Tonix Pharmaceuticals Study Results Miss Endpoint

Tonix Pharmaceuticals announced that topline results from its Phase 2 proof-of-concept study of TNX-102 SL 5.6 mg for the management of fibromyalgia-type Long Covid did not meet its primary endpoint. As a result, the company's shares fell 11% to 90 cents.

The stock has experienced a significant decline over the past year, reaching its 52-week low of $1.22 on Sept. 1 and decreasing by 93%.

Although TNX-102 SL showed potential improvement for 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 on fatigue and demonstrated consistent activity in secondary endpoints such as sleep quality, cognitive function, disability, and patient global impression of change.

TNX-102 SL aims to enhance sleep quality, an area targeted for future clinical trials in Long Covid according to the National Institutes of Health.

The overall tolerability of TNX-102 SL was comparable to previous studies, with similar rates of adverse event-related discontinuations between the drug and placebo groups. No new safety concerns emerged.

Tonix Pharmaceuticals plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration in the first quarter of 2024. This meeting will serve as an opportunity to discuss a potential Phase 3 program based on a proposed primary outcome measure using the PROMIS Fatigue scale.