Shares in Tonix Pharmaceuticals fell as much as nearly 50 percent Tuesday after the company reported that a Phase III study of TNX-102 SL in patients with fibromyalgia failed to achieve statistical significance for the primary efficacy endpoint. CEO Seth Lederman said "despite achieving clinically meaningful results" from the trial, "we have greater clarity on the regulatory path forward in our [post-traumatic stress disorder] programme." Lederman added "we will therefore discontinue the fibromyalgia programme."
In the AFFIRM study, 519 patients with fibromyalgia were randomised to 12 weeks of once-daily treatment with TNX-102 SL or placebo at bedtime. The main goal of the trial was the proportion of patients who experienced an at least 30-percent reduction in pain versus baseline, while the efficacy of TNX-102 SL was also examined using the Patient Global Impression of Change (PGIC) and Fibromyalgia Impact Questionnaire-Revised (FIQ-R).
Tonix noted that while no difference in the proportion of 30-percent responders was noted between the study groups in the top-line results, significance in favour of TNX-102 SL was identified in assessments of both PGIC and FIQ-R. Statistically significant effects for TNX-102 SL were also recorded for other secondary endpoints, including seven-day pain recall, fatigue, sleep quality and sleep disturbance.
In May, Tonix announced plans to meet with the FDA to finalise its late-stage development programme for TNX-102 SL for post-traumatic stress disorder after the therapy exhibited efficacy in a Phase II study. TNX-102 SL is a sublingual tablet formulation of cyclobenzaprine.
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