HONOR study up and running
Tonix Pharmaceuticals 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.Tonix Pharmaceuticals Holding is a clinical-stage biopharmaceutical company focused on discovering and developing pharmaceutical products to treat serious neuropsychiatric conditions and to improve biodefense through the development of potential medical counter-measures. The company's main drug development program is focused on delivering a long-term treatment for posttraumatic stress disorder. The company's primary product candidate, Tonmya, or TNX-102 SL, is a proprietary low-dose cyclobenzaprine sublingual tablet, designed for bedtime administration. TNX-102 SL is also being developed as a treatment for agitation in Alzheimer's disease.
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