NEW YORK & LAVAL, Canada--(BUSINESS WIRE)--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.
Forward Looking Statements
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s and Auven Therapeutics’ control. Such risks include but are not limited to: the ability to obtain financing, the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which BELLUS Health Inc. and Auven Therapeutics do business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments in relation to indemnity agreements, achievement of forecasted clinical trial milestones, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. The length of the KIACTATM Phase III Confirmatory Study is dependent upon many factors including patient drop-out rate and occurrence of clinical endpoint events. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These statements speak only as of the date made and BELLUS Health Inc. and Auven Therapeutics are under no obligation and disavow any intention to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health Inc. public fillings including the Annual Information Form for further risk factors that might affect BELLUS and its business.