lundi 13 juillet 2020

Akebia Announces Positive Vadadustat Data Demonstrating No Clinically Significant Drug-Drug Interaction

Par Rédaction , dans Communiqués , le 23 mai 2016

Monday, May 23rd 2016 at 11:00am UTC

– Results of CYP2C9 Analysis Presented at ERA-EDTA Annual Meeting –

CAMBRIDGE, Mass.–(BUSINESS WIRE)– 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
presented positive results from a drug-drug interaction study of
vadadustat, the Company’s oral therapy for the treatment of anemia
related to chronic kidney disease (CKD). The study demonstrated that
vadadustat has no clinically significant interaction with
CYP2C9-sensitive substrates and, therefore, may be administered with
medications metabolized by CYP2C9 without the need to modify the dose of
the co-administered drug. CYP2C9 is involved in the metabolism of many
commonly prescribed drugs, such as cholesterol and blood pressure
medications. These results were presented at the 53rd
European Renal Association-European Dialysis and Transplant Association
(ERA-EDTA) Congress in Vienna, Austria.

“These findings suggest that dose-modifications are not necessary when
medications commonly prescribed to patients with kidney disease that are
metabolized by CYP2C9 are taken concomitantly with vadadustat,”
stated Brad Maroni, Chief Medical Officer of Akebia. “The area under the
concentration-time curve (AUC) for celecoxib, a sensitive CYP2C9
substrate, was similar in the presence or absence of vadadustat, which
supports vadadustat as a potential best-in-class treatment for patients
with CKD.”

The data are from an open-label, single-sequence, drug-interaction study
in 12 healthy male volunteers who received a single, oral 200 mg dose of
celecoxib, a CYP2C9 substrate, on Day 1. Oral 600 mg doses of vadadustat
were then administered on Days 3 through 9 with an additional single
dose of celecoxib administered on Day 8. Serial blood samples were
collected over a 48-hour period to determine the concentrations of
celecoxib when administered alone on Day 1 and when co-administered with
vadadustat on Day 8.

The mean half-life of celecoxib was comparable when administered with
(10.3 hr) and without (10.8 hr) vadadustat. Co-administration of
vadadustat and celecoxib resulted in a 12% and 11% increase in celecoxib
AUC0-t and AUC0-inf, respectively. Based on the
90% confidence intervals for the geometric mean ratios for AUC0-t and
AUC0-inf, no significant drug-drug interaction was observed
between vadadustat and celecoxib. Vadadustat was well-tolerated when
administered with celecoxib, and importantly, vadadustat may be
administered with medications metabolized by CYP2C9, such as losartan
and rosuvastatin, without the need to modify the dose of the
co-administered drug.

The poster is available on the Akebia website at

About Vadadustat

Vadadustat is an oral therapy currently in development for the treatment
of anemia related to CKD. Vadadustat is designed to stabilize HIF, a
transcription factor that regulates the expression of genes involved
with red blood cell (RBC) production in response to changes in oxygen
levels, by inhibiting the hypoxia-inducible factor prolyl hydroxylase
(HIF-PH) enzyme. Vadadustat exploits the same mechanism of action used
by the body to naturally adapt 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 (EPO) production to increase RBC production and,
ultimately, improve oxygen delivery.

As a HIF stabilizer with best-in-class potential, vadadustat raises
hemoglobin levels predictably and sustainably, with a dosing regimen
that allows for a gradual and controlled titration. Vadadustat has been
shown to improve iron mobilization, potentially eliminating the need for
intravenous iron administration and reducing the overall need for iron

About Anemia Related to CKD

Approximately 30 million people in the United States have CKD, with an
estimated 1.8 million of these patients suffering from anemia. Anemia
results from the body’s inability to coordinate RBC production in
response to lower oxygen levels due to the progressive loss of kidney
function, which occurs in patients with CKD. Left untreated, anemia
significantly accelerates patients’ overall deterioration of health with
increased morbidity and mortality. Renal anemia is currently treated
with injectable recombinant ESAs, which are associated with inconsistent
hemoglobin responses and well-documented safety risks.

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 (HIF)
biology. Akebia has completed Phase 2 development of its lead product
candidate, vadadustat (formerly AKB-6548), an oral therapy for the
treatment of anemia related to chronic kidney disease (CKD) in both
non-dialysis and dialysis patients. Enrollment in the PRO2TECT
Phase 3 program in non-dialysis dependent patients commenced in late
2015 and the INNO2VATE Phase 3 program in dialysis dependent
patients is expected to commence in 2016. Akebia’s second product
candidate, AKB-6899, is expected to commence clinical development in
2016. For more information, please visit our website at

Forward-Looking Statements

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
indications and benefits of vadadustat. 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
ability of Akebia to successfully complete the clinical development of
vadadustat; the funding required to develop Akebia’s product candidates
and operate the company, and the actual expenses associated therewith;
the cost of the Phase 1 study of AKB-6899 and the Phase 3 studies of
vadadustat and the availability of financing to cover such costs; the
timing and content of decisions made by the FDA and other regulatory
authorities; the rate of enrollment in clinical studies of vadadustat
and AKB-6899; the actual time it takes to prepare for and initiate
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. Other
risks and uncertainties include those identified under the heading “Risk
Factors” in Akebia’s Annual Report on Form 10-Q for the quarter ended
March 31, 2016, 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.


Argot Partners
Susan Kim, +1

Eliza Schleifstein, +1 917-763-8106

Source: Akebia Therapeutics, Inc.

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