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Auven Therapeutics and BELLUS Health announce completion of enrollment in the Phase III Confirmatory Study of KIACTA(TM) for the treatment of AA amyloidosis

NEW YORK, USA and LAVAL, CANADA , May 27, 2014 /CNW/ -  Auven Therapeutics, the g...

articleBluenergies Ltd.May 27, 20145/company/bluenergies-ltd/news/auven-therapeutics-and-bellus-health-announce-completion-of-enrollment-in-the-phase-iii-confirmatory-study-of-kiactatm-for-the-treatment-of-aa-amyloidosis
Auven Therapeutics and BELLUS Health announce completion of enrollment in the Phase III Confirmatory Study of KIACTA(TM) for the treatment of AA amyloidosis

About this update from Bluenergies Ltd.

[{"type":"text","content":"\n\n\nNEW YORK, USA and LAVAL, CANADA, May 27, 2014 /CNW/ -  Auven\n Therapeutics, the global private equity company focused on accelerated\n development of breakthrough therapeutic drugs and BELLUS Health Inc.\n (TSX: BLU), a drug development company focused on rare diseases, today\n announced that the KIACTA™ Phase III Confirmatory Study in AA\n amyloidosis (an orphan indication) has completed its targeted\n enrollment of 230 patients. Eligible patients currently in screening\n will also be given the opportunity to enroll in the study likely\n increasing total recruitment beyond 230 patients.\n\n\nThe Phase III Confirmatory Study is a randomized, double-blind,\n placebo-controlled study to evaluate the safety and efficacy of KIACTA™\n in preventing renal function decline in patients with AA amyloidosis,\n which results in chronic renal failure, dialysis and death. The\n objective of the study is to confirm the safety and efficacy shown in a\n previously conducted Phase II/III study. The study is an event-driven\n clinical trial that will conclude when 120 patients have experienced an\n event linked to deterioration of kidney function. To date, over 60\n patients have had an event. Based on the current event rate, the\n KIACTA™ Phase III Confirmatory Study is expected to be completed in\n 2016.\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 leads to\n dialysis and death. KIACTA™ was originally developed by BELLUS Health.\n Auven Therapeutics acquired worldwide rights related to KIACTA™ from\n BELLUS Health in 2010 and is responsible for conducting and financing\n the KIACTA™ development program. Auven Therapeutics and BELLUS Health\n expect to share overall proceeds from a KIACTA™ divestiture equally,\n assuming that total divestment transaction proceeds reach a\n pre-determined threshold. Proceeds will be shared between Auven\n Therapeutics and BELLUS Health based on a formula that provides for\n Auven Therapeutics to have certain preference rights on exit proceeds\n related to their investment costs in KIACTA™.\n\n\nAbout Auven Therapeutics (www.auventx.com)\n\n\nAuven Therapeutics is a global private equity firm that acquires an...

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