Tonix Pharmaceuticals has reported that the Phase II PREVAIL study of TNX-102 5.6 mg sublingual (SL) tablet for the management of fibromyalgia-type long Covid failed to meet the pre-specified primary endpoint of improving long Covid pain intensity scores at week 14.

The proof-of-concept, multicentre, placebo-controlled, double-blind, randomised study assessed the safety and efficacy of the tablet in patients with laboratory-documented Covid-19 preceding long Covid.

It was carried out at nearly 30 sites in the US. A total of 63 patients were enrolled who received TNX-102 daily at bedtime.

TNX-102 SL showed a robust effect size of 0.5 in improving fatigue along with consistent activity across secondary measures of sleep quality, cognitive function, disability and Patient Global Impression of Change.

TNX-102 SL was generally well tolerated with no new safety signals.

Tonix Pharmaceuticals chief medical officer Gregory Sullivan said: “We believe the PREVAIL trial results will help guide the next phase of development for TNX-102 SL, supporting the design of a potential registrational trial for fibromyalgia-type long Covid based on PROMIS fatigue as a primary endpoint, pending review and feedback from the FDA.

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“In both of our prior Phase III studies of TNX-102 SL 5.6mg in fibromyalgia, we observed numerical improvement in the PROMIS fatigue score (in RELIEF p=0.007 MMRM and in RALLY p=0.007 MMRM).

“Although the validity of PROMIS Fatigue is not yet established in long Covid, we believe the results of PREVAIL, together with extensive data from studies in other chronic conditions – including Tonix’s studies in fibromyalgia – make PROMIS Fatigue a solid candidate for the primary endpoint of future long Covid registrational studies.”

The company is also planning to meet with the US Food and Drug Administration (FDA) in the first quarter of next year to discuss the potential Phase III programme of TNX-102.

TNX-102 SL is a multifunctional agent with potent binding and antagonist activities at the α1-adrenergic, H1-histaminergic, M1-muscarinic, and 5-HT2A-serotonergic receptors.