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Auven Therapeutics: Auven Therapeutics and Bellus Health Announce Completion of Pivotal Phase 3 Confirmatory Trial of KIACTA(TM) for the Treatment of Orphan Di

Study Reached 120 Qualifying Events, Top-Line Results Expected in Q2 2016ST. THOMAS, U.S. Virgin Islands, LAUSANNE, Switzerland, HAMILTON, Bermuda and
LAVAL, Quebec, Jan. 21, 2016 (GLOBE NEWSWIRE) -- 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(TM) (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

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(TM) 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

"We designed this trial to confirm the results of the prior Phase 2/3 study in
which KIACTA(TM) 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(TM) for the treatment of AA
amyloidosis. Preclinical data also suggests KIACTA(TM) has potential to treat
other diseases, including sarcoidosis. In vitro study test results in
sarcoidosis indicate KIACTA(TM) 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(TM) 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

"We anticipate this trial will demonstrate conclusively KIACTA(TM)'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(TM) later this year," said Stephen
Evans-Freke, Co-Founder and Managing General Partner of Auven.

About KIACTA(TM) for AA Amyloidosis

KIACTA(TM) 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(TM) 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(TM)
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(TM) was originally developed by BELLUS Health. Auven Therapeutics
acquired worldwide rights related to KIACTA(TM) from BELLUS Health in 2010
and is responsible for conducting and financing the KIACTA(TM) development
program. Auven Therapeutics and BELLUS Health expect to share overall
proceeds from a KIACTA(TM) 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(TM).

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(TM) in Phase III for AA
amyloidosis, KIACTA(TM) for sarcoidosis, clinical stage Shigamab(TM) 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(TM) 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.

For Auven Therapeutics
Tony Plohoros
6 Degrees
(908) 591-2839

For BELLUS Health
Francois Desjardins
Vice President, Finance
BELLUS Health Inc.
(450) 680-4525


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Auven Therapeutics via Globenewswire


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