BELLUS Health Inc. (TSX: BLU) and Celtic Therapeutics announced today that a global confirmatory phase III clinical study was initiated on December 14, 2010 for KIACTA™ (eprodisate). KIACTA™ is a drug candidate being developed for the treatment of AA amyloidosis, a life-threatening orphan disease that occurs in patients with long-lasting inflammatory conditions, most commonly due to rheumatoid arthritis. The study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients with AA amyloidosis.
"KIACTA™ has the potential to offer a much awaited treatment to patients with AA amyloidosis, a devastating disease affecting an estimated 50,000 patients in the United States, Europe and Japan, for which there is currently no specific treatment available," said Dr. Peter B. Corr, Co-Founder and General Partner of Celtic Therapeutics. "In its initial phase III clinical study, KIACTA™ reduced the risk of renal decline or mortality by 42% (Cox proportional hazards regression model, Dr. Corr added.
"We are pleased to see KIACTA™ advancing to a confirmatory phase III clinical study so quickly and are delighted that leading investigators throughout the world are eager to participate in this important trial", said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "As agreed upon with the US Food and Drug Administration (FDA) in a Special Protocol Assessment (SPA) and the European Medicines Agency (EMEA), this confirmatory study represents the last key step before applications for regulatory approval for KIACTA™ can be filed. The initiation of this registration trial is positive news for patients with AA amyloidosis and represents an important milestone for BELLUS Health and its shareholders," Mr. Bellini concluded.