- KIACTA™ Study Expected to Conclude Earlier than Anticipated -
LAVAL, QC, Jan. 9, 2014 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company"), a drug development company focused on rare diseases, today announced an update on the ongoing Phase III study for KIACTA™, a drug candidate for patients with AA amyloidosis.
The Phase III Confirmatory Study is designed to confirm the safety and efficacy of KIACTA™, previously demonstrated in a Phase II/III study, in preventing kidney function decline in patients diagnosed with AA amyloidosis. AA amyloidosis is an orphan indication resulting in kidney dysfunction that often rapidly leads to dialysis and death.
The study is expected to enroll approximately 230 patients from more than 70 sites in 30 countries worldwide. To date, the study has enrolled approximately 200 patients. Enrollment is expected to be completed in the second quarter of 2014.
The study is an event-driven clinical trial that will conclude when 120 patients have experienced an event linked to deterioration of kidney function. An event is counted when a patient's kidney function has deteriorated as measured by a persistent 80 per cent increase in serum creatinine, a persistent 40 per cent decrease in creatinine clearance or reaching end stage renal disease.
To date, more than 40 patients have had an event. Based on current recruitment and event rates, the KIACTA™ Phase III Confirmatory Study is now expected to conclude in 2016, rather than BELLUS Health's previous guidance of 2017.
"We are excited about these earlier timelines because it brings KIACTA™ closer to potentially becoming the first approved therapy for AA amyloidosis patients," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health.
About KIACTA™ for AA Amyloidosis
KIACTA™ is an orally bioavailable small molecule intended for the treatment of AA amyloidosis, an orphan indication that often rapidly leads to dialysis and death.
KIACTA™ is partnered with global private equity firm Auven Therapeutics who is responsible for conducting and paying for the currently ongoing Phase III Confirmatory Study. Patient recruitment is ongoing and is expected to be completed in the second quarter of 2014. The Phase III Confirmatory Study is an event driven trial that is expected to conclude in 2016. The study will be used to confirm the positive safety and efficacy results shown in the Phase II/III study previously conducted by BELLUS Health.
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, 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 rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics.
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 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 the BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, and 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 KIACTATM Phase III Confirmatory Study is dependent upon many factors including clinical sites activation, patient enrolment rate, 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. is under no obligation and disavows 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.'s public fillings including the Annual Information Form for further risk factors that might affect BELLUS Health Inc. and its business.
SOURCE: BELLUS Health Inc.
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