[February 12, 2018] |
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Akebia Therapeutics Provides Update on Vadadustat Development Program
Akebia
Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company
focused on delivering innovative therapies to patients with kidney
disease through the biology of hypoxia-inducible factor (HIF), today
provided an update on the global development plan for vadadustat, an
oral HIF stabilizer in global Phase 3 development for the treatment of
anemia due to chronic kidney disease.
"We continue to execute on our global Phase 3 program for vadadustat.
Patient enrollment in INNO2VATE and PRO2TECT is
advancing, with full enrollment of these studies targeted by the end of
2018," said John P. Butler, President and Chief Executive Officer of
Akebia Therapeutics. "We anticipate top-line results for INNO2VATE
and PRO2TECT in 2019, subject to the accrual of MACE events,
with market launch anticipated in 2020."
"In collaboration with our partner, Otsuka," added Butler, "we have
enhanced the study designs for FO2RWARD and TRILO2GY.
We believe these changes will provide additional characterization and
differentiation of vadadustat and further strengthen our commercial
position upon the drug's approval. The investment in these study
enhancements reflects our confidence in the program and our desire to
position vadadustat for success upon launch."
Vadadustat Development Program Updates:
INNO2VATE and PRO2TECT Phase 3 Programs
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Full enrollment targeted by the end of 2018
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Top-line results expected in 2019, subject to the accrual of MACE
events
FO2RWARD Phase 2 Study
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New study design includes a broader dialysis population in addition to
hyporesponders, and a larger sample size; this study will replace the
former FO2RWARD study
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Includes once-daily and three-times-weekly dosing
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Designed to generate data to inform ESA-switching protocols
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Expected to initiate in Q2 2018, with top-line results expected in
late 2018 or early 2019
TRILO2GY Phase 3 Study
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New study design includes once-daily and three-times-weekly dosing and
an ESA control, as well as a larger sample size; this study will
replace the former TRILO2GY study
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Designed to generate data to inform switching from Epogen®
(epoetin alfa), Aranesp® (darbepoetin alfa) and Mircera®
(methoxy PEG-epoetin beta)
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Expected to initiate in late 2018 or early 2019, with top-line results
expected in early 2020
Japan Phase 3 Program
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Akebia's partner, Mitsubishi (News - Alert) Tanae Pharma Corporation, initiated its
Phase 3 program to support registration in patient populations with
anemia due to non-dialysis-dependent and dialysis-dependent chronic
kidney disease
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These studies do not include a MACE endpoint
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Data read-out expected in 2019
Non-Clinical Carcinogenicity Studies
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Akebia completed two carcinogenicity studies, a two-year study in rats
and a six-month study in mice, results of which showed no carcinogenic
effect of vadadustat
About Vadadustat Vadadustat is an oral hypoxia-inducible
factor (HIF) stabilizer currently in Phase 3 development for the
treatment of anemia related to chronic kidney disease. Vadadustat
exploits the same mechanism of action used by the body to adapt
naturally to lower oxygen availability associated with a moderate
increase in altitude. At higher altitudes, the body responds to lower
oxygen availability with increased production of HIF, which coordinates
the interdependent processes of iron mobilization and erythropoietin
production to increase red blood cell production and, ultimately,
improve oxygen delivery. Vadadustat is an investigational therapy not
approved by the U.S. Food and Drug Administration or any regulatory
authority.
About Akebia Therapeutics Akebia Therapeutics, Inc. is a
biopharmaceutical company headquartered in Cambridge, Massachusetts,
focused on delivering innovative therapies to patients with kidney
disease through hypoxia-inducible factor biology. For more information,
please visit our website at www.akebia.com,
which does not form a part of this release.
Forward-Looking Statements Statements in this press release
regarding Akebia's strategy, plans, prospects, expectations, beliefs,
intentions or goals are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended,
including but not limited to statements regarding the rate and timing of
enrollment, including full enrollment, of our clinical trials; the
timing, availability and presentation of clinical trial data and
results; the benefits, including the potential effect on commercial
position, of the designs of our studies; the execution of our global
Phase 3 program for vadadustat; the timing of market launch of
vadadustat; the potential characterization and differentiation
information we believe will result from the designs of our studies;
positioning vadadustat for success upon launch; replacing the former FO2RWARD
and the former TRILO2GY with new study designs; the timing of
initiation of our clinical trials; and the potential of FO2RWARD
and TRILO2GY to generate data to inform switching. The terms
"advance," "anticipate," "believe," "continue," "design," "desire,"
"enhance," "expect," "expectation," "target," "will," "would" and
similar expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying
words. Each forward-looking statement is subject to risks and
uncertainties that could cause actual results to differ materially from
those expressed or implied in such statement, including the rate of
enrollment in clinical studies of vadadustat; the risk that clinical
trials may not be successful; the risk that existing preclinical and
clinical data may not be predictive of the results of ongoing or later
clinical trials; manufacturing risks; the quality and manner of the data
that will result from clinical studies of vadadustat; the actual funding
required to develop and commercialize Akebia's product candidates and
operate the company, and the actual expenses associated therewith; the
actual costs incurred in the clinical studies of vadadustat and the
availability of financing to cover such costs; the risk that clinical
studies need to be discontinued for any reason, including for safety,
tolerability, enrollment, manufacturing or economic reasons; early
termination of any of Akebia's collaborations; Akebia's and its
collaborators' ability to satisfy their obligations under Akebia's
collaboration agreements; the timing and content of decisions made by
regulatory authorities; the timing of any additional studies initiated
for vadadustat; the actual time it takes to initiate and complete
research and clinical studies; the success of competitors in developing
product candidates for diseases for which Akebia is currently developing
its product candidates; the scope, timing, and outcome of any ongoing
legal proceedings; changes in the economic and financial conditions of
the businesses of Akebia and its partners; and Akebia's ability to
obtain, maintain and enforce patent and other intellectual property
protection for vadadustat and its other product candidates. Other risks
and uncertainties include those identified under the heading "Risk
Factors" in Akebia's Quarterly Report on Form 10-Q for quarter ended
September 30, 2017, and other filings that Akebia may make with the U.S.
Securities and Exchange Commission in the future. These forward-looking
statements (except as otherwise noted) speak only as of the date of this
press release, and Akebia does not undertake, and specifically
disclaims, any obligation to update any forward-looking statements
contained in this press release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180212005235/en/
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