Tonix Pharmaceuticals Holding Corp. (TNXP) said that it has decided to stop enrollment in the Phase 3 RALLY study of TNX-102 SL --cyclobenzaprine HCl sublingual tablets-- 5.6 mg for the management of fibromyalgia.
The company said its decision follows a recommendation from an interim analysis indicating inadequate separation from placebo at week-14 in the first 50% of participants.
TNXP closed Friday regular trading at $0.98, down $0.03 or 2.97%. In the after-hours trade, the stock further dropped $0.33 or 33.78%.
The Independent Data Monitoring Committee (IDMC) recommended stopping the trial for futility as TNX-102 SL is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in daily diary pain severity scores between those treated with TNX-102 SL 5.6 mg (2x 2.8 mg tablets) and those receiving placebo.
Tonix said it remains blinded to the detailed interim analysis results and only received the recommendation made by the IDMC. Preliminary blinded safety data from these participants did not reveal any new safety signals, and the decision to discontinue enrolling new participants is not related to safety.
The company plans to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data, with the topline results expected to be reported in the fourth quarter of 2021, to determine the next steps in this program.
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