Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) has commenced enrolment for the Phase III HONOR study of TNX-102 SL in military-related post-traumatic stress disorder (PTSD). It is expected to enroll up to 550 patients with a CAPS-5 of ≥33 upon entry. Importantly, the FDA has agreed to an interim analysis encompassing 275 patients at which point it may be stopped for efficacy. The FDA has also indicated that if the data is “statistically persuasive” only one study may be needed for approval. The interim analysis is expected in H118 with full data in H218.
Readout expected in 2018
The HONOR study has begun enrolling patients and there will be an interim analysis encompassing 275 patients (50% of the 550 total expected) after which the trial may be stopped for efficacy (though the exact statistical hurdle rate has not been disclosed), the sample size adjusted or the study continue as planned. The interim analysis is expected in H118 with full data in H218.
To read the entire report Please click on the pdf File Below