Tonix Pharma Reports Topline Results From Phase 2 PREVAIL Proof-of-Concept Study Of TNX-102 SL

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) announced topline results from the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL 5.6 mg for the management of fibromyalgia-type Long COVID. 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, the company said. TNX-102 SL treatment showed a robust effect size in improving fatigue. It also showed consistent activity trending to improvements across the secondary endpoints of sleep quality, cognitive function, disability and patient global impression of change.

The company plans to request an End-of-Phase 2 meeting with the FDA to discuss a potential Phase 3 program based on a proposed primary outcome measure using the PROMIS Fatigue scale. The meeting is anticipated to take place in the first quarter of 2024.

Gregory Sullivan, Chief Medical Officer of Tonix Pharmaceuticals, said: "Although the validity of PROMIS Fatigue is not yet established in Long COVID, we believe the results of PREVAIL, together with extensive data from studies in other chronic conditions3-5 - including Tonix's studies in fibromyalgia - make PROMIS Fatigue a solid candidate for the primary endpoint of future Long COVID registrational studies."

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