Tonix begins dosing in Phase II trial of TNX-102 SL to treat post-traumatic stress disorder

The randomized, double-blind, placebo-controlled Phase II trial was designed to evaluate the efficacy and safety of TNX-102 SL in people with military-related PTSD and related conditions.

Tonix president and chief executive officer Seth Lederman said: "This is an important event for Tonix and for the estimated eight million US adults suffering from PTSD, a serious illness with limited treatment options, since there has been no new treatment in PTSD in a decade.

"A growing body of evidence suggests a link between poor sleep quality and PTSD symptoms. We expect that TNX-102 SL can improve several sleep quality measurements with a safety profile similar to placebo, as previously demonstrated in our Phase IIb BESTFIT study in fibromyalgia."

Around 220 participants are expected to be enrolled in the three-arm trial and they will be randomized to receive two tablets of study medication to be taken sublingually at bedtime daily for 12 weeks.

In the two active arms, patients will be given either one 2.8mg TNX-102 SL tablet and one placebo tablet or 5.6mg of TNX-102 SL (2 x 2.8mg tablets).

The company said that in the placebo comparator arm, patient will be given two placebo tablets.

The trial’s primary endpoint is the week eight mean change from baseline in the total Clinician-Administered PTSD Scale (CAPS-5) score in participants who received 2.8mg of TNX-102 SL as compared to those who received placebo only.