FDA Clears Phase 2 Study Of TNX-2900 In Prader-Willi Syndrome

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) Monday said it received clearance from the Food and Drug Administration (FDA) for the Phase 2 study of TNX-2900 to treat Prader-Willi Syndrome (PWS) in children and adolescents.

Prader-Willi syndrome, a rare genetic condition that affects a child's body, behavior, as well as metabolism, is considered as the most common genetic cause of life-threatening childhood obesity.

TNX-2900 is a proprietary magnesium-enhanced formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating.

The IND application for TNX-2900 was supported by preclinical data showing that Magnesium enhances the potency of oxytocin.

The Phase study is a dose finding study in which the participants are divided into four groups- 3 groups will receive different doses of TNX-2900, and the other group will receive placebo.

TNX-2900 for the treatment of PWS was granted Orphan Drug designation by the FDA in 2022.