TransCon® hGH (lonapegsomatropin)

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TransCon® hGH Boosted Treatment Benefits of TransCon® CNP in Children with Achondroplasia at Week 26 Interim Analysis of the Phase 2 COACH Trial
Globenewswire· 2025-06-09 11:00
Core Insights - Ascendis Pharma announced positive interim results from the COACH Trial, demonstrating that the combination of TransCon CNP and TransCon hGH significantly improves growth and body proportionality in children with achondroplasia after 26 weeks of treatment [2][4][12] Group 1: Clinical Trial Results - For treatment-naïve children, the combination treatment resulted in a mean annualized growth velocity (AGV) of 9.14 cm/year, with a height Z-score improvement of +0.53 over 26 weeks [1][12] - For children previously treated with TransCon CNP, the mean AGV was 8.25 cm/year, with a height Z-score improvement of +0.44 over the same period [1][12] - The combination treatment led to accelerated improvement in body proportionality, aligning with increased linear growth [1][12] Group 2: Safety and Tolerability - The safety and tolerability profile of the combination treatment was consistent with that of the individual monotherapies, with generally mild treatment-emergent adverse events (TEAEs) reported [1][4][12] Group 3: Trial Design and Future Plans - The COACH Trial is a Phase 2 open-label trial investigating the efficacy, safety, and tolerability of the combination treatment in children aged 2 to 11 years with achondroplasia [5] - The interim analysis will be followed by Week 52 data, expected in Q4 2025, with plans to initiate a Phase 3 trial in the same timeframe [5][11] Group 4: Product Information - TransCon CNP is under priority review by the FDA as a monotherapy for children with achondroplasia, while TransCon hGH is already approved and marketed as SKYTROFA for pediatric growth hormone deficiency [3][10] - Both products utilize Ascendis Pharma's innovative TransCon technology platform, which aims to provide sustained release of active compounds [3][10]