BELLUS Health and Celtic Therapeutics announced that a global confirmatory Phase 3 study was initiated for their orphan status drug, Kiacta (eprodisate), for the treatment of Amyloid A (AA) amyloidosis. AA amyloidosis is a life-threatening disease that occurs in patients with long-lasting inflammatory conditions, most commonly due to rheumatoid arthritis. The international, randomized, double-blind, placebo-controlled, event-driven study will involve approximately 230 patients enrolled from approximately 90 sites in 30 countries worldwide. The primary efficacy composite endpoint of the study is based on patients reaching an event linked to the deterioration of their renal function, defined as a persistent decrease in creatinine clearance (CrCl) of 40% or more, a persistent increase in serum creatinine (SCr) of 80% or more, or progression to end-stage renal disease (ESRD). The primary efficacy analysis will be the time from baseline to the first renal deterioration event of the primary composite endpoint.
Kiacta is an oral investigational product being developed for the treatment of AA amyloidosis. This disease is caused by the build-up of insoluble ‘fibrils’ (fine threads) of ‘amyloid A’ (AA) proteins in the organs of the body. It is expected that Kiacta interferes with the formation of AA fibrils, thus preventing the deposits from building up in the organs.
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