Tonix Pharmaceuticals has announced the initiation of the Phase 2 POWER study of its TNX-1900 potentiated oxytocin nasal spray in subjects aged 12-18 whose body mass index (BMI) is in the 95th percentile or higher for their age and gender. The study, which is taking place at Massachusetts General Hospital, is expected to enroll 75 participants who will use either TNX-1900 or placebo, self-administering 1 spray in each nostril 2 times per day for 12 weeks.
Tonix CEO Seth Lederman commented, “More than two thirds of the US population suffers from obesity or is overweight. Available pharmacologic treatment options for weight loss in children are limited by safety/tolerability problems and failure to achieve sustained weight loss. It is essential to develop safe and effective therapeutic strategies for weight loss, particularly in adolescents, who are understudied while being at greatest risk for long-term comorbidities.”
Principal investigator Elizabeth A. Lawson, Director of the Interdisciplinary Oxytocin Research Program at Massachusetts General Hospital explained, “Studies in animals have shown that oxytocin, a hypothalamic peptide hormone, simultaneously reduces food intake and increases energy expenditure, leading to weight loss. Intranasal oxytocin is well-tolerated and in our studies of adults, results in reduced caloric intake, increased fat burning, and improved insulin sensitivity. The goal of the double blind POWER study is to assess whether intranasal administration of oxytocin will decrease weight as a consequence of decreased caloric intake and increased energy expenditure, and improve metabolic risk markers in adolescents with obesity.”
Tonix acquired the rights to develop TNX-1900 for the treatment of migraines from Trigemina in 2020 and licensed technology related to the use of oxytocin for the treatment of insulin resistance and obesity from the University of Geneva later that year. Earlier this year, the company initiated a Phase 2 trial of TNX-1900 for the treatment of migraines and then announced that it would “streamline” that trial by reducing enrollment.
Read the Tonix Pharmaceuticals press release.
