Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has edged closer to a major drug development breakthrough that would pave the way for massive revenue in the next few years. The company reported topline result of a Phase 2 study of its post-traumatic stress disorder (PTSD) drug candidate called TNX-102 SL. The study turned positive results in a group that consumed a higher dosage of the drug.
PTSD is a debilitating mental condition that affects millions of people around the world and it is more profound among military personnel. Therefore, success of TNX-102 SL could see millions of veterans restructure their lives positively and unlock a massive revenue opportunity for Tonix.
The Phase 2 trials
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)’s Phase 2 study enrolled patients in two groups to try TNX-102 SL at different drug dosage. One group received a 5.6 mg dose of the drug while another group receive lower dose of 2.8 mg. The number of patients enrolled in the higher dose group was half that of the lower dose group.
The study focused on assessing the potential clinical benefits of taking TNX-102 SL to tackle the effects of PTSD. The trial also helped gauge the safety of the drug.
The outcome of the study
TNX-102 SL produced a statistically significant positive effective in the patients that took the 5.6 mg dose on measurement based on CAPS-5. However, the outcome in the lower dose group underwhelmed as the effect wasn’t statistically significant relative to placebo.
In both cases, Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) reported that TNX-102 SL was well tolerated by the patients taking it.
A surprise development at Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)
Tonix is expected to release detailed results of Phase 2 study in the coming weeks as what has been reported is only topline result. Nevertheless, the fact that the 5.6 mg dosage arm fared better than the 2.8 mg group has already surprised some analysts. Given the difficult of treating PTSD, analysts had expressed doubt if the higher dosage group would turn up appealing results.
Phase 3 trial
Buoyed by the positive Phase 2 trial data, Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) will now embark on Phase 3 study of TNX-102 SL, which is expected to begin in 1Q2017. The company is also getting ready for a second Phase 3 just in case the regulator asks for it.
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) does not intend to return to the market to raise additional capital fund the remaining work on TNX-102 SL. Instead, the company will seek partnership to help it bring the drug to market.