- Data Confirms Findings from Previous Studies -
- Phase 3 Study in Japan Expected to Commence by Year-End 2017
- Akebia Provides Mitsubishi Tanabe with Option to Access Global
Phase 3 Vadadustat Data for Payments of up to $25 Million -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
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
announced positive top-line results from its Phase 2 study of vadadustat
in Japanese patients with anemia associated with non-dialysis-dependent
chronic kidney disease (NDD-CKD). The results confirm findings from
previous studies of vadadustat. By the end of 2017, the Company, in
collaboration with Mitsubishi Tanabe Pharma Corporation (MTPC), expects
to announce top-line data from a Phase 2 study of vadadustat in dialysis
patients with CKD and initiate a Phase 3 development program in
non-dialysis patients in Japan. In addition, Akebia announced a new
agreement with MTPC which grants MTPC an option to access data from
Akebia's global Phase 3 vadadustat program for payments to Akebia of up
to $25 million.
"We are pleased that the Phase 2 Japan results in NDD-CKD patients are
consistent with data from our prior studies and we anticipate that the
upcoming results in dialysis patients will provide further confirmation
of vadadustat's potential," said Rita Jain, M.D., Senior Vice President
and Chief Medical Officer of Akebia. "We look forward to the start of
the Phase 3 program in Japan and a potential launch of vadadustat by
MTPC in Japan in 2020."
The double-blind, placebo-controlled, dose-finding Phase 2 study was
designed to evaluate the efficacy, safety, and tolerability of orally
administered vadadustat in Japanese patients with anemia associated with
NDD-CKD. This 16-week study evaluated 51 patients during a 6-week
placebo-controlled, fixed-dose period and a 10-week active treatment,
dose adjustment and maintenance period.
The primary efficacy endpoint was mean hemoglobin change from baseline
to week 6 comparing vadadustat to placebo. Statistically significant
improvements in the primary endpoint were observed in the vadadustat
groups, 150mg, (p < 0.0045), 300mg, (p < 0.0001), and 600mg (p < 0.0001),
compared to placebo. The data indicate a dose-response for vadadustat.
The incidence of any adverse events during the 6-week
placebo-controlled, fixed-dose period in the vadadustat groups (150mg,
300mg, and 600mg) and placebo was 33%, 58%, 54%, and 36%, respectively.
During the 16-week study, the most common adverse events reported were
viral upper respiratory tract infection (12%) and hypertension (10%).
Serious adverse events were consistent with prior studies and included
13 in 11 patients. No deaths were reported.
Akebia expects to present the data at an upcoming scientific meeting and
publish the study results in a peer-reviewed journal.
Following consultation with the Japanese Pharmaceuticals and Medical
Devices Agency (PMDA), Akebia and MTPC agreed to pursue a local Phase 3
development program for vadadustat in Japan. The companies believe that
this strategy offers the potential for an accelerated path toward
approval of vadadustat in Japan. MTPC will be responsible for all costs
associated with the Phase 3 vadadustat program in Japan and expects to
submit a Japanese New Drug Application (JNDA) for vadadustat with an
anticipated launch in 2020.
"The local Japanese development strategy provides a clear and
potentially expedited path forward for vadadustat in this large and
growing market," said John P. Butler, President and Chief Executive
Officer of Akebia. "We are confident that MTPC is well positioned to
execute on a successful local Phase 3 program for vadadustat and a
regulatory submission in Japan sooner than had we included Japanese
patients in our global Phase 3 program. We are committed to ensuring
that vadadustat is able to realize its full potential and will continue
to work closely with MTPC to achieve this goal in Japan."
In December 2015, Akebia and MTPC signed a Collaboration Agreement for
vadadustat in Japan and certain other countries, which provided for
committed capital and potential milestone payments to Akebia.
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.
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. Akebia's lead product candidate, vadadustat, is an oral,
investigational therapy in development for the treatment of anemia
related to chronic kidney disease in both non-dialysis and dialysis
patients. Akebia's global Phase 3 program for vadadustat, which includes
the PRO2TECT studies for non-dialysis patients with anemia
secondary to chronic kidney disease and the INNO2VATE studies
for dialysis-dependent patients, is currently ongoing. In addition, the
Company has initiated the Phase 2 FO2RWARD study of
vadadustat in dialysis-dependent chronic kidney disease patients who are
hyporesponsive to erythropoiesis-stimulating agents (ESAs), and expects
to commence the Phase 3 TRILO2GY study to further evaluate a
three-times-weekly dosing regimen for vadadustat. For more information,
please visit our website at www.akebia.com.
This press release includes forward-looking statements. Such
forward-looking statements include those about Akebia's strategy, future
plans and prospects, including statements regarding the potential
commercialization of vadadustat in Japan if approved by regulatory
authorities, the potential indications and benefits of vadadustat, the
expected timing and results of clinical studies, and anticipated
financial contributions from MTPC under the Collaboration Agreement. The
words "anticipate," "appear," "believe," "estimate," "expect," "intend,"
"may," "plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," 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 risk that existing preclinical
and clinical data may not be predictive of the results of ongoing or
later clinical trials; the actual funding required to develop 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;
early termination of Akebia's Collaboration Agreement with MTPC;
Akebia's ability to satisfy its obligations under the Collaboration
Agreement; the timing and content of decisions made by the PMDA and
other regulatory authorities; the timing of any additional studies
initiated by Akebia or MTPC for vadadustat; the rate of enrollment in
clinical studies of 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; 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 Annual Report on Form 10-Q for quarter ended June 30, 2017,
and other filings that Akebia may make with the Securities and Exchange
Commission in the future. 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/20170926005537/en/
Theresa McNeely, 617-844-6113
Communications and Investor Relations
Source: Akebia Therapeutics, Inc.
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