Tonix Pharma Reports Top Line Results From Phase 2b BESTFIT Trial Of TNX-102 SL

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) announced top line results of the Phase 2b BESTFIT (BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy) study of TNX-102 SL as a chronic bedtime treatment for fibromyalgia. The study did not achieve statistical significance in the primary efficacy endpoint of change in average daily pain score at week 12. The company noted that TNX-102 SL showed broad activity across key fibromyalgia symptoms in the BESTFIT study, and the treatment was well tolerated. The results also supported the potential clinical benefit of TNX-102 SL for the treatment of post-traumatic stress disorder, the company said.

Seth Lederman, CEO of Tonix, said, "While the study did not achieve statistical significance on the primary endpoint, this is a very supportive study for the Phase 3 clinical program. Also, these findings validate our approach to develop a differentiated drug that acts beyond analgesia to improve multiple symptom domains of a complex condition. We plan to meet with the Food and Drug Administration to review the BESTFIT data and to design an acceptable Phase 3 program."

The company said the study did demonstrate that TNX-102 SL had a statistically significant effect on pain by a 30 percent responder analysis of the primary pain data. BESTFIT also showed statistically significant improvements with TNX-102 SL in the key secondary analyses of the Patient Global Impression of Change and the Fibromyalgia Impact Questionnaire-Revised total score. The study also showed statistically significant improvement with TNX-102 SL on measures of sleep quality, including the PROMIS Sleep Disturbance instrument.