Tonix Pharmaceuticals Shares Plummet 50% On Phase 3 Trial Failure

On Tuesday, Tonix Pharmaceuticals Holding Corp. (TNXP) announced that it had failed its phase 3 trial in patients with Fibromyalgia. The phase 3 trial, known as the "AFFIRM" trial, failed to meet on the primary endpoint of the study. The trial was designed in such a way to test efficacy and safety of Tonix's drug TNX-102 SL, which was given to patients in the study. 

The trial recruited a total of 519 patients across 35 centers in the United States. These patients were either given TNX-102 SL or a placebo compound. The length of the study was to assess a 12-week treatment period in which patients would be evaluated for their Fibromyalgia. For the patients that reported a 30% or greater reduction in pain the drug failed to reach statistical significance against the placebo. 

The only good news to come out of the study was that patients taking the TNX-102 SL drug did see improvements when analyzed with other pain scales. The problem is that at this time Tonix reaffirmed that it will discontinue the phase 3 Fibromyalgia program, and instead focus all efforts on its phase 3 PTSD drug. Investors should note that results for this trial could take 2 to 3 years.

Therefore, it is prudent to consider holding long for those expecting to buy Tonix shares for this phase 3 trial. Even then, it's a long shot at best because it is the last program in the company's pipeline. That's a big gamble, because if this last trial fails the company will have nothing of value left. Fibromyalgia is a disease characterized by a change in the nervous system where pain, fatigue, and disability can occur. 

Disclosure: None

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