement Number
IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust and Germany's
Federal Ministry of Education and Research. The content is solely the
responsibility of the authors and does not necessarily represent the official
views of CARB-X or any of its funders.
About Bugworks (www.bugworksresearch.com)
Bugworks, a Delaware, Bangalore and Adelaide based biotech innovator is at
the forefront of the scientific innovation to deliver novel antibiotics, which
will address the alarming threat of anti-microbial resistance, which is
impacting millions of people today. Bugworks' solutions address the needs of
serious hospital & community infections, and biothreat indications.
Contact:
Anand Kumar
anand@bugworksresearch.com
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Photo: https://mma.prnewswire.com/media/1677851/Carbx_Bugworks.jpg
Source: Bugworks
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