Tonix Pharmaceuticals said that it will reduce enrollment in the recently initiated Phase 2 PREVENTION study of TNX-1900 intranasal potentiated oxytocin in migraine patients from about 300 subjects to about 150 subjects, with a goal of providing topline data by the end of 2023. As part of the company’s efforts to “streamline” two of its clinical trials, a Phase 3 trial of a sublingual drug for fibromyalgia and the TNX-1900 study, no interim analyses will be performed.
Tonix CEO Seth Lederman said, “In an effort to expedite and deliver on clinical timelines, we are modifying the designs of our confirmatory, registration-enabling Phase 3 trial in fibromyalgia and our Phase 2 trial in chronic migraine. By eliminating the interim analyses, we remove the statistical penalties associated with this type of analysis, conserve resources, and can plan on topline results for each of these studies in the fourth quarter of 2023. Fibromyalgia and migraine each affect millions of people, and we remain committed to aligning our operational and scientific efforts on these core CNS programs. We are excited to progress these programs closer to FDA approval, upon achieving positive topline data.”
The company also said that it is continuing development of TNX-2900 intranasal potentiated oxytocin for the treatment of hyperphagia in Prader-Willi syndrome.
Read the Tonix Pharmaceuticals press release.
