Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) shares are trading lower after the company announced topline results from the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL 5.6 mg for managing fibromyalgia-type Long COVID.
TNX-102 SL treatment showed a robust effect size (ES) in improving fatigue. It showed consistent activity trending to improvements across the secondary endpoints of sleep quality, cognitive function, disability, and patient global impression of change.
TNX-102 SL trended towards improvement but did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at Week 14.
TNX-102 SL demonstrated a favorable safety and tolerability profile over 14 weeks of treatment with no new safety signals.
Tonix plans to meet with the FDA to discuss a path to registration; fatigue is the signature symptom of Long COVID and the principal symptom overlapping with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and fibromyalgia syndromes.
Price Action: TNXP shares are down 9.01% at $0.91 on the last check Tuesday.
