Akebia's Anemia Drug Disappoints In Mid-Stage COVID-19 Study
Author: Vandana Singh | August 05, 2022 11:12am
Akebia Therapeutics Inc (NASDAQ:AKBA) announced initial findings from an investigator-sponsored study evaluating vadadustat for Acute Respiratory Distress Syndrome (ARDS) with COVID-19 and hypoxemia.
Akebia said the drug failed the primary endpoint, as measured by the National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS).
While the primary superiority threshold over placebo was 95%, researchers calculated a 94% probability that their drug was better than the placebo.
The University of Texas Health Science Center conducted the trial and was partially funded by Akebia. It enrolled 449 patients.
“While the trial missed its prespecified primary endpoint at Day14, we are extremely encouraged by the data and believe they support further developing vadadustat as a treatment for ARDS due to COVID-19 or other causes,” CEO John Butler said in a statement. “We will now work to review the full data set more thoroughly, consult with experts in the field and ultimately consult FDA on a potential path forward.”