Clinical-stage pharmaceutical company Tonix Pharmaceuticals Holding Corp. in conjunction with announcing its second quarter 2015 financial results, reports progress in developing next-generation medicines for treating fibromyalgia, post-traumatic stress disorder (PTSD), and episodic tension-type headache.
“In the first half of this year, we achieved our goal of initiating efficacy studies in tension headache, post-traumatic stress disorder, and fibromyalgia, all large therapeutic indications,” comments Tonix’s chairman and CEO Seth Lederman, M.D. “We look forward to reporting results from each of these three trials in 2016 as we advance our programs through the clinical development process.”
Tonix ended the June 30, 2015 quarter with $48.m7 million in cash and cash equivalents, and raised $18.7M in net proceeds from an underwritten offering completed in July 2015.
Recent Clinical Highlights and Upcoming Milestones Reported
Tonix commenced a 500-patient Phase 3 AFFIRM clinical study of Tonmya (cyclobenzaprine HCl sublingual tablets, 2.8 mg), its an investigational medication candidate for treating fibromyalgia, that may help improve fibromyalgia symptoms and sleep quality, in May, 2015. The clinical study, called AFFIRM, is a randomized, double-blind, placebo-controlled, 12-week trial of Tonmya taken sublingually at bedtime daily.
The primary efficacy endpoint is a 30 percent pain responder analysis at week 12, and Tonix expects to report top-line results during the second half of 2016, noting that fibromyalgia afflicts an estimated five to 15 million Americans, with physicians and patients reporting widespread dissatisfaction with currently marketed fibromyalgia therapeutics.
An estimated five to 15 million Americans are affected by fibromyalgia, a condition characterized by chronic by widespread pain, aching and tenderness in all parts of the body. In addition, people with fibromyalgia often awaken tired and struggle with extreme exhaustion and fatigue, even though they may report sleeping for long periods of time. Although fibromyalgia is not degenerative or life threatening, anyone afflicted with the syndrome knows the toll it can take on one’s day-to-day life and sense of well-being, impacting virtually everything from work performance, to family life, to social interactions.
While the exact cause of fibromyalgia is unknown, evidence shows that fibromyalgia may be related to how the brain reacts to pain signals, causing pain to be processed and experienced at higher levels than normal.
AFFIRM Clinical Study affiliated doctors at select centers throughout the U.S. are currently accepting participants for the trial. Persons who choose to join the study receive all study-related care at no cost, with their fibromyalgia condition and overall health closely monitored by a team of physicians and study staff. Study participants will be asked to meet with their study doctor approximately 6 times over a 3-4 month period to provide feedback about their experiences. Participants may also be compensated for time and travel associated with attending these visits
To be eligible for participation in the AFFIRM Clinical Study you must be between the ages of 18 and 75 years old and living with fibromyalgia. To see if you might qualify for the AFFIRM Study, and to be referred to the fibromyalgia study center in your area, the next step is taking the pre-screening questionnaire. To see if you might qualify, and to be connected with the AFFIRM study center in your area, visit:
http://www.affirmstudy.com/do_I_qualify.htm
Other clinical trials of investigational Tonix medicines are a 220-patient Phase 2 AtEase clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for treating military-related post-traumatic stress disorder (PTSD) that commence in January 2015. AtEase is a randomized, double-blind, placebo-controlled, 12-week trial of TNX-102 SL 2.8 mg and 5.6 mg taken sublingually at bedtime daily. The primary efficacy endpoint will evaluate performance of TNX-102 SL 2.8 mg on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Tonix expects to report top-line results of the AtEase study in the first half of 2016. PTSD afflicts approximately 8.5 million Americans, and its prevalence in the military population is higher than that among civilians. Tonix notes that both of the drugs currently approved by the U.S. Food and Drug Administration (FDA) for this disorder lack evidence of efficacy in combat-related PTSD and carry suicidality warnings. To learn more, visit: http://www.ateasestudy.com
Tonix has also commenced a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept (POC) study to evaluate the potential benefit of its TNX-201 (dexisometheptene mucate) investigational drug in treating episodic tension-type headache according to a variety of efficacy measures, as well as safety and tolerability. Target enrollment is 200 patients, and the company expects to report top-line results during the first quarter of 2016.
Tonix notes that millions of Americans suffer from episodic tension-type headache, yet prescription medications are limited for the many who find over-the-counter options to be inadequate. All of the currently FDA-approved prescription drugs for this condition contain a barbiturate, and no new prescription medication for tension-type headache has been approved in over 40 years. To learn more, visit:
http://www.clinicaltrials.gov (NCT02423408).
Second Quarter Financial Results
For the three months ended June 30, 2015, Tonix reported a net loss of $11.8 million, or $0.73 per share, as compared to a net loss of $6.0 million, or $0.61 per share, for the second quarter of 2014. The higher net loss was primarily due to increased research and development expense for clinical studies and related research as well as increased general and administrative expense to support these and other corporate development activities. Cash used in operations was $18.3 million for the six months ended June 30, 2015, as compared to $9.8 million for the six months ended June 30, 2014. At June 30, 2015, Tonix’s cash and cash equivalents totaled $48.7 million as compared to $38.2 million at December 31, 2014.
About Tonix Pharmaceuticals Holding Corp.
More information about Tonix can be found at:
http://www.tonixpharma.com
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Tonix Pharmaceuticals Holding Corp.
AFFIRM Clinical Study
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Tonix Pharmaceuticals Holding Corp.