New 3-Year Phase 3 Data Confirmed Sustained Response to TransCon® PTH (Palopegteriparatide) Therapy in Adults with Hypoparathyroidism, Including Improvements in Biochemistries, Kidney Function, and Quality of Life

Core Insights - Ascendis Pharma announced positive long-term data from the Phase 3 PaTHway Trial for TransCon PTH, showing sustained efficacy in treating adults with hypoparathyroidism [1][4] - The trial demonstrated significant improvements in biochemical markers, kidney function, and quality of life for patients [1][3] Group 1: Trial Details - The PaTHway Trial was a Phase 3, randomized, double-blind, placebo-controlled study involving 82 adults with chronic hypoparathyroidism, followed by an open-label extension [2] - At Week 156, 88% of patients had normal serum calcium levels, and 96% were independent from conventional therapy [3] - The trial maintained high retention rates, with 89% of participants completing the 3.5-year study [2] Group 2: Efficacy and Safety - Mean estimated glomerular filtration rate (eGFR) increased by 8.76 mL/min/1.73 m² across all participants, with a notable increase of 13.98 mL/min/1.73 m² in those with baseline eGFR < 60 [3] - Patients reported continued improvements in hypoparathyroidism-related symptoms and health-related quality of life, with normalization of 24-hour urine calcium excretion [3] - TransCon PTH treatment was well-tolerated, with no new safety signals identified and most treatment-emergent adverse events being mild or moderate [3] Group 3: Company Overview - Ascendis Pharma is a global biopharmaceutical company focused on innovative therapies using its TransCon technology platform [6] - The company aims to address unmet medical needs and improve patient outcomes through its product innovations [6]