Tonix Pharmaceuticals (US:TNXP)2020-02-11 17:15TNX-102 SL for Fibromyalgia - TNX-102 SL is in Phase 3 clinical development for Fibromyalgia, a chronic pain condition [6] - Interim analysis results for the Phase 3 RELIEF study are expected in the 3rd Quarter of 2020, with topline data expected in the 1st Half of 2021 [6] - A retrospective analysis of the AFFIRM study showed statistically significant improvement in mean pain using both MMRM (p < 0001) and MMRM with MI (p < 001) [36] - The new Phase 3 RELIEF study is enrolling with approximately 470 participants across 40 US sites [38] Pipeline Expansion - Tonix is exploring TNX-102 SL for Agitation in Alzheimer's Disease (AAD), with a proposed Phase 2 study that could potentially support NDA approval [47, 48] - TNX-102 SL is also being considered for Alcohol Use Disorder (AUD), with plans to submit an IND application in 1Q 2020 for a Phase 2 Proof of Concept Study [50, 51] - TNX-601 CR (Tianeptine Oxalate Controlled Release) is a potential daytime treatment for depression and PTSD, with plans to initiate a Phase 2 study in depression, ex-US, in the second half of 2020 [65, 70, 84] Other Programs - TNX-1300 (cocaine esterase) is in Phase 2 development for cocaine intoxication and has received FDA Breakthrough Therapy designation [7, 81] A Phase 2 study showed that TNX-1300 rapidly reversed the physiologic effects of cocaine, with cocaine plasma exposures dropping by 90% within two minutes [54] - TNX-801 (live horsepox virus) is a potential smallpox and monkeypox preventing vaccine in the pre-clinical stage [74, 82] - An estimated 6-12 million adults in the US have fibromyalgia [17]