LAVAL, QC, June 20, 2016 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company"), a drug development company focused on rare diseases, today announced top-line results from the Phase 3 study of KIACTA™ (eprodisate) for the treatment of AA amyloidosis.
In the study, KIACTA™ did not meet the primary efficacy endpoint in slowing renal function decline. KIACTA™ was shown to be safe and well tolerated over treatment periods of greater than 4 years. Further analysis of the data is ongoing.
"While we are disappointed that the Phase 3 study did not meet the primary efficacy endpoint, the full data set will be assessed to determine the best path forward," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health.
AA amyloidosis is a rare disease secondary to severe chronic inflammation or infection leading to the formation and deposition of amyloid fibrils in organs, often resulting in end-stage renal disease and death. Currently there are no therapies available that target the disease directly.
The confirmatory Phase 3 study of KIACTA™ was a global study across more than 70 sites in more than 25 countries that randomized 261 patients to receive either 800mg dose of KIACTA™ twice daily or placebo. The Phase 3 study was an event driven study that lasted 5 years meeting its completion target of 120 patient events linked to the deterioration of kidney function in January 2016.
A more detailed data set of the KIACTA™ Phase 3 study will be presented July 6 at the XV International Symposium on Amyloidosis.
BELLUS Health is partnered with global private equity firm Auven Therapeutics for the development of KIACTA™. Auven Therapeutics acquired the rights to KIACTA™ from the Company in 2010.
About AA Amyloidosis
AA amyloidosis is a deadly condition that progresses from chronic inflammatory diseases such as rheumatoid arthritis. The disease causes a protein called amyloid A to accumulate in major organs, particularly the kidneys, which leads to organ dysfunction, failure, and eventually death.
There is currently no available treatment for AA amyloidosis. A recent commercial assessment study conducted by Navigant Consulting on behalf of Auven Therapeutics and BELLUS Health identified between 10,000 and 15,000 KIACTA™ eligible patients with AA amyloidosis in the United States and Europe.
KIACTA™ has been granted Orphan Drug designation or its equivalent for the treatment of AA amyloidosis in the United States, Europe and Japan, which provide for market exclusivity for a period of seven to ten years once the drug is approved, as well as a reduction in application and review fees.
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 3 for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage Shigamab™ for STEC-related Hemolytic Uremic Syndrome (sHUS) and a research-stage project for AL amyloidosis.
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" within the meaning of Canadian securities legislation and regulations. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks factors 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. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity agreements and contingent value rights, achievement of forecasted pre-clinical and clinical trial milestones, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of the KIACTATM Phase 3 Confirmatory Study and the sharing of proceeds between Auven Therapeutics and BELLUS Health Inc. from potential future revenue of KIACTA™ are dependent upon a number of factors, including the quantum of proceeds. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. BELLUS Health Inc. believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health Inc. is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health Inc.'s public filings with the Canadian securities regulatory authorities, 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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