Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has announced that, as anticipated based on prior reported pre-specified preliminary analysis findings, TNX-102 SL failed to attain statistical significance on its primary endpoint of fibromyalgia pain reduction at Week 14 relative to placebo in the third phase RALLY study.
RALLY study halted in July 2021
RALLY was a 14-week, double-blind, randomized, placebo-controlled study that evaluated TNX-102 SL 5.6 mg, whereby 514 FM subjects were randomized 1:1 in 36 study sites in the US. All participants were given TNX-102 SL 2.8 mg or placebo for 14 days before the doses were increased to two tablets (5.6 mg) or two placebo tablets for the rest of the 12 weeks.
The company released interim findings of RALLY in July 2021, during which the interim Independent Data Monitoring Committee recommended a halt of the study since it was unlikely to succeed on the primary endpoint for the scheduled full sample. As a result, Tonix stopped the recruitment of new participants but continued the study with those already enrolled to completion.
Already TNX-102 SL is in the middle of the third phase of development for fibromyalgia development. In addition, the company released positive findings in December 2020 from the third Phase Relief study for TNX 102 WL 5.6 mg for FM management.
RELIEF study also reported 775 increase in adverse events
Chief Medical Officer Gregory Sullivan stated, “The positive outcome of the earlier RELIEF study stands in contrast to the missed primary endpoint in RALLY. We believe the difference between these study results may be driven in large part by a 79% increase in adverse event-related participant discontinuations in the drug treatment group in RALLY as compared to RELIEF. Similarly, a 77% increase of adverse event-related participant discontinuations was observed in the placebo group in RALLY as compared to RELIEF.”
CEO Seth Lederman said, “Without knowing the precise reasons, we postulate the increased rate of adverse event-related discontinuations may be related to conducting the study during the peak phase of the COVID-19 pandemic in the U.S., during which time vaccines were being rolled out.”
