Tonix Plans Regulatory Filing To Kick Off Study Of Alcohol Use Disorder Drug

Shares of nano-cap biotech Tonix Pharmaceuticals Holding Corp TNXP were volatile Thursday morning following an announcement concerning its pre-investigational new drug application meeting with the U.S Food and Drug Administration.

Following the receipt of the minutes of the Type B, pre-IND meeting with the FDA, Tonix said the agency provided guidance and feedback supporting its clinical development plans for TNX-102 SL, a potential treatment for alcohol use disorder (AUD).

The company said it now plans to submit an IND application in the first quarter of 2020 that would support a Phase 2 proof-of-concept study.

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Why It's Important For Tonix And AUD

About 36 million adults in the U.S. are estimated to have AUD, which is a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake and a negative emotional state when not using alcohol.

Tonix believes the rate of successful recovery after detox can be improved by improving sleep quality.

TNX-102 SL, the company's lead compound, is also being evaluated for post-traumatic stress disorder, or PTSD, fibromyalgia and agitation in Alzheimer's disease.

For PTSD, TNX-102 SL is in Phase 3 development. The company expects to report interim and top-line results from the study next year.

Tonix shares traded higher by nearly 10% in Thursday's pre-market session, but were down more than 9% to $1.32 at at time of publication.