PaTHway Phase 3 Trial Analysis slide image

PaTHway Phase 3 Trial Analysis

TransCon PTH PATHway Trial Top-Line Data at Week 26 Pathway TRIAL PaTHway Trial met primary and all key secondary endpoints 78.7% of patients (48 of 61) treated with TransCon PTH achieved the primary endpoint, compared to 4.8% (1 of 21) of patients in the control group (p-value <0.0001) Statistically significant improvements observed on all key prespecified secondary endpoints compared to control: HPES Symptom measures: Physical domain score (p-value = 0.0038) and Cognitive domain score (p-value = 0.0055) HPES Impact measures: Physical Functioning domain score (p-value = 0.0046) and Daily Life domain score (p-value = 0.0061) SF-36v2Ⓡ - Physical Functioning subscale score (p-value = 0.0347) TransCon PTH was generally well tolerated, with no discontinuations related to study drug 82% of TransCon PTH patients and 100% of patients in control group reported treatment-emergent adverse events (TEAEs), the majority of which were Grade 1, 2 in severity. One serious related TEAE in the TransCon PTH arm was reported due to a dosing error One death in the TransCon PTH arm was assessed as unrelated to study drug TransCon PTH-treated patients showed a mean decrease in 24-hour urine calcium excretion into the normal range, from 390 mg/24 hours down to 220 mg/24 hours 3 HPES, Hypoparathyroidism Patient Experience Scales. TransCon PTH is an investigational product candidate. For investor communication only. Not for use in product promotion. Not for further distribution. ascendis pharma
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