Tonix Pharmaceuticals (US:TNXP)2022-08-14 17:57Pipeline Highlights - TNX-102 SL is in development for Fibromyalgia (FM), Posttraumatic Stress Disorder (PTSD), and Long COVID (PASC), with Phase 2 studies for PTSD and Long COVID targeted to start in Q3 2022[11] - TNX-1300 for Cocaine Intoxication has FDA Breakthrough Designation and is in Mid-Phase 2, with a new Phase 2 study planned for Q4 2022[11, 55] - TNX-1900 for Migraine, Craniofacial Pain, and Binge Eating Disorder has a Phase 2 start targeted for 1H 2023[11] - TNX-601 ER for Depression, PTSD, and Neurocognitive Dysfunction from Steroids has a Phase 2 start targeted for 1Q 2023[11] - TNX-801 for Smallpox and monkeypox vaccine and TNX-1850 for COVID-19 Vaccine are both targeted to start Phase 1 trials in 1H 2023 and 2H 2023 respectively[16] TNX-102 SL for Fibromyalgia - A Phase 3 study, RESILIENT (F307), comparing TNX-102 SL 56 mg and placebo, enrolled its first patient in April 2022, with interim analysis results expected in 1Q 2023[26] - A previous Phase 3 study, RALLY (F306), missed its primary endpoint due to an unexpected ~80% increase in adverse event-related discontinuations in both drug and placebo arms[26] TNX-102 SL for Long COVID (PASC) - Long COVID can occur in approximately 30% of recovered COVID-19 patients[30] - The National Institutes of Health was awarded $115 billion to study Long COVID[30] - A Phase 2 study for treating a subset of Long COVID patients whose symptoms overlap with fibromyalgia is planned to start in Q3 2022[31] Opioid Use in Long COVID Patients - Data indicates that 501% to 511% of patients with Long COVID symptoms are taking opioids[45]