Hope On The Horizon: Tonix Pharmaceuticals (NASDAQ:TNXP) Could Be On the Cusp of Changing Fibromyalgia Treatment Options With TNX-102 SL - Seite 2

The company recently announced the completion of the clinical phase of the RESILIENT study for the drug. This phase 3 registration-quality, double-blind, placebo-controlled study evaluated the efficacy and safety of TNX-102 SL at a dose of 5.6 mg for the management of fibromyalgia. The study included 457 patients enrolled across multiple sites in the United States. The company is anticipating topline results by the end of December 2023, which, if successful, is expected to be the final trial required for the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).

This would be the second positive phase 3 trial for the company following the positive results from the first phase 3 RELIEF trial in December 2020, focusing on the management of fibromyalgia. In the RELIEF study, TNX-102 SL at a dose of 5.6 mg and as compared to placebo revealed a statistically significant reduction in daily pain (p=0.01) in participants with fibromyalgia. A higher rate of responders to TNX-102 SL (47%) was observed than to placebo (35%; p=0.006) when the analysis was performed as a ≥30% pain responder analysis. TNX-102 SL at 5.6 mg showed activity in key secondary endpoints, which included improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific global symptomatic and functional recovery. The drug candidate was found to be well-tolerated among patients with fibromyalgia, having a safety profile comparable to TNX-102 SL in previous fibromyalgia trials. The most commonly reported treatment-emergent adverse effects could be described as tongue numbness (officially called oral hypoesthesia), oral paresthesia and product taste abnormality.

TNX-102 SL's application in the treatment of PTSD-related syndromes is also gaining traction. The company reports that the U.S. Department of Defense (DoD) is supporting the upcoming phase 2 study of TNX-102 SL in acute stress disorder, which is a precursor to PTSD. The trial will be conducted and sponsored by the University of North Carolina. A $3 million grant is expected to support a trial that will enroll approximately 180 patients at U.S. study sites who experience trauma from motor vehicle accidents. Enrollment is expected to initiate at the beginning of 2024. In light of these developments and the potential success of the company's other drugs in the pipeline, Tonix has several programs demonstrating considerable promise.