Tonix Pharmaceuticals Holding Corp., a company developing next-generation therapeutics for fibromyalgia, episodic tension-type headaches, and post-traumatic stress disorder (PTSD), is among the participants at the 18th annual BIO CEO & Investor Conference.
At the Feb. 8 conference in New York City, Tonix’s president and CEO, Seth Lederman, MD, is providing an overview of clinical studies into its fibromyalgia and other treatments, due to be reported later in 2016, as well as a corporate update.
An ongoing Phase 3 registration study is investigating TNX-102-SL, a sublingual formulation of cyclobenzaprine HCL 2.8 mg, designed to be taken at bedtime to ensure a restful sleep. The medication’s safety and efficacy have already been demonstrated in an earlier trial. Results from the randomized, double-blind, placebo-controlled AFFIRM trial are expected in the third quarter of 2016.
TNX-102-SL intends to help treat fibromyalgia symptoms by improving sleep quality. Around 90 percent of patients suffer from sleep deprivation, and evidence suggests that improving their ability to rest could be a successful therapeutic strategy.
Another drug in clinical testing, TNX-201, aims to treatment episodic tension-type headaches without barbiturates, a common medication prescribed for this condition. TNX-201 is among a new class of analgesics, known as Selective Imidazoline-1 Receptor (SIR) agonists, and has the potential to become the first single-agent prescription treatment for episodic tension-type headache in more than 40 years.
TNX-201 is currently under development in a randomized, double-blind, placebo-controlled Phase 2a proof-of-concept study, with results expected in the first quarter of 2016.
The company’s approach to treating PTSD also targets mechanisms associated with sleep disturbance. As with fibromyalgia, sleep quality is severely affected in PTSD, and it is thought that increasing sleep quality may facilitate the body’s ability to heal from trauma. TNX-102 SL is currently being studied in the randomized, double-blind, placebo-controlled Phase 2 AtEase clinical trial for the treatment of military-related PTSD, with results expected in this year’s second quarter.
The Annual Bio CEO & Investor Conference is one of the largest independent investor conferences, and focuses on both established and emerging biotech companies. It provides a forum for institutional investors, senior biotechnology executives, and industry analysts to shape investment decisions.
A webcast of the presentation will be available under the “events” tab of Investor Relations section of Tonix’s website for the next two months.