Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced that it will halt its Phase 3 HONOR study of its Tonmya drug, sending the stock plummeting.
The pharmaceutical company said that trials for Tonmya, a treatment for military-related post-traumatic stress disorder, or PTSD, resulted in "inadequate separation from placebo" on the primary endpoint at week 12, though better results occurred at week four.
The trial results sent shares tumbling by 67.7% to US$1.26 in midday trading.
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Despite this setback, Tonix CEO Seth Lederman said that he was still encouraged by the meaningful clinical improvement at week 4, which replicates findings in the previously reported Phase 2 AtEase Study. He now wants to meet with the US Food and Drug Administration to discuss the results from HONOR, which he indicated on a statement would help to design the next pivotal study.
The HONOR study was carried out as a randomized, placebo-controlled study of up to 550 participants with PTSD at 40 US clinical sites.
The Independent Data Monitoring Committee (IDMC) reviewed the results of the first 50% of participants in the HONOR study and recommended stopping the trial based on results at week 12.
The New York-based company specializes in producing drugs to treat central nervous system conditions.
In addition to Tonmya, Tonix is developing TNX-102 SL, which has been granted Fast Track designation by the FDA, as a bedtime treatment for agitation in Alzheimer’s disease under an IND to support a Phase 2, potential pivotal, efficacy study.
--Written by Belinda Robinson for Proactive Investors