Tonix Pharmaceuticals (US:TNXP)2021-05-21 19:37TNX-102 SL for Fibromyalgia (FM) - TNX-102 SL achieved statistical significance in reducing daily pain (p=001) in the Phase 3 RELIEF study with 503 participants[26, 31] - In the RELIEF study, 468% of participants on TNX-102 SL achieved a 30% or greater reduction in pain, compared to 349% on placebo (p=006)[32] - The F304/RELIEF study showed that TNX-102 SL had nominally significant improvements in FIQ-R Symptom Domain (p=007), FIQ-R Function Domain (p=009), PROMIS Fatigue (p=018), Daily Sleep Quality (p<001), and PROMIS Sleep Disturbance (p<001)[38] - A second Phase 3 study, F306/RALLY, is ongoing with approximately 670 participants, with topline results expected in the first quarter of 2022[49, 51] COVID-19 Vaccine Candidates - TNX-1800, a COVID-19 vaccine candidate, demonstrated positive immune response in non-human primates, with undetectable SARS-CoV-2 by PCR in upper and lower airways after challenge[65] - TNX-1800 vaccination of non-human primates elicited anti-SARS-CoV-2 neutralizing antibodies (≥1:40 titer) in all eight animals at Day 14 after a single vaccination[87] - TNX-3500 (sangivamycin) is 65 times more potent than remdesivir in inhibiting SARS-CoV-2 in cell culture infectivity studies[129] - TNX-2300 is a second SARS-CoV-2 vaccine platform utilizing Bovine Parainfluenza (BPI) Virus[132] - TNX-2100 is a potential skin test to measure SARS-CoV-2 exposure and T cell immunity[138] Other Pipeline Programs - TNX-1300 (cocaine esterase) rapidly reversed the physiologic effects of cocaine, with cocaine plasma exposures dropping by 90% within two minutes in a Phase 2 study[146] - TNX-1900 (intranasal oxytocin) is being developed as a prophylactic treatment for chronic migraine, with a Phase 2 study expected to start in the third quarter of 2021[160, 172] - TNX-601 CR (tianeptine oxalate and naloxone HCl) is a controlled-release tablet for major depressive disorder (MDD), with a Phase 2 study expected to start in the fourth quarter of 2021[181, 184]