Blade Therapeutics Announces Initiation of Phase 1 Study of Lead Calpain Inhibitor BLD-2660 for Fibrosis
The first-in-human Phase 1, placebo controlled, dose escalation trial is evaluating the safety and pharmacokinetics (PK) profile of orally administered BLD-2660, a selective small molecule dimeric calpain inhibitor, in healthy volunteers. This study is being conducted in Australia with initial results from healthy volunteers expected by the fourth quarter of 2018.
“We are excited to initiate clinical development with BLD-2660. This represents a major milestone for the Company,” stated Blade’s Chief Executive Officer, Wendye Robbins, M.D. “BLD-2660 has shown remarkable anti-fibrotic properties in multiple preclinical disease models. We believe it will be an effective treatment option with a favorable safety profile for patients suffering from debilitating fibrotic diseases. By initiating the clinical trial in Australia, we are able to expedite our development timelines, work with top clinicians, and take advantage of favorable government rebates. We plan to file a U.S. Investigational New Drug Application (IND) with human safety and PK data by the end of the year, which we anticipate will allow us to move BLD-2660 into human proof-of-concept studies in 2019.”
BLD-2660 is an optimized small molecule inhibitor of dimeric calpains. Calpains are non-lysosomal calcium dependent proteases. BLD-2660 is a best-in-class calpain inhibitor with robust anti-fibrotic activity in vivo. In biochemical studies, BLD-2660 exhibited potent and selective inhibition of calpains 1,2, and 9. BLD-2660 also proved to be efficacious in multiple animal models of pulmonary, skin, and liver fibrosis. BLD-2660 exhibited high selectivity against related cysteine proteases, high metabolic stability, and a favorable pharmacokinetic profile in preclinical species following oral and intravenous administration.
BLD-2660 was developed by leveraging insights from Johns Hopkins University School of Medicine (Laboratory of Hal Dietz, M.D.) to discover new therapeutic approaches that can broadly modulate fibrosis, and thereby contribute to the treatment of diverse diseases.
About Blade Therapeutics
Blade Therapeutics is a private, clinical-stage biopharmaceutical company advancing novel anti-fibrotic therapies to meet important patient needs. Blade’s lead compound, BLD-2660, is a highly selective calpain inhibitor targeted for the treatment of chronic fibrotic diseases. BLD-2660 is currently in a first-in-human Phase 1 clinical trial in Australia, and Blade anticipates filing a US IND by the end of 2018. Blade has assembled a critical mass of anti-fibrotic drug development expertise within its top-tier leadership team and world-class network of advisors. Lead investors in Blade include MPM Capital, Deerfield, Osage Partners, Bristol-Myers Squibb, Novartis Institute of Biomedical Research, as well as the venture fund of Pfizer. Please visit http://www.blademed.com/ for more information.
Source: Blade Therapeutics