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Tonix’s long COVID drug fails to meet mid-stage trial goal
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(Reuters) – Tonix Pharmaceuticals Holding Corp 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.
(Reuters) – Tonix Pharmaceuticals Holding Corp 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.
(Reporting by Leroy Leo in Bengaluru; Editing by Dhanya Ann Thoppil)
Long COVID refers to a range of symptoms that continue for weeks or months after the initial recovery from COVID-19, including fatigue, muscle pain, and cognitive difficulties.
A mid-stage trial, often referred to as Phase 2, tests the efficacy and safety of a drug on a larger group of participants after initial safety is established in Phase 1.
TNX-102 SL is an experimental drug developed by Tonix Pharmaceuticals aimed at treating conditions like long COVID, particularly focusing on symptoms like muscle pain and fatigue.
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