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Tonix shares battered as lead Fibromyalgia drug flops in PhIIb
Thursday 2 October 2014
Tonix shares battered as lead fibromyalgia drug flops in PhIIb
According to Tonix ($TNPX), TNX-102 SL flopped on the primary endpoint: a change in patients' daily pain score after 12 weeks. Investigators highlighted what they said were positive results for pain along with promising results for secondary endpoints measuring side effects like sleep disturbance, but investors weren't buying it. The New York-based biotech saw its shares plunge by 50% soon after the news hit.
Headed into the setback, Tonix had a market cap of only $147 million and looks like it will end the day well below that level. TNX-102 SL is a reformulated version of cyclobenzaprine, a muscle relaxer which is used in oral form to combat pain and stiffness in patients. Tonix has touted its sublingual formulation as a major improvement for patients and is also studying the drug for post-traumatic stress disorder.
Tonix's plan now? Head straight into a pivotal Phase III study.
"TNX-102 SL showed broad activity across key fibromyalgia symptoms in the BESTFIT study, and the treatment was well tolerated," says CEO Seth Lederman in a statement. "While the study did not achieve statistical significance on the primary endpoint, this is a very supportive study for the Phase III clinical program. Also, these findings validate our approach to develop a differentiated drug that acts beyond analgesia to improve multiple symptom domains of a complex condition."
Lederman told FierceDrugDelivery recently that he was anticipating a 2017 approval for this treatment. Investors may be recalculating that timeline today.
- here's the release
The above originally appeared here.
Tonix Pharmaceuticals has a different view of the results...
Tonix Pharmaceuticals Reports Top Line Results From Phase 2b BESTFIT Trial of TNX-102 SL in Patients With Fibromyalgia
NEW YORK, Sept. 29, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) today announced top line results of the Phase 2b BESTFIT (BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy) study of TNX-102 SL as a chronic bedtime treatment for fibromyalgia.
While the study did not achieve statistical significance in the primary efficacy endpoint of change in average daily pain score at week 12 (p=0.086 by mixed-effect model repeated measure analysis, p=0.172 by jump-to-control, multiple imputation analysis), it did demonstrate that TNX-102 SL had a statistically significant effect on pain by a 30 percent responder analysis of the primary pain data (p=0.030). BESTFIT also showed statistically significant improvements with TNX-102 SL in the key secondary analyses of the Patient Global Impression of Change (PGIC, p=0.025) and the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) total score (p=0.014). The study showed statistically significant improvement with TNX-102 SL on measures of sleep quality, including the PROMIS Sleep Disturbance instrument (p=0.003). In addition, statistically significant improvements with TNX-102 SL were observed on several FIQ-R items (pain, sleep quality, anxiety, stiffness, and sensitivity) as well as on the overall symptom subdomain.
Seth Lederman, M.D., president and chief executive officer of Tonix, commented, "TNX-102 SL showed broad activity across key fibromyalgia symptoms in the BESTFIT study, and the treatment was well tolerated. While the study did not achieve statistical significance on the primary endpoint, this is a very supportive study for the Phase 3 clinical program. Also, these findings validate our approach to develop a differentiated drug that acts beyond analgesia to improve multiple symptom domains of a complex condition. The activity of TNX-102 SL was cross-validated by two endpoints, FIQ-R and PGIC, which assess a range of fibromyalgia symptoms and global improvement. The internal consistency of these results is strongly supportive of the activity of TNX-102 SL to treat fibromyalgia, which manifests with several different symptoms." Dr. Lederman continued, "We plan to meet with the Food and Drug Administration to review the BESTFIT data and to design an acceptable Phase 3 program." Dr. Lederman concluded, "These results also support the potential clinical benefit of TNX-102 SL for the treatment of post-traumatic stress disorder (PTSD). We are confident that addressing disturbed sleep will provide a new treatment option for those suffering with PTSD and the BESTFIT data show that TNX-102 SL has strong positive effects on sleep quality."
The full article, with result graphs, appears here.
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