Auven Therapeutics & Bellus Health Announce Completion of Enrollment in the Phase III Confirmatory Study of Kiacta™ for the...
May 27 2014 - 5:00PM
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.
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Auven TherapeuticsMedia enquiries:Instinctif PartnersSue
Charles/Stefanie Bacher/Gemma HoweT: +44 (0)20 7866
7866auventx@instinctif.comorInvestor Relations:Kathy
Armstrong:kathy.armstrong@auventx.comorBELLUS HealthAdam
PeelerTMX EquicomT: +1 416-815-0700 ext.
225apeeler@tmxequicom.com
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