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