Ascendis Pharma A/S announced positive Week 26 topline results from its Phase 2 New InsiGHTS trial, evaluating once-weekly TransCon hGH (lonapegsomatropin) in prepubertal children with Turner syndrome. The trial achieved its primary objective, demonstrating a safety and tolerability profile comparable to daily somatropin.
The results showed that annualized height velocity at Week 26 was similar in children treated with once-weekly TransCon hGH and those treated with daily somatropin. This data represents the first clinical trial of TransCon hGH in an indication outside of growth hormone deficiency, highlighting the potential for broader application.
These positive outcomes lay the foundation for Ascendis Pharma's planned basket trial in 2025, which aims to support a label expansion for TransCon hGH. Expanding the indications for SKYTROFA could significantly increase its market potential and solidify its position as a leading growth hormone therapy.
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