Akebia's Anemia Drug Disappoints In Mid-Stage COVID-19 Study

Akebia Therapeutics Inc 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.”
In April, FDA issued a partial clinical hold on the drug’s pediatric studies, triggering layoffs. Then in May, Otsuka Holdings OTSKY called off its licensing and co-development pact.
Earnings: The company reported Q2 Auryxia (ferric citrate) sales of $43.7 million, +32.4% Y/Y. Akebia increased 2022 net Auryxia product revenue guidance to $170 - $175 million.
Total revenues increased to $126.8 million compared to $52.9 million a year ago.
The company ended the quarter with $143.9 million.
Price Action: AKBA shares are down 2.39% at $0.40 during the market session on the last check Friday.