Tonix Anticipates Launch of Key Depression, Cocaine Intoxication Trials
Tonix Pharmaceuticals is having an exciting 2022, with aspirations to continue strategic moves through the remainder of the year. The New-York based company announced a mid-stage study for major depressive disorder (MDD), which followed the June disclosure of a planned Phase II study for a cocaine intoxication therapy.
Plans are in the works to conduct a Phase II study of experimental extended-release (ER) treatment TNX-601 ER, or tianeptine oxalate extended-release, as a potential treatment for MDD. TNX-601 ER sets itself apart from the usual selective serotonin reuptake inhibitor (SSRI) treatment regimens with a formulation unseen in FDA-approved drugs.
SSRIs and other antidepressants often come with adverse effects such as impaired sexual function, changes in sleep patterns, metabolic changes and cognitive impacts such as sedative-like feelings. Unlike SSRIs, TNX-601 ER is believed to upregulate synaptic plasticity and improve stress-related impairments that are linked to depression. The formulation and drug delivery design are also intended to help prevent misuse of the treatment.
“TNX-601 ER is a naloxone-free tablet formulated with inactive ingredients that we believe will make the tablet more difficult to adulterate for misuse and abuse, while maintaining extended-release characteristics, even if the tablet is subjected to physical manipulation, and/or chemical extraction,” Seth Lederman, M.D., president and CEO of Tonix, explained. “The potentially abuse deterrent ingredients include gel forming polymers which impede extraction, and excipients which cause nasal irritation. In addition, the tablet’s hardness makes it difficult to crush, cut or grind to fine particle size, which hinders efforts to misuse by insufflation or intravenous routes.”
The timeline places study initiation in the first quarter of 2023, provided the U.S. Food and Drug Administration (FDA) approves the Investigational New Drug application the company filed for TNX-601 ER in MDD. In addition to MDD, the asset is being investigated for its potential to treat posttraumatic stress disorder and corticosteroid use-related neurocognitive dysfunction disorders.
Phase II Trial for Cocaine Intoxication also Planned
Tonix is also working to bring another asset, TNX-1300, to commercialization as a treatment for cocaine intoxication. A Phase II study is in the works with an improved study design after the company learned that participants’ previous use of naloxone doesn’t interfere with investigating the safety and efficacy of TNX-1300. Following the results of reproductive toxicology studies, Tonix is also expected to permit the enrollment of women into the study.
The FDA is currently reviewing the new study design. If approved, this phase II study will be initiated later this year.
Lederman explained the motivation behind developing the first cocaine intoxication treatment.
“There are approximately 505,000 emergency room visits annually involving cocaine use, with approximately 61,000 of the visits involving detox services to treat cocaine overdose. In 2020, about 19,447 overdose deaths involving cocaine occurred in the U.S.,” he said. “We believe that TNX-1300 has the potential to be a new treatment option for the substantial morbidity and mortality caused by cocaine intoxication.”
Tonix is on track for a pivotal development year. Just last month, the company opened a new facility in Dartmouth, Massachusetts that will be the site of an Advanced Development Center (ADC). Within this center, experimental vaccine manufacturing will take place along with R&D activities.