Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) can now proceed with the two Phase 3 studies of its drug candidate called TNX-102 SL in patients suffering from post-traumatic stress disorder (PTSD). TNX-102 SL is also being developed as a treatment for a condition known as fibromyalgia.
In addition to accepting Phase 3 study proposals for TNX-102 SL in PTSD patients, the FDA also said that it will accept the same chemistry, manufacturing and controls (CMC) proposals that Tonix submitted for fibromyalgia for PTSD.
Confirmation of acceptance
The FDA had earlier indicated that it would back Tonix’s proposal to escalate the trial of TNX-102 SL for PTSD to Phase 3 study. As such, the latest communication from the agency confirms its acceptance of the planned late-stage trials of TNX-102 SL in people affected by PTSD.
Military and civilians
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is gearing up to run two Phase 3 studies of TNX-102 SL in PTSD patients. The first study will target military subjects and it is expected to commence in 1Q2017. The study will be randomized, double-blind, placebo-controlled.
The study of TNX-102 SL in civilian patients with PTSD is expected to commerce later in 2017. As with the case of military study, the trial on civilians will also be randomized, double-blind and placebo-controlled.
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is targeting to recruit between 400 and 500 subjects in each of the Phase 3 studies. Patients will receive a 5.6 mg dose of TNX-102 SL or placebo on a daily basis for 12 weeks. The drug will be administered at bedtime.
Primary endpoint – Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)
The primary endpoint of the dual Phase 3 studies will be similar to the Phase 2 AtEase study of the candidate. That is mean change in severity of PTSD symptoms after 12 weeks of treatment between subjects receiving NX-102 SL and those on the control arm receiving a placebo.
Because of similarity of the primary endpoints as with the Phase 2 study, Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is confident of hitting the target with the dual late-stage studies.