Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) sagged Tuesday after the company completed positive pre-IND meeting with the FDA for TNX-102 SL as a clinical candidate for agitation in Alzheimer's disease.
The New York-based Tonix recently held a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss its proposed development of TNX-102 SL, the Company's patented sublingual tablet formulation of cyclobenzaprine hydrochloride (CBP) for bedtime use for the treatment of agitation in Alzheimer’s disease (AAD). TNX-102 SL is currently in Phase 3 development for the treatment of post-traumatic stress disorder (PTSD).
Said CEO Seth Lederman, "We are excited by our positive dialogue with FDA regarding the potential clinical utility of TNX-102 SL for agitation in Alzheimer’s disease. Based on FDA’s feedback, Tonix has the data needed to file an IND to support a potentially pivotal efficacy study. We plan to submit the TNX-102 SL IND for agitation in Alzheimer’s disease in the first quarter of 2018."
Dr. Lederman continued, "We believe TNX-102 SL has the potential to treat agitation in Alzheimer’s disease by improving sleep quality. It is anticipated that the development and approval of TNX-102 SL for agitation in Alzheimer’s disease will benefit from the development program for PTSD."
Tonix is developing innovative pharmaceutical and biological products to address public health challenges and diseases with significant unmet needs.
Tonix shares approached noon ET Tuesday at $3.65, which was three cents lower than Monday’s close
