PaTHway Phase 3 Trial Analysis
Primary Composite Endpoint at Week 26
Pathway
TRIAL
TransCon PTH
(N = 61)
48
Placebo
(N = 21)
1
4.8% (0.1%, 23.8%)
Number of Patients Meeting The Primary Endpoint Criteria at Week 26 (responders)
Proportion (95% CI), %
Hypothesis Test: p-value (TransCon PTH vs Placebo) 1
Number of Patients Meeting Each Component, (n):
Albumin-adjusted sCa within the normal
range
2
78.7% (66.3%, 88.1%)
Independence from active vitamin D
Independence from therapeutic doses of calcium supplements
No increase in prescribed study drug
Three patients with missing data for at least one of the components are considered as non-responders.
<0.0001
49
10
60
5
57
1
57
12
TransCon PTH demonstrated a response rate of 78.7% compared to 4.8% for control (p-value <0.0001)
1 CMH test controlling for etiology of hypoparathyroidism (post-surgical vs other).
2 The normal range for albumin-adjusted sCa is 8.3-10.6 mg/dL (2.07-2.64 mmol/L).
Patients with missing data on one or more of the criteria are considered as non-
responders.
16 Data on file, Ascendis Pharma 2022.
TransCon PTH is an investigational product candidate.
For investor communication only.
Not for use in product promotion. Not for further distribution.
ascendis
pharmaView entire presentation