With the commencement of enrolment for the pivotal Phase III HONOR study of TNX-102 SL in military-related, post-traumatic stress disorder (PTSD), the future of Tonix (NASDAQ:TNXP) is squarely in its hands. The study 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 are “statistically persuasive” only one study may be needed for approval. The interim analysis is expected in H118 with full data in H218.
Data In 2018
The HONOR study began enrolling patients in Q117 with an interim analysis encompassing 275 patients (50% of the 550 total expected). The trial may be stopped after the interim analysis 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.
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