Tonix Pharmaceuticals CEO Dr Seth Lederman recently joined Steve Darling from Proactive to shed light on the latest developments in their research efforts. The company has successfully concluded the clinical phase of a Phase 3 registration-quality study for TNX-102 SL, a drug developed for the management of fibromyalgia.
This study, which is double-blind and placebo-controlled, saw the enrollment of 457 patients across various sites in the United States.
Lederman conveyed to Proactive that the topline results from this study are anticipated by late December. Should the results be favorable, this trial is expected to be the conclusive well-controlled efficacy trial needed for the submission of a New Drug Application to the U.S. Food and Drug Administration.
The urgency and importance of this development are underscored by the fact that an estimated 6-12 million individuals in the US are afflicted with fibromyalgia, a condition that predominantly affects women.
In addition to the TNX-102 study, Lederman also discussed another significant milestone: the enrollment of the first participant in a Phase 2 study, supported by the Department of Defense, focusing on TNX-1900 for the improvement of bone health in children with autism spectrum disorder.
This investigator-initiated trial represents a foray into addressing the complex needs of children with autism, potentially offering a new therapeutic avenue to enhance their quality of life.
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