Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) has announced results of the pre-planned provisional analysis of the third phase RELIEF trial of cyclobenzaprine HCI sublingual tablets (TNX-102 SL) 5.6mg in managing fibromyalgia.
The Independent data monitoring committee recommended expansion of the study
An independent analysis team conducted the primary endpoint’s provisional analysis of the first 50% of randomized subjects that had entered the 14-week trial. Going by the provisional results and the pre-specified re-estimation of sample size, the independent data monitoring committee made non-binding recommendations that the study should go on to completion with 210 more participants included in the original sample of 470 participants. This is the maximum number of new participants included as per the preliminary statistical analysis design. As per this information, Tonix is planning to complete the trial with 503 participants currently enrolled in the study and report topline data in Q4 2020.
Seth Lederman, the CEO and President of the company indicated that they are planning to complete the third phase RELIEF trial without more participants. Enrolment in the study commenced in December 2019, and despite the COVID-19 pandemic Tonix has continued enrolment and studying of fibromyalgia patients. Lederman indicated that the company made protocol changes in conformation to the FDA’s guidance on research during the pandemic. The pandemic affected the reporting as well as the variability of fibromyalgia symptoms in the provisional analysis group of the RELIEF subjects in unforeseen ways.
Pandemic impacted on the RELIEF Study results
Also, the second batch of the RELIEF-study patients enrolled on April 22, 2020, could have been affected by the pandemic but in different ways compared to the first half that made up the interim analysis group. The CEO said that because of the possibility of differences between the groups, they chose to complete the study without adding new participants since the recommendations of IDMC were based in the interim analysis cohort. Most importantly, Tonix is optimistic that TNX-102 SL can potentially be a proprietary non-opioid centrally acting analgesic for fibromyalgia patients.