Tonix Pharmaceuticals Holding’s (NASDAQ:TNXP) TNX-102 SL did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at week 14 in the Phase 2 PREVAIL study.
However, TNX-102 showed a robust effect size in improving fatigue and showed consistent activity trending to improvements across the secondary endpoints of sleep quality, cognitive function, disability and patient global impression of change (PGIC).
“The robust activity of TNX-102 SL on the PROMIS Fatigue scale … is important because patients and experts view fatigue as the signature symptom of Long COVID and it has been identified as the dominant symptom contributing to disability,” Dr. Seth Lederman, president and CEO of Tonix, said in a statement.
“These findings fulfill the objectives of this proof-of-concept study in supporting the decision to advance the program based on a proposed primary endpoint using the PROMIS Fatigue scale,” he added.
The company intends 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 expected to take place in the first quarter of 2024.
“The data from PREVAIL reinforce our belief in TNX-102 SL as a potential bedtime medicine for the management of fibromyalgia-type Long COVID,” said Gregory Sullivan, M.D. and CMO of Tonix.
“We believe the PREVAIL trial results will help guide the next phase of development for TNX-102 SL, supporting the design of a potential registrational trial for fibromyalgia-type Long COVID based on PROMIS fatigue as a primary endpoint, pending review and feedback from the FDA,” he added.