Tonix Completes Phase 1 Study Of TNX-201 In Episodic Tension-type Headache

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) Friday said it has completed a Phase 1 safety, tolerability, and pharmacokinetic study of TNX-201, being developed for episodic tension-type headache.

In this single ascending dose, placebo-controlled trial, TNX-201 was well-tolerated at all doses studied, and showed a dose-related increase in pharmacokinetic parameters.

A Phase 2, double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-201 for the treatment of a single episodic tension-type headache will commence in the second quarter of 2015.

The Phase 1 study was in 45 subjects divided into three cohorts receiving 35 mg, 70 mg and 140 mg TNX-201 capsules. Each cohort consisted of 15 subjects, who were randomly assigned in a 3:1:1 ratio to TNX-201, racemic isometheptene mucate (70 mg), or placebo, respectively.

All treatments were well tolerated and no subject discontinued due to treatment-emergent adverse events.

Four adverse events that were deemed to be possibly related to treatment were mild forehead erythema and pruritis, mild sensation of warmth, and mild temporal headache. No adverse event was reported in the highest dose TNX-201 (140 mg) group.