Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) has unveiled positive results from a trial of a potential new drug to treat military related post-traumatic stress disorder (PTSD).
The company said it had successfully demonstrated a dose-response relationship on multiple efficacy and safety measurements.
On the Nasdaq, the stock jumped around 20% in premarket deals to change hands at US$2.90.
The Phase 2 trial, named the AtEase study, had 231 enrolled patients across 25 clinical sites in the United States. The placebo controlled trial saw the drug (called TNX-102 SL) given in two doses - 2.8 mg or 5.6 mg. It was given in a bedtime sublingual dose.
Tonix told investors that the 2.8 mg dose trended in the direction of a therapeutic effect, but did not reach statistical significance on the primary endpoint. The 5.6 mg dose, however, did show a statistically significant response.
It added that TNX-102 SL 2.8 mg and 5.6 mg were well tolerated as evidenced by the high overall completion rate in the active treatment groups.
DR Jonathan Davidson, professor of Psychiatry and Behavioral Sciences at Duke University Medical Center, in a statement said: “There is a continuing need to develop effective and well-tolerated treatments for people whose daily living is impaired by PTSD.
“I am encouraged by the results that have emerged from this well-designed and carefully executed study and look forward to seeing this drug treatment advance into a registration clinical program.”
Seth Lederman, Tonix chief executive, added: “TNX-102 SL 5.6 mg taken sublingually at bedtime demonstrated efficacy (reduction in CAPS-5 score) and safety for the treatment of military-related PTSD compared to placebo.”
“We are pleased to have established a dose-response relationship of TNX-102 SL in this Phase 2 PTSD study and identified the 5.6 mg dose as appropriate for Phase 3 development.
“We plan to meet with the FDA to discuss the clinical program to support the registration of TNX-102 SL 5.6 mg for the treatment of PTSD.”