NEW YORK, NY, USA and LAVAL, Canada I May 27, 2014 I Auven Therapeutics, the global private equity company focused on accelerated development of breakthrough therapeutic drugs and BELLUS Health Inc. (TSX: BLU), a drug development company focused on rare diseases, today announced that the KIACTA™ Phase III Confirmatory Study in AA amyloidosis (an orphan indication) has completed its targeted enrollment of 230 patients. Eligible patients currently in screening will also be given the opportunity to enroll in the study likely increasing total recruitment beyond 230 patients.
The Phase III Confirmatory Study is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of KIACTA™ in preventing renal function decline in patients with AA amyloidosis, which results in chronic renal failure, dialysis and death. The objective of the study is to confirm the safety and efficacy shown in a previously conducted Phase II/III study. The study is an event-driven clinical trial that will conclude when 120 patients have experienced an event linked to deterioration of kidney function. To date, over 60 patients have had an event. Based on the current event rate, the KIACTA™ Phase III Confirmatory Study is expected to be completed in 2016.
About KIACTA™ for AA Amyloidosis
KIACTA™ is an orally bioavailable small molecule intended for the treatment of AA amyloidosis, an orphan indication that often leads to dialysis and death. KIACTA™ was originally developed by BELLUS Health. Auven Therapeutics acquired worldwide rights related to KIACTA™ from BELLUS Health in 2010 and is responsible for conducting and financing the KIACTA™ development program. Auven Therapeutics and BELLUS Health expect to share overall proceeds from a KIACTA™ divestiture equally, assuming that total divestment transaction proceeds reach a pre-determined threshold. Proceeds will be shared between Auven Therapeutics and BELLUS Health based on a formula that provides for Auven Therapeutics to have certain preference rights on exit proceeds related to their investment costs in KIACTA™.
About Auven Therapeutics (www.auventx.com)
Auven Therapeutics is a global private equity firm that acquires and pursues accelerated development of breakthrough therapeutic drugs prior to licensing them to commercial partners. Auven’s in-house team of senior pharmaceutical development executives establishes the clinical regulatory, manufacturing and commercial strategies for all its products and oversees their execution. Auven was founded in 2007 by Stephen Evans-Freke and Dr. Peter B. Corr and maintains operations in Lausanne, London, New York, Bermuda, and the U.S. Virgin Islands.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a drug development company focused on rare diseases. It has a portfolio of rare disease projects including KIACTA™ in Phase III for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage ShigamabTM for STEC-related Hemolytic Uremic Syndrome (sHUS) and a research-stage project for AL amyloidosis. The lead program KIACTA™ is currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death.
SOURCE: Bellus Health
Post Views: 178
NEW YORK, NY, USA and LAVAL, Canada I May 27, 2014 I Auven Therapeutics, the global private equity company focused on accelerated development of breakthrough therapeutic drugs and BELLUS Health Inc. (TSX: BLU), a drug development company focused on rare diseases, today announced that the KIACTA™ Phase III Confirmatory Study in AA amyloidosis (an orphan indication) has completed its targeted enrollment of 230 patients. Eligible patients currently in screening will also be given the opportunity to enroll in the study likely increasing total recruitment beyond 230 patients.
The Phase III Confirmatory Study is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of KIACTA™ in preventing renal function decline in patients with AA amyloidosis, which results in chronic renal failure, dialysis and death. The objective of the study is to confirm the safety and efficacy shown in a previously conducted Phase II/III study. The study is an event-driven clinical trial that will conclude when 120 patients have experienced an event linked to deterioration of kidney function. To date, over 60 patients have had an event. Based on the current event rate, the KIACTA™ Phase III Confirmatory Study is expected to be completed in 2016.
About KIACTA™ for AA Amyloidosis
KIACTA™ is an orally bioavailable small molecule intended for the treatment of AA amyloidosis, an orphan indication that often leads to dialysis and death. KIACTA™ was originally developed by BELLUS Health. Auven Therapeutics acquired worldwide rights related to KIACTA™ from BELLUS Health in 2010 and is responsible for conducting and financing the KIACTA™ development program. Auven Therapeutics and BELLUS Health expect to share overall proceeds from a KIACTA™ divestiture equally, assuming that total divestment transaction proceeds reach a pre-determined threshold. Proceeds will be shared between Auven Therapeutics and BELLUS Health based on a formula that provides for Auven Therapeutics to have certain preference rights on exit proceeds related to their investment costs in KIACTA™.
About Auven Therapeutics (www.auventx.com)
Auven Therapeutics is a global private equity firm that acquires and pursues accelerated development of breakthrough therapeutic drugs prior to licensing them to commercial partners. Auven’s in-house team of senior pharmaceutical development executives establishes the clinical regulatory, manufacturing and commercial strategies for all its products and oversees their execution. Auven was founded in 2007 by Stephen Evans-Freke and Dr. Peter B. Corr and maintains operations in Lausanne, London, New York, Bermuda, and the U.S. Virgin Islands.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a drug development company focused on rare diseases. It has a portfolio of rare disease projects including KIACTA™ in Phase III for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage ShigamabTM for STEC-related Hemolytic Uremic Syndrome (sHUS) and a research-stage project for AL amyloidosis. The lead program KIACTA™ is currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death.
SOURCE: Bellus Health
Post Views: 178
