Bugworks Research Announces First Human Phase 1 Study of BWC0977 for Treatment of Critical Bacterial Infections
BANGALORE from India; SARATOGA, California and ADÉLAIDEDE, Australia, November 8, 2021 / PRNewswire / – Bugworks research today announced that the first human dose has been delivered in a Phase 1 clinical trial evaluating BWC0977: a new, next-generation broad-spectrum bacterial topoisomerase (NBTI) inhibitor, supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).
“Bugworks is one of four CARB-X programs conducting human trials this year,” said Dr. Erin duffy. “We are proud to have accelerated this program from a lead optimization campaign to this study to demonstrate safety and drug levels in healthy humans. ‘0977 has the potential to cover a wide range of priority pathogens in high unmet need syndromes. “
BWC0977 is a very potent, broad-spectrum intravenous antibiotic that can be administered orally for the treatment of serious gram-negative multi-drug resistant (MDR) infections such as Acinetobacter baumannii, Pseudomonas aeruginosa, producing carbapenemase Enterobacteriaceae, and drug-resistant gram-positive infections such as methicillin resistant staphylococci (MRSA), vancomycin resistant enterococci (VRE) and penicillin resistant streptococci (PRSP). BWC0977 can treat many serious infections in hospital and community settings and combat a wide variety of biological pathogens. It has the potential to become a revolutionary antibiotic, never seen since the 1960s.
“The need for an effective and safe antibiotic against several MDR pathogens is urgent,” said Dr. Bala Subramanian, COO & Head of Discovery, Bugworks. “We are extremely excited to move this around the clinic and closer to the patients. We believe this new broad-spectrum antibiotic will change the treatment landscape by allowing physicians to have a one-stop solution for any bacterial infection. We are deeply grateful to CARB-X for their incredible support throughout the preclinical and early clinical development of BWC0977. “
BWC0977 is a sophisticated medicinal chemistry product guided by a structure led by Dr. Shahul Hamid, Chief Product Officer, Bugworks, engaging a multicontinental collaborative partnership model. BWC0977, which has emerged in less than a hundred synthesized compounds, is active against clinical isolates resistant to antibiotics currently used clinically, including fluoroquinolones, carbapenems, cephalosporins, colistin, etc., and is effective in murine thigh, lung and urinary tract infections. models with adequate safety margins in preclinical 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 threaten the safety of patients and healthcare systems worldwide. the University of Liverpool is very proud to work with Bugworks to better understand how BWC0977 is best used for patients who currently have very limited treatment options. “- Professor Guillaume Hope, Dame Sally Davies Research Chair in Antimicrobial Resistance and Director of the Center of Excellence in Infectious Disease Research, University of Liverpool
The phase 1 clinical trial, competently led by clinical project leader Dr Harish Kaushik, is being conducted in Adelaide, Australia, after a positive pre-IND meeting with the US FDA and with the approval of HREC in Australia. This trial is a randomized, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and multiple increasing doses of BWC0977 in healthy adult subjects. The results are expected in early 2022.
The research reported in this press release is supported by CARB-X. CARB-X funding for this project is sponsored by ASPR / BARDA Cooperation Agreement Number IDSEP160030 and Awards from Wellcome Trust and germany Federal Ministry of Education and Research. The content is the sole responsibility of the authors and does not necessarily represent the official opinions of CARB-X or any of its funders.
About Bugworks (www.bugworksresearch.com)
Bugworks, a biotechnology innovator based in Delaware, Bangalore and Adelaide, is at the forefront of scientific innovation to deliver novel antibiotics, which will help fight the alarming threat of antimicrobial resistance, which affects millions of people today. Bugworks solutions meet the needs of serious infections in hospitals and communities, and indications for biomenace.