Tonix Pharmaceuticals presents additional efficacy data from RESILIENT

Tonix Pharmaceuticals announced the presentation of additional efficacy data from RESILIENT, the second positive Phase 3 study evaluating Tonmya for the management of fibromyalgia, at the 6th International Congress on Controversies in Fibromyalgia in Brussels, Belgium, March 7-8, 2024. In presenting more detailed data from the RESILIENT study, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, said, “We previously reported statistically significant and clinically meaningful results in all six key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function. We now report that the effect sizes of the five continuous key secondary outcomes measures ranged from 0.3 to 0.5. The results also showed that Tonmya treatment resulted in an improvement in cognitive dysfunction, or ‘brain fog’, measured by the change in the Fibromyalgia Impact Questionnaire-Revised memory item. The FIQ-R cognitive item showed nominal improvement in Tonmya-treated patients vs placebo-treated patients with a p=0.001 and effect size of 0.31. Together, we believe the activity of Tonmya on pain, sleep quality, fatigue and brain fog are indicative of broad-spectrum activity of Tonmya and suggest that Tonmya treats fibromyalgia at a syndromal level.” As previously announced, RESILIENT met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo in participants with fibromyalgia. RELIEF, the first Phase 3 trial of Tonmya 5.6 mg in fibromyalgia, was completed in December 2020. It also met its pre-specified primary endpoint of daily pain reduction compared to placebo. Tonix plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of 2024 and has scheduled a pre-NDA meeting with FDA in the second quarter of 2024. Tonmya was not associated with increases in systolic or diastolic blood pressure or body weight, nor were there any reported sexual side effects in the RESILIENT trial. In addition, when systematically investigated using the Changes in Sexual Functioning Questionnaire short form women who received study drug had a higher CSFQ-14 total score relative to those who received placebo, which is consistent with improved sexual function.