Study reached 120 qualifying events, top-line
results expected in Q2 2016
ST. THOMAS, U.S. VIRGIN ISLANDS; LAUSANNE, SWITZERLAND; MADISON, NEW JERSEY; HAMILTON, BERMUDA; and LAVAL, CANADA, Jan. 21,
2016 /CNW/ - Auven Therapeutics, a 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 the
completion of the KIACTA™ (eprodisate) Phase 3 confirmatory study
for the treatment of AA amyloidosis. Top-line results are expected
to be announced in Q2 2016 after all remaining patients have
completed final study visits, all queries have been resolved based
on input from study sites and the database has been locked.
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. In prior clinical studies, KIACTA™ has
been shown to slow the decline of renal function in AA amyloidosis
patients by its ability to interfere with the formation of amyloid
fibrils A and the deposition of these fibrils in tissues.
"We designed this trial to confirm the results of the prior
Phase 2/3 study in which KIACTA™ demonstrated significant delays in
AA amyloidosis disease progression, in some cases for a number of
years," said Dr. Peter B. Corr,
Co-Founder and Managing General Partner of Auven. "We are very
pleased to complete this step in our pivotal study and look forward
to reviewing and announcing the top-line results during the second
quarter of 2016."
The five-year Phase 3 study completed enrollment in January 2015 with a total of 261 patients. In
January 2016, the event-driven study
met its completion target of 120 patient events linked to the
deterioration of kidney function. As all remaining patients have a
final study visit in the coming weeks, the final number of events
could increase.
Assuming that this Phase 3 study achieves its primary endpoint,
it will support global regulatory approvals for KIACTA™ for the
treatment of AA amyloidosis. Preclinical data also suggests KIACTA™
has potential to treat other diseases, including sarcoidosis. In
vitro study test results in sarcoidosis indicate KIACTA™ may reduce
SAA-induced inflammatory cytokine expression and the initiation of
a Phase 2b/3 study in this second orphan indication is expected in
2016.
"The KIACTA™ Phase 3 confirmatory study is the most
comprehensive study ever conducted in AA amyloidosis patients,"
said Roberto Bellini, President and
Chief Executive Officer of BELLUS Health. "We are excited that a
key portion of the study is complete and look forward to receiving
the top-line data."
"We anticipate this trial will demonstrate conclusively
KIACTA™'s potential to make a major impact in the lives of those
who currently have no other treatment options available to them,
and we look forward to commencing a formal sale process for KIACTA™
later this year," said Stephen
Evans-Freke, Co-Founder and Managing General Partner of
Auven.
About KIACTA™ for AA Amyloidosis
KIACTA™ is an oral therapy in development for the treatment of
AA amyloidosis, an orphan disease for which there is no currently
approved therapy available. AA amyloidosis is a progressive, severe
and potentially fatal condition that affects people with chronic
inflammatory diseases. Chronic inflammation and/or infection cause
amyloid deposits accumulating within internal organs resulting in
potential organ failure over time. KIACTA has been studied for its
ability to slow the decline of renal function in AA amyloidosis
patients by interfering with the formation of amyloid fibrils and
the deposition of these fibrils in tissues. KIACTA has received
Orphan Drug Status in the United
States for AA amyloidosis and Orphan Medicinal Product
designation for AA amyloidosis in Europe and Japan.
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, Ft. Lauderdale, 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 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. 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 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/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 III Confirmatory Study and the sharing of
proceeds between Auven Therapeutics and BELLUS Health Inc. from
potential future revenue of KIACTA™ is dependent upon a number of
factors including the quantum of proceeds. Consequently,
actual future results may differ materially from the anticipated
results expressed in the forward-looking statements. Auven
Therapeutics and BELLUS Health Inc. believe 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. and Auven Therapeutics are under no obligation
and disavow 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 including the Annual Information Form for further risk
factors that might affect BELLUS Health and its business.
SOURCE BELLUS Health Inc.