Akebia Therapeutics Inc. (NASDAQ:AKBA) has announced the publication of details of its study design and methodology of the global third phase INNO2VATE program in the Nephrology Dialysis Transplantation (NDT) Journal. The publication of the company’s manuscript of the INNO2VATE program in the journal is the first peer-reviewed publication related to the program of Oral hypoxia-inducible factor propyl hydroxylase inhibitor (HIF-PHI). The company is evaluating HIF-PHI as a possible treatment for chronic kidney disease anemia.
The publication shows the demographic characteristics of patients
The published manuscript is titled “Global Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney diseases: rationale, study design and baseline characteristics of dialysis-dependent patients in the INNO2VATE trials.” The publication also includes a detailed description of the methodology and design of the two-phase 3 INNO2VATE studies and summarised demographic and baseline features of randomized patients. Most importantly, the manuscript shows that “demographics and baseline characteristics of patients enrolled in the two studies are comparable to those observed in patients with dialysis dependent-CKD.” This suggests that the INNO2VATE trials will be trials’ results to a large percentage of the dialysis-dependent-CKD population.
The INNO2VATE study evaluated the safety and efficacy of vadadustat the, company’s investigational oral HIF-PHI against darbepoetin alfa in the treatment of anemia of CKD in patients on dialysis. Akebia previously reported that vadadustat achieved primary and secondary efficacy endpoints and primary safety endpoint in the INNO2VATE program. The primary safety endpoint was defined as the non-inferiority of vadadustat against darbepoetin alfa during the first MACE (Major Adverse Cardiovascular Event) occurrence.
INNO2VATE study produced consistent results
Steven Burke, the company’s Chief Medical Officer, and SVP Research and Development said that the publication of the design of the global phase 3 INNO2VATE program in the journal is a massive achievement. He said that they believe that this publication will reinforce clinical thoroughness that aided the INNO2VATE study that produced the program’s development and clear results. Burke said that the company’s medical team would continue supporting vadadustat’s potential with an exceptional publication plan to yield more peer-reviewed material.
