Thursday, July 2, 2015

Tonix Pharmaceuticals Holding Corp. (TNXP) Addressing Underserved Therapeutic Indications with Three Ongoing Clinical Studies

Tonix Pharmaceuticals is a clinical-stage pharmaceutical company focused on the development of next-generation medications for disorders of the central nervous system. The company’s leading product candidate, Tonmya, is currently being evaluated in a phase III clinical study for the treatment of fibromyalgia, as well as a phase II clinical study for the treatment of post-traumatic stress disorder. Additionally, Tonix’s product pipeline includes TNX-201, which is currently being studied in a phase II proof-of-concept trial for the treatment of episodic tension-type headaches.

“Having three large, adequate and well-controlled clinical studies in high-value therapeutic indications simultaneously ongoing validates our business model of developing next generation medicines for significant unmet needs in a capital-efficient manner,” Dr. Seth Lederman, chairman and chief executive officer of Tonix, stated in a news release.

When commercialized for the treatment of fibromyalgia, Tonmya will give Tonix access to a large and relatively underserved market within the pharmaceutical industry. According to the Centers for Disease Control and Prevention, fibromyalgia affects an estimated five million Americans. Recent evidence suggests that poor sleep quality likely plays a fundamental role in the development and persistence of the disorder, which is characterized by chronic widespread pain and abnormal pain processing. Tonmya addresses this issue by performing as a low-dose sleep aid to improve quality of rest, effectively minimizing the effects of fibromyalgia symptoms. Top-line data from the company’s ongoing clinical study is expected in the second half of 2016.

In June, Tonix substantially increased its potential for short-term growth within the pharmaceutical industry by initiating its phase II study of TNX-201. Designed to establish efficacy and safety evidence to support future studies, the results of this trial could clear the way for the continued development of the first new prescription pharmaceutical approved to treat episodic tension-type headaches in more than 40 years.

“Approximately 75 million people in the U.S. suffer from frequent episodic tension-type headache, a condition that is estimated to be three times as prevalent as migraine,” continued Lederman. “If approved by the FDA, TNX-201 may become the only non-narcotic prescription medicine for episodic tension-type headache.”

Moving forward, Tonix’s promising product pipeline could provide a formidable platform for the company to realize tremendous market growth. For prospective shareholders, the company’s ongoing clinical trials and the immense market potential of its drug candidates combine to make Tonix an intriguing investment opportunity in the months to come.

For more information, visit www.tonixpharma.com

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