Tonix Pharmaceuticals’ IND Application for TNX-2900 Receives the US FDA’s Approval for the Treatment of Prader-Willi Syndrome (PWS)
- The IND application was approved based on the preclinical analysis of TNX-2900 depicting the ability of Mg2+ to enhance the potency of oxytocin in animal models as Mg2+-potentiation eliminated the high-dose suppression of oxytocin’s inverted “U”-shaped dose-response
- Following the IND approval, the company plans to initiate a P-II clinical trial evaluating TNX-2900 vs PBO in the ratio of 3:1 in PWS patients (n=36) divided into 4 cohorts. The company intends to collaborate with other companies to advance the clinical development of TNX-2900
- TNX-2900 is designed based on Tonix’s patented intranasal potentiated oxytocin formulation. Additionally, TNX-2900 received the US FDA’s Orphan Drug Designation in 2022
Ref: Tonix Pharmaceuticals | Image: Tonix Pharmaceuticals
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