Tonix Pharmaceuticals announced the topline results from its Phase 2 proof-of-concept study involving TNX-102 SL 5.6 mg for the management of fibromyalgia-type Long Covid. Unfortunately, the study was unable to meet its primary endpoint.

Although TNX-102 SL showed potential for improving Long Covid, it did not achieve the predetermined primary endpoint of reducing pain intensity scores at week 14.

However, the treatment did display positive effects in reducing fatigue and demonstrated consistent activity in improving secondary endpoints such as sleep quality, cognitive function, disability, and patient global impression of change.

TNX-102 SL works by targeting sleep quality, which has been identified as a focus area for future clinical trials on Long Covid by the National Institutes of Health (NIH).

Overall, TNX-102 SL was well tolerated by participants and had a comparable adverse event profile to prior studies. Both drug and placebo arms reported similar rates of discontinuation due to adverse effects, and no new safety concerns were identified.

In light of these findings, Tonix Pharmaceuticals plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the possibility of initiating a Phase 3 program. The proposed primary outcome measure for the program will incorporate the PROMIS Fatigue scale. The meeting is anticipated to take place in the first quarter of 2024.

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