- Following an unblinded, pre-planned interim analysis by the Independent Data Monitoring Committee (IDMC), Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) will stop enrollment in the Phase 3 RALLY study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for fibromyalgia.
- The IDMC recommended stopping the trial for futility as TNX-102 SL is unlikely to demonstrate a statistically significant improvement in overall change from baseline in pain (primary endpoint) compared to placebo.
- Tonix remains blinded to the detailed interim analysis results and only received the recommendation.
- Preliminary blinded safety data did not reveal any new safety signals, and the decision to discontinue enrollment is not related to safety.
- The company intends to continue studying those enrolled participants until completion and then proceed with a full analysis of the unblinded data.
- Topline results are expected in Q4 of 2021.
- Price Action: TNXP shares are down 34.2% at $0.65 during the premarket session on the last check Monday.
- Related content: Benzinga’s Full FDA Calendar.
