Tonix Pharmaceuticals is reallocating resources and cash to streamline its pipeline and focus on its mid- and late-stage clinical programs within its core central nervous system portfolio. The pipeline realignment prioritizes key near-term value drivers, reduces investment in several longer-term programs, particularly COVID-19-related studies, and delays the start of a posttraumatic stress disorder study in Kenya. Key Anticipated 2023 Milestones: Interim analysis results of Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia in the second quarter of 2023. Interim analysis results of Phase 2 PREVENTION study of TNX-1900 for chronic migraine in the fourth quarter of 2023. Interim analysis results of Phase 2 UPLIFT study of TNX-601 ER for major depressive disorder in the fourth quarter of 2023. Topline results of Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia in the fourth quarter of 2023. Initiate enrollment in a potentially pivotal Phase 2 study of TNX-1300 for the emergency room reversal of the effects of cocaine intoxication. Tonix is aligning its operational and scientific efforts on its core CNS programs and deprioritizing other programs as follows: Central Nervous System: The Company is prioritizing the advancement of its late- and mid-stage clinical fibromyalgia, depression, migraine, and cocaine intoxication studies and delaying the start of the Kenya PTSD study. The Company has received regulatory clearance in Kenya, which will allow it to rapidly restart the PTSD program at the appropriate time. The Company is discontinuing the enrollment of new patients in a Phase 2 clinical trial in fibromyalgia-type Long COVID. The approximately 60 patients enrolled to date in the Long COVID study will be followed to completion, with topline data expected in the third quarter of 2023. The Company believes that the data from the study may guide future development and support grant applications. Infectious Disease: The Company is continuing to advance development of TNX-801 and its portfolio of potential broad-spectrum antiviral agents, including direct antiviral engineered proteins, TNX-4000, and the host-directed antiviral series of molecules, TNX-3900. The Company will also continue work on the recombinant pox virus platform vector technology as a platform for rapid response to new pathogens, rather than specifically on the TNX-1800/TNX-1850 vaccines for COVID-19. Near-term preclinical work on other COVID-19 related programs, including anti-COVID antibodies TNX-3600, TNX-3800 and TNX-4100, will be deprioritized. Immunology and Rare Disease: The Company is continuing development on TNX-1500, and TNX-2900, a small peptide for the treatment of hyperphagia in Prader-Willi syndrome. The FDA has granted Orphan Drug designation for TNX-2900 for PWS.
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