Item 7.01

Tonix Pharmaceuticals Holding Corp (the “Company”) issued a press release announcing topline results from its Phase 3 RECOVERY study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6mg product candidate for the treatment of posttraumatic stress disorder (“PTSD”) and outlined future development plans. A copy of the press release is furnished as Exhibit 99.01 hereto and incorporated herein by reference.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.01 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

On December 21, 2020, the Company announced topline results from its Phase 3 RECOVERY study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of civilian and military-related PTSD. The RECOVERY study did not achieve statistical significance in the prespecified primary efficacy endpoint of change from baseline to Week 12 in the Clinician-Administered PTSD Scale for DSM-5 (“CAPS-5”) between TNX-102 SL and placebo (p=0.343) (Table 1). In the primary analysis, TNX-102 SL subjects achieved a 20.7 unit reduction in CAPS-5 versus 18.5 units for placebo. TNX-102 SL separated from placebo in the first key secondary endpoint, Clinical Global Impression – Severity (CGI-S) scale (p=0.024) (Table 1) and in the Patient Global Impression of Change (PGIC), (p=0.007). TNX-102 SL also trended for improvement on the PROMIS Sleep Disturbance scale (p=0.055), consistent with the proposed mechanism of targeting the PTSD sleep disturbance (Table 1). Among completers, there was a 58% observed mean reduction in symptoms in the active group compared to 49% in the placebo group, as measured by CAPS-5 total. TNX-102 SL is generally well tolerated and no new safety signals were observed.

Given the complexity of PTSD as a syndrome and the demonstrated potential of TNX-102 SL to improve sleep quality in PTSD, the Company plans to meet with the U.S. Food and Drug Administration (“FDA”) to discuss a proposed new indication: TNX-102 SL for the treatment of sleep disturbance associated with PTSD. Sleep disturbance is a core symptom of PTSD and believed to play roles in onset, consolidation and chronicity. Treating sleep disturbance is recognized as a clinically valid approach for addressing global improvement in PTSD. This new direction is supported by consistent results observed from all three registration-quality studies of TNX-102 SL in PTSD showing trends or nominal benefits in treating sleep disturbance, global improvement by patient self-rating or by clinician-rating. These results included female-predominant, civilian PTSD in the RECOVERY study and male-predominant, military-related PTSD in the Phase 2 AtEase and Phase 3 HONOR studies.

TNX-102 SL’s tolerability profile has been expanded by the RECOVERY study, and treatment with TNX-102 SL was not associated with weight gain or sexual side effects, and TNX-102 SL treatment notably trended towards improvement of female sexual function in RECOVERY (Table 3). This tolerability profile has the potential to differentiate TNX-102 SL from the reported tolerability of the two SSRIs that are currently FDA-approved for PTSD.

Table 1. RECOVERY study: Primary and Secondary Efficacy Endpoints

99.01 Press release of the Company, dated December 21, 2020

Tonix Pharmaceuticals Holding Corp. Exhibit
EX-99.01 2 ex99-01.htm PRESS RELEASE   TONIX PHARMACEUTICALS HOLDING CORP. 8-K   Exhibit 99.01       CONFIDENTIAL – NOT FOR DISTRIBUTION   Tonix Pharmaceuticals Reports Topline Results from Phase 3 RECOVERY Study of TNX-102 SL in PTSD and Outlines Future Development Plans     Primary Endpoint For Full Cohort of Enrolled Participants Did Not Achieve Statistical Significance (P=0.343),…
To view the full exhibit click here

An ad to help with our costs