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Tonix Pharmaceuticals Announces Plan to Complete the Phase 3 RELIEF Study of TNX-102 SL for Management of Fibromyalgia with Currently Enrolled Participants Based on Results of Interim Analysis
Topline Results of Full Study Expected Fourth Quarter 2020 RELIEF Study Protocol Was Formally Amended Mid-Study to Conform to FDA Guidance During COVID-19
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Topline Results of Full Study Expected Fourth Quarter 2020\n RELIEF Study Protocol Was Formally Amended Mid-Study to Conform to FDA Guidance During COVID-19 Public Health Emergency Currently Enrolled 503 Participants Represents More than Original Target of 470 Company is Currently Enrolling a Second Potential Pivotal Phase 3 Study (RALLY) of TNX-102 SL in Fibromyalgia, with Topline Data Expected Second Half of 2021 CHATHAM, N.J., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today the outcome of the pre-planned interim analysis for the Phase 3 RELIEF study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. An independent statistical team conducted the unblinded interim analysis of the primary endpoint of the first 50 percent of randomized participants who entered the 14-week study. Based on the interim results and the prespecified sample size re-estimation, the independent data monitoring committee (IDMC) made the non-binding recommendation that the trial continue to completion with the addition of 210 participants to the original sample size of 470 participants, which is the maximum number of participants that could be added under the interim statistical analysis plan. Based on this information, the Company plans to complete the study with the 503 currently enrolled participants and to report topline results in the fourth quarter of 2020. The Company remains blinded to the interim analysis results. “We plan to complete the Phase 3 RELIEF study without adding new participants,” commented Seth Lederman, M.D., President and Chief Executive Officer. “We started enrolling RELIEF in December 2019 and continued to enroll and study fibromyalgia sufferers through the onset and progression of the COVID-19 pandemic. We made changes to the protocol to conform to the U.S. Food and Drug Administration’s (FDA’s) guidance on research during the COVID-19 public health emergency. We need to consider the possibility that the onset of the COVID-19 pandemic affected both the reporting and variability of fibromyalgia symptoms in the interim analysis cohort, or first half, of the RELIEF participants in a way that was not anticipated prior to the pandemic. It is also possible that the seco...