Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) watched its shares take a handy jump early on Thursday, following positive results from its mid-stage post-traumatic stress disorder (PTSD) study. The company announced top-line results for its Phase 2 dose-finding clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in military-related PTSD (AtEase Study).
The primary efficacy endpoint was the 12-week mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between those treated with TNX-102 SL and those receiving placebo. The CAPS-5 is a standardized structured clinical interview and serves as the gold standard in research for measuring the symptom severity of PTSD.
The goal of the AtEase Study was to evaluate the potential clinical benefit of using TNX-102 SL to treat military-related PTSD at a dose of 2.8 mg or 5.6 mg. The retention rate was higher than typical for a PTSD clinical trial, since 73% completed the study on placebo, 79% on TNX-102 SL 2.8 mg and 84% on TNX-102 SL 5.6 mg.
Although the 2.8 mg dose trended in the direction of a therapeutic effect, it did not reach statistical significance on the primary endpoint. In contrast, the 5.6 mg dose had a therapeutic effect as assessed by the CAPS-5, which was statistically significant, even though this arm of the study was designed to include half the number of patients of the 2.8 mg arm.
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The AtEase Study successfully demonstrated a dose-response relationship on multiple efficacy and safety measurements. 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, which exceeded the completion rate in the placebo group.
Separately, Tonix noted that there were four distinct serious adverse events, three were in the placebo group and one (proctitis/peri-rectal abscess) in the TNX-102 SL group, reported to be unrelated to TNX-102 SL.
Seth Lederman, M.D., president and CEO of Tonix, commented:
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.
So far in 2016, Tonix has underperformed the broad markets, the stock is down 62% (prior to Thursday’s move). Over the past 52 weeks, the stock is down 53%.
Shares of Tonix closed Wednesday up 1.4% at $2.90, with a consensus analyst price target of $10.63 and a 52-week trading range of $1.85 to $10.72. Following the release of the mid-stage results, the stock was up 16% at $3.37 in early trading indications Thursday.
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