Safety Concern Offsets Chronic Kidney Disease Study Positive Results

Health and Healthcare

Published: September 3, 2020 12:22 pm

On Thursday, Akebia Therapeutics Inc. (NASDAQ: AKBA) announced topline results from the Phase 3 PRO2TECT studies evaluating the safety and efficacy of vadadustat in chronic kidney disease (CKD). Shares were crushed afterward.

This is Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which is seeking to treat anemia due to CKD in adult patients not on dialysis. Akebia’s vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the company reported positive topline data in May.

Management noted that it believes the cardiovascular safety of vadadustat is supported by the totality of the data from the global Phase 3 program, including additional analyses on cardiovascular outcomes observed within key geographic regions and across certain patient sub-populations within the PRO2TECT study.

Vadadustat achieved each of the PRO2TECT studies’ primary efficacy endpoints as well as the key secondary efficacy endpoint. However, what ultimately crushed the stock was the fact that the study failed to meet the safety goal.

Again, management noted that while achieving the safety endpoint would have made the path more straightforward, as it is in dialysis, the firm still believes it has a path toward approval.

Looking ahead, Akebia is working to present the full dataset from its global Phase 3 program (INNO2VATE and PRO2TECT) at an upcoming medical conference and publish the data in peer-reviewed journals.

Also, Akebia plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat for the treatment of anemia due to CKD in adult dialysis-dependent and non-dialysis dependent patients as early as possible in 2021.

Akebia stock traded down about 72% on Thursday to $2.77, in a 52-week range of $2.75 to $13.71. The consensus price target is $17.14.

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