The randomized, placebo-controlled, dose-escalation Phase 1 trial (NCT03559166) is enrolling an estimated 88 healthy volunteers to assess the safety and pharmacokinetics — how the drug is absorbed, distributed, metabolized, and eliminated from the body — of oral BLD-2660. It is currently recruiting participants.
“We are excited to initiate clinical development with BLD-2660. This represents a major milestone for the Company,” Wendye Robbins, MD, Blade’s CEO, said in a press release. “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.”
Fibrosis is a condition caused by the excessive formation and accumulation of connective tissue in an organ — also known as scarring — which can interfere with the organ’s normal structure and function.
Fibrosis can affect several organs, including the lungs, liver, and skin, and is often accompanied by local inflammation. As a result, several therapies aimed at controlling and reducing tissue inflammation have been developed in an effort to improve patients’ quality of life.
BLD-2660 is one such therapy in development. The compound is a highly selective inhibitor of calpains — a family of enzymes called proteases that play an important role in protein degradation and also regulate inflammation, cell migration, and other important processes.
In previous preclinical studies, BLD-2660 exhibited strong anti-fibrotic activity in multiple animal models of pulmonary, skin, and liver fibrosis. Moreover, biochemical analyses revealed that BLD-2660 had high metabolic stability and a favorable pharmacokinetic profile when administered orally or directly into the vein.
The trial will be conducted in Australia, with the first results expected by the end of 2018.
“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,” Robbins said. “We plan to file a U.S. Investigational New Drug Application (IND) with human safety and PK [pharmacokinetic] 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.”