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BELLUS Health provides update on KIACTA(TM) Phase III orphan drug study
-   KIACTA™ Study Expected to Conclude Earlier than Anticipated - LAVAL...
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n- KIACTA™ Study Expected to Conclude Earlier than Anticipated - \n\n\nLAVAL, QC, Jan. 9, 2014 /CNW/ - BELLUS Health Inc. (TSX: BLU) (\"BELLUS\n Health\" or the \"Company\"), a drug development company focused on rare\n diseases, today announced an update on the ongoing Phase III study for\n KIACTA™, a drug candidate for patients with AA amyloidosis.\n\n\nThe Phase III Confirmatory Study is designed to confirm the safety and\n efficacy of KIACTA™, previously demonstrated in a Phase II/III study,\n in preventing kidney function decline in patients diagnosed with AA\n amyloidosis. AA amyloidosis is an orphan indication resulting in kidney\n dysfunction that often rapidly leads to dialysis and death.\n\n\nThe study is expected to enroll approximately 230 patients from more\n than 70 sites in 30 countries worldwide. To date, the study has\n enrolled approximately 200 patients.  Enrollment is expected to be\n completed in the second quarter of 2014.\n\n\nThe study is an event-driven clinical trial that will conclude when 120\n patients have experienced an event linked to deterioration of kidney\n function. An event is counted when a patient's kidney function has\n deteriorated as measured by a persistent 80 per cent increase in serum\n creatinine, a persistent 40 per cent decrease in creatinine clearance\n or reaching end stage renal disease.\n\n\nTo date, more than 40 patients have had an event. Based on current\n recruitment and event rates, the KIACTA™ Phase III Confirmatory Study\n is now expected to conclude in 2016, rather than BELLUS Health's\n previous guidance of 2017.\n\n\n\"We are excited about these earlier timelines because it brings KIACTA™\n closer to potentially becoming the first approved therapy for AA\n amyloidosis patients,\" said Roberto Bellini, President and Chief\n Executive Officer of BELLUS Health.\n\n\nAbout KIACTA™ for AA Amyloidosis\n\n\nKIACTA™ is an orally bioavailable small molecule intended for the\n treatment of AA amyloidosis, an orphan indication that often rapidly\n leads to dialysis and death.\n\n\nKIACTA™ is partnered with global private equity firm Auven Therapeutics\n who is responsible for conducting and paying for the currently ongoing\n Phase III Confirmatory Study. Patient recruitment is ongoing and is\n expected to be ...