Phase 3 Program to Begin in the Second Quarter of 2015
NEW YORK, Jan. 6, 2015 -- Tonix Pharmaceuticals Holding Corp. (TNXP) has received written guidance from the U.S. Food and Drug Administration (FDA) on its Phase 3 clinical study design for TNX-102 SL in fibromyalgia.
"Getting this confirmation from the FDA -- particularly its acceptance of the 30 percent responder analysis as the primary outcome measure -- represents a clear step forward in our ongoing development of TNX-102 SL in fibromyalgia," said Seth Lederman, M.D., president and chief executive officer of Tonix.
The 30 percent responder analysis is defined as an improvement in pain, as measured by the number of subjects who achieve at least a 30 percent improvement in their pain scores. In the Phase 2b BESTFIT study, TNX-102 SL demonstrated a statistically significant improvement in the 30 percent responder analysis, which was a pre-specified secondary outcome measure.
Dr. Lederman added, "Our proposed Phase 3 study design is based on our analysis and learnings from the BESTFIT trial results. We are on track to begin the Phase 3 clinical study in this debilitating condition in the second quarter of this year."
About Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a clinical-stage company developing first-in-class medicines for common disorders of the central nervous system, including fibromyalgia, post-traumatic stress disorder (PTSD), and episodic tension-type headache. These disorders are characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. Tonix's lead candidate, TNX-102 SL, is intended to be a first-line treatment for fibromyalgia and for PTSD. A Phase 2b trial of TNX-102 SL in fibromyalgia (BESTFIT) has been completed, and Tonix is preparing to initiate a Phase 3 program to support registration. A Phase 2 trial of TNX-102 SL in PTSD (AtEase) is recruiting. TNX-201 is in clinical development for episodic tension-type headache and recently completed a Phase 1 comparative pharmacokinetic and safety study. To learn more, please visit www.tonixpharma.com