Shares in Tonix Pharmaceuticals (NASDAQ:TNXP) nearly doubled Thursday after the Food and Drug Administration indicated it was "on board" with the design of a new Phase 3 clinical trial, RECOVERY, evaluating Tonmya for the treatment of posttraumatic stress disorder (PTSD).
The clinical-stage biotech said it planned to start the RECOVERY trial for the treatment of PTSD in the first quarter of 2019.
Investors sent shares of the company up 85% to $7.03 in morning trading.
New design features for the Tonmya (cyclobenzaprine HCl sublingual tablets) study include restricting participants to those with PTSD who experienced an index trauma within nine years of screening and including patients who have experienced civilian traumas in addition to military traumas.
The new trial will incorporate several new design features including restricting enrollment of study participants to individuals with PTSD who experienced an index trauma within nine years of screening, instead of 2001 or later as in the earlier Phase 3 HONOR study.
READ: Tonix Pharmaceuticals shares jump on favorable data related to PTSD drug
The RECOVERY study will also include participants who have experienced civilian traumas in addition to those with military-related traumas.
The primary endpoint will be the mean change from baseline in the severity of PTSD symptoms as measured by a scale called CAPS-5.
“The minutes from our breakthrough therapy clinical guidance meeting with the FDA are consistent with our previous assessment,” said Tonix Pharmaceuticals CEO Seth Lederman. “We are moving forward expeditiously to initiate the RECOVERY study in the first quarter of 2019 and expect to have topline data in the first half of 2020.”
The New York-based company said Tonmya has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD.
Contact Uttara Choudhury at uttara@proactiveinvestors.com
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