Akebia Therapeutics Provides Update on Vadadustat Development Program
February 12 2018 - 7:00AM
Business Wire
-- Targets Full Enrollment for INNO2VATE and
PRO2TECT by the End of 2018 --
-- Confirms Expectation of Top-Line Results for
INNO2VATE and PRO2TECT in 2019, Subject to Accrual of MACE Events
--
-- Enhances FO2RWARD and TRILO2GY Study Designs
for Commercial Optimization --
-- Confirms No Carcinogenic Effect in Two
Non-Clinical Carcinogenicity Studies --
-- Partner Mitsubishi Tanabe Pharma Corporation
Initiates Phase 3 NDD-CKD and DD-CKD Program in Japan --
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
- Full enrollment targeted by the end of
2018
- Top-line results expected in 2019,
subject to the accrual of MACE events
FO2RWARD Phase 2 Study
- 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
- Includes once-daily and
three-times-weekly dosing
- Designed to generate data to inform
ESA-switching protocols
- Expected to initiate in Q2 2018, with
top-line results expected in late 2018 or early 2019
TRILO2GY Phase 3 Study
- 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
- Designed to generate data to inform
switching from Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa)
and Mircera® (methoxy PEG-epoetin beta)
- Expected to initiate in late 2018 or
early 2019, with top-line results expected in early 2020
Japan Phase 3 Program
- Akebia’s partner, Mitsubishi Tanabe
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
- These studies do not include a MACE
endpoint
- Data read-out expected in 2019
Non-Clinical Carcinogenicity Studies
- 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 VadadustatVadadustat 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 TherapeuticsAkebia 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 StatementsStatements 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20180212005235/en/
Media:Akebia Therapeutics, Inc.John Garabo,
617-844-6130Director, Corporate
Communicationsjgarabo@akebia.comorInvestor Relations:Argot
PartnersMelissa Forst, 212-600-1902akebia@argotpartners.com
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