Tonix Pharmaceuticals (NASDAQ:TNXP) is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for chronic migraine.
The modifications are designed to streamline the trials and to provide topline data for both programs in 2023.
Target enrollment for the core TNX-102 SL fibromyalgia study remains at about 470 participants while target enrollment for the TNX-1900 chronic migraine study will be reduced from approximately 300 participants to approximately 150 participants, to accommodate the new topline timing.
“By eliminating the interim analyses, we remove the statistical penalties associated with this type of analysis, conserve resources, and can plan on topline results for each of these studies in the fourth quarter of 2023,” Seth Lederman, M.D. and CEO of Tonix, said in a statement.
