Tonix Pharmaceuticals Holding Corp (TNXP.O) said on Tuesday its experimental drug failed to meet the primary goal in a mid-stage study for management of widespread muscle pain and tenderness associated with long COVID-19.
Shares of the company were down 12% in premarket trading.
The 63-patient study was designed to monitor the intensity of pain in patients who had long COVID and administered either the drug, TNX-102 SL, or placebo, but the trial failed to show improvement at week 14 of treatment, the company said.
However, the study showed that the drug helped reduce fatigue and improve sleep quality and cognitive function in the patients, the company said.
Tonix intends to meet officials from the U.S. Food and Drug Administration in early 2024 to seek permission to conduct a late-stage trial that focuses on reducing fatigue in patients with long COVID, an illness with no approved drugs.