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.
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( With inputs from ANI )
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