Tonix Pharmaceuticals expedites fibromyalgia, chronic migraine programs

Tonix Pharmaceuticals announced that it is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for chronic migraine. The modifications to the RESILIENT and PREVENTION studies are designed to streamline the trials and to provide topline data for both programs in 2023. Target enrollment for the core TNX-102 SL fibromyalgia study remains approximately 470 participants while target enrollment for the TNX-1900 chronic migraine study will be reduced from approximately 300 participants to approximately 150 participants, to accommodate the new topline timing. Key Anticipated 2023 Milestones: Updated Guidance: Eliminating interim analysis of Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia. Eliminating interim analysis of Phase 2 PREVENTION study of TNX-1900 for chronic migraine; topline results now expected in the fourth quarter of 2023. Unchanged Guidance: Topline results of Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia in the fourth quarter of 2023. Topline results of Phase 2 PREVAIL study of TNX-102 SL for fibromyalgia-type Long COVID in the third quarter of 2023. Interim analysis results of Phase 2 UPLIFT study of TNX-601 ER for major depressive disorder in the fourth quarter of 2023. Initiate enrollment in a potentially pivotal Phase 2 study of TNX-1300 for the treatment of cocaine intoxication in the second quarter of 2023. Initiate enrollment in a Phase 1 study of TNX-1500 for the prophylaxis of rejection in kidney transplantation in the second quarter of 2023. Initiate enrollment in a Phase 1 study of TNX-801, a potential vaccine to protect against smallpox and mpox, in the second half of 2023. Continue development of TNX-2900, a small peptide for the treatment of hyperphagia in Prader-Willi syndrome, for which the FDA has granted Orphan Drug designation.