Tonix Pharma AFFIRM trial fails

Tonix Pharmaceuticals Holding (NASDAQ:TNXP) said its Phase 3 AFFIRM study, designed to evaluate the safety and efficacy of TNX-102 SL in patients with fibromyalgia, did not achieve statistical significance in the primary efficacy endpoint.

Fibromyalgia is a multi-symptom disorder that originates in the central nervous system and is characterized by widespread pain, non-restorative sleep, fatigue, and disability.

The company said it would stop testing its experimental drug for fibromyalgia and would focus its resources on advancing TNX-102 SL for post-traumatic stress disorder (PTSD). 

In a statement, Dr. Seth Lederman, president and CEO, said TNX-102 SL showed broad beneficial effects across key fibromyalgia symptoms and was well tolerated in the AFFIRM study.

“Despite achieving clinically meaningful results from AFFIRM, we have greater clarity on the regulatory path forward in our PTSD program,” he added. “We will therefore discontinue the fibromyalgia program in order to fully focus Tonix’s resources on advancing our potential breakthrough PTSD program to Phase 3.”