Tonix Pharmaceuticals has enrolled the first subject in the Phase II PREVAIL clinical trial of TNX-102 SL to potentially treat a subset of long Covid syndrome patients with symptoms that overlap with fibromyalgia.
The multicentre, double-blind, randomised, placebo-controlled trial will analyse the safety and efficacy of a daily dose of TNX-102 SL at bedtime in long Covid patients with pain at multiple sites.
It will be carried out at nearly 30 US sites and is expected to enrol nearly 470 patients.
These subjects will be categorised into a 1:1 ratio to receive TNX-102 SL or placebo tablets.
The variation from baseline in the weekly average of worst pain intensity scores self-reported by subjects daily at 14 weeks is the primary efficacy endpoint of the trial.
Variation in self-reported scores for sleep disturbance, cognitive function, and fatigue from baseline will comprise the trial’s key secondary efficacy endpoints
To potentially re-estimate the sample size or to halt the trial early for efficacy, the company plans to carry out an interim assessment in the first half of next year, after the first half of the subjects conclude the study.
Tonix Pharmaceuticals CEO Seth Lederman said: “Findings from our retrospective observational database study in over 50,000 long Covid patients showed that more than 40% of long Covid patients in the sample have fibromyalgia-like, multi-site pain symptoms, suggesting that we should be able to recruit a robust cohort of participants to test the effects of TNX-102 SL in treating this condition.
“Our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with long Covid whose symptoms overlap with fibromyalgia.”
In April this year, the company obtained clearance from the US Food and Drug Administration for an Investigational New Drug application to commence the Phase II trial of TNX-102 SL for long Covid.