(Reuters) - Akebia Therapeutics Inc said on Thursday its experimental drug failed to meet the main safety goal in a late-stage trial testing the treatment in patients with anemia due to chronic kidney disease and not undergoing dialysis.
The company’s shares fell as much as 73% to hit a record low of $2.67.
The safety concern is a blow to the company after Akebia reported positive trial data in May for the drug in patients with chronic kidney disease on dialysis, and could be a boost to Fibrogen Inc, which is developing a similar treatment.
Fibrogen could have the whole non-dialysis dependent market worth more than $2 billion to itself, Jefferies analyst Michael Yee said. The U.S. Food and Drug Administration is due to decide on Fibrogen’s drug by Dec. 20.
Akebia still plans to submit a marketing application to the FDA as early as possible in 2021 for adults who are dialysis-dependent, as well as for non-dialysis dependent patients.
The late-stage large study evaluated the efficacy and safety of Akebia’s treatment, vadadustat, versus Amgen Inc’s drug darbepoetin alfa.
The study found vadadustat failed to meet the safety goal, defined as non-inferiority to darbepoetin alfa, when compared with time to first occurrence of major adverse cardiovascular events. The drug, however, achieved the main goal and secondary goal on efficacy.
“We see these results adding regulatory uncertainty to both the dialysis-dependent and independent chronic kidney disease markets,” said RBC Capital Markets analyst Kennen MacKay, adding that the company may need to do further clinical study.
Anemia is a condition in which a person does not have enough healthy red blood cells to carry adequate oxygen to the body’s tissues and affects about 3 million Americans, according to American Society of Hematology.
Reporting by Dania Nadeem in Bengaluru; Editing by Shounak Dasgupta
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