Aerpio Pharmaceuticals Inc. said its medicine AKB-9778 did not improve the symptoms of diabetes-related vision loss, failing to meet the main goal of a mid-stage study.
The Cincinnati, Ohio-based biopharmaceutical company's stock was down by 69.41% following the news to $1.30 as of 9:33 a.m. ET on March 18, 2019.
Aerpio evaluated AKB-9778 against placebo in 167 patients with moderate to severe nonproliferative diabetic retinopathy in a phase 2b trial dubbed Time-2b.
Diabetic retinopathy is a disease of the eyes that can lead to mild vision problems and blindness.
The trial's main goal was to see an improvement of two or more steps in the severity of the disease on a scoring system.
After 48 weeks of treatment, about 9.6% of the total patients receiving the drug twice a day showed an improvement in the severity of their disease. About 3.8% of the total patients on placebo showed a similar improvement in their disease.
The results were not sufficient for the medicine to clear the trial. Meanwhile, the rate of progression to vision-threatening complications was similar in patients receiving the medicine and those on placebo.
The trial, however, showed encouraging data related to the secondary goals of changes in kidney function and in fluid pressure inside the eye, the company said in its March 18 press release. These results were similar to what was seen in a prior phase 2a trial called Time-2.
Aerpio said AKB-9778 was safe and well-tolerated throughout the trial.
The company noted that it will provide an update on the status of the program after a complete analysis of the data.
Aerpio CEO Stephen Hoffman that the data supports a potential role of the medicine in treating diabetic complications, including open angle glaucoma — a condition characterized by increased pressure in the eye that can damage the optic nerve leading to blindness.