--News Direct--
Tonix Pharmaceuticals CEO Dr Seth Lederman joined Steve Darling from Proactive to delve into the significant development involving the US Food and Drug Administration (FDA)'s clearance of the Investigational New Drug (IND) application for TNX-2900. This innovative drug represents a proprietary magnesium-enhanced formulation of intranasal oxytocin, designed to address Prader-Willi syndrome (PWS) in children and adolescents.
Dr Lederman was quick to highlight the importance of this milestone, noting that TNX-2900 had already been granted Orphan Drug designation by the FDA back in 2022. The IND clearance paves the way for a crucial Phase 2 study, aimed at determining the optimal dosage for TNX-2900 in treating PWS.
This study will involve approximately 36 PWS patients, thoughtfully divided into four distinct groups, each comprising around nine patients. Within these groups, one will receive a placebo, while the remaining three will be administered varying dosage regimens of TNX-2900.
Tonix Pharmaceuticals' strategic plan includes the intention to collaborate with a partner to further advance TNX-2900 through its clinical development for PWS. This collaborative effort underscores the commitment to addressing a pressing medical need, as PWS stands out as the most common genetic cause of life-threatening childhood obesity.
Importantly, PWS affects both males and females equally, spanning all races and ethnicities.
This complex syndrome arises due to the absence of expression of specific genes located on the paternally acquired chromosome 15.
In essence, this groundbreaking development in the treatment of Prader-Willi syndrome represents a significant step forward in the pursuit of better outcomes for children and adolescents grappling with this challenging condition, demonstrating Tonix Pharmaceuticals' dedication to advancing medical science and improving the lives of those affected by rare diseases.
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