Benzinga | Sep 29, 2020 04:06PM EDT

Tonix Pharmaceuticals Announces Plan To Complete 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 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 second half of the RELIEF participants, enrolled after April 22, 2020, may have been affected by the ongoing nature of the pandemic, but differently than the first half which comprised the interim analysis cohort. The interim analysis plan did not contemplate any differences between the interim analysis cohort and subsequent cohort. The possibility that there are differences between the cohorts is the basis for our decision to complete the study without adding new participants, since the IDMC recommendation was based only on analysis of the interim analysis cohort. We believe that recruiting participants to the ongoing RALLY study is a more efficient use of resources than expanding the RELIEF study. Based on the prior Phase 2 and Phase 3 studies in fibromyalgia at a lower dose, we believe that TNX-102 SL has potential as a novel non-opioid, centrally-acting analgesic for the millions of U.S. adults suffering with fibromyalgia."

Dr. Lederman continued, "Fibromyalgia is a significant treatment market in which the annual sales of approved drugs grew to more than $9 billion before Cymbalta(r) and Lyrica(r) went off patent. The dollar value of the fibromyalgia drug market has since decreased because of generic substitution, but the number of sufferers has not. We believe many are dissatisfied with available drug treatments. Poor tolerability is often a reason why patients give up taking the currently approved drugs. As many as one-third of fibromyalgia patients end up on chronic opiates. TNX-102 SL has the potential to provide relief from the pain and dysfunction of fibromyalgia with good tolerability and without addictive potential. We look forward to assessing top-line data from RELIEF in the fourth quarter of 2020."

Tonix is currently enrolling into a second potentially pivotal Phase 3 trial, F306 or the RALLY study, to study TNX-102 SL for the management of fibromyalgia, with topline data expected in the second half of 2021. The trial design is very similar to the ongoing Phase 3 RELIEF study. The Company expects the FDA to require two positive registration-quality clinical studies to support marketing approval.