Tonix Pharmaceuticals Reports Third Quarter 2018 Financial Results and Operational Highlights New Phase 3 Trial of Tonmya for the Treatment of PTSD to Commence First Quarter 2019


“We are pleased to be initiating a new Phase 3 study of Tonmya* for the treatment of PTSD in the first quarter of 2019”, said Seth Lederman, M.D., President and Chief Executive Officer. This new Phase 3 study has several innovative design features that are based on retrospective analyses of data from the Phase 3 HONOR and Phase 2 AtEase studies, in addition to feedback received from the FDA during a Breakthrough Therapy Clinical Guidance meeting in October. It has been preliminarily accepted by the FDA as a potential Received the U.S. Food and Drug Administrations (FDA) preliminary agreement on the new PTSD Phase 3 study design in October. The new Phase 3 study of Tonmya will begin in the first quarter of 2019 and will have several innovative design features including: restricting enrollment to individuals with PTSD who experienced an index trauma within nine years of screening; enrolling participants who have experienced civilian traumas, in addition to participants whose traumas are military-related; and a CAPS-5 primary endpoint assessed at Week 4 instead of at Week 12, the end of the treatment period. This new 12-week study will require a baseline CAPS-5 score of 33 for enrollment, as was New composition of matter patent was issued in November which expands the Companys intellectual property protection for Tonmya, or TNX-102 SL, in the U.S. The patent is part of an expanding portfolio of patents and patent applications and other intellectual property addressing the formulation, manufacturing, and uses of Tonmya, or TNX-102 SL, …

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Source: US SEC
View full document: EX-9901_of_8-K_for_Tonix_Pharmaceuticals_Holding_Corp__8-K-11-09-2018