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.
About KIACTA™
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.
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" 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.