Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) has confirmed having received the minutes of a meeting it held with the U.S. Food and Drug Administration (FDA). The meeting christened Breakthrough Therapy Type B Clinical Guidance took place on October 29th October. It was addressing concerns of an impending Phase 3 trial of TNX-102 SL, which if approved will treat posttraumatic stress disorder (PTSD).
The trial will kick – off in the first quarter of 2019. It will include individuals who have had PTSD within the past nine years. Civilian and military PTSD patients will also be part of the study. The Phase 3 HONOR trial had omitted them having incorporated only those with military-related PTSD. However, the critical change will be that of baseline in CAPS-5 score at four weeks to baseline in CAPS-5 score at 12 weeks.
The new trial will be a random, double-blind, placebo-controlled study
The study anticipates having approximately 250 subjects. The number is much lower than the 550 subjects expected to enroll in the HONOR trial. In the latter later trial, subjects must have experienced trauma from 2001 or later. Meanwhile, the trial expected to take over 12weeks will be random, double-blind and placebo-controlled study.
The 12 weeks are supposed to present any form of changes in CAPS-5 score. The primary endpoint will be the Week 4 mean change. However, there is an expectancy of topline results before the closure of the first half of 2020.
In support of this expectancy, President and Chief Executive Officer of Tonix, Seth Lederman, said, “The minutes from our Breakthrough Therapy Clinical Guidance meeting with the FDA are consistent with our previous assessment. We are moving forward expeditiously…”
Improving biodefense through potential medical counter-measures
In the recent past, Tonix has been making headlines in its efforts to enhance biodefense through the use of potential medical counter-measures. The clinical-stage biopharmaceutical company is putting all its focus on the development of pharmaceutical products, which take care of serious neuropsychiatric conditions. It is currently developing many investigational new drugs such as TNX-801, TNX-601, and TNX-102 SL.