FDA Grants Clearance of IND for TNX-102 SL from Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) To Treat Alcohol Use Disorder (AUD)

Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) boasts of a wide portfolio of central nervous system (CNS) and immunology product candidates. The latter candidates include vaccines, which prevent infectious diseases and biologics addressing autoimmune diseases. In the recent past, the company has turned its focus on more than 36 million adults in the United States suffering from alcohol use disorder (AUD).

Tonix has been working on a treatment, TNX-102 SL, for helping the said population and has reported having received clearance of its Investigational New Drug (IND) from the FDA. The clearance means it can initiate a Phase 2 proof-of-concept study of the treatment in anticipation of its qualification for the 505(b)(2) pathway.

The Mechanism of Action of TNX-102 SL is to Improve Quality of Sleep   

Alcohol use disorder (AUD) is a chronic relapsing brain disease. Its primary symptoms include loss of control over alcohol intake, compulsive alcohol use, and sleep disturbances. All these together have a significant impact on cognition, mood, and the ability to recover, and in the long, they have an emotional influence on a person’s quality of sleep.

However, the CEO of Tonix, Seth Lederman, says chances of improving the quality of sleep in people suffering from AUD are still high, thanks to the mechanism of action of TNX-102 SL.

Inspiring results from the preclinical trials of TNX-1900 and other Vaccine Candidates 

TNX-1900 is an oxytocin solution for intranasal delivery and is associated with the ability to relieve pain from traumatic brain injury occasioned by depressive behavior. According to Lederman, preclinical data from this candidate was inspiring. The results were posted at the American Academy of Neurology’s first-ever Sports Concussion Conference during a virtual meeting.

In other news, Tonix has also joined the race of finding a possible vaccine for the devastating COVID-19. Its lead candidate is TNX-1800*, a live replicating vaccine based on the horsebox viral vector platform. The candidate is currently under animal study, and results are expected in Q4 of 2020. Meanwhile, the company is watching out on a second live replicating vaccine candidate, TNX-2300*, for the prevention of COVID-19. However, this one will be using bovine parainfluenza as the vector.