SFEBES2026 Oral Poster Presentations Bone and Calcium (4 abstracts)
Efficacy and Safety of Palopegteriparatide Treatment in Adults With Hypoparathyroidism: 3-Year Results From the Phase 3 PaTHway Trial
Neil Gittoes 1 , Aliya Khan 2 , Bart Clarke 3 , Mishaela Rubin 4 , Peter Schwarz 5 , Dolores Shoback 6 , Claudia Gagnon 7,8 , Andrea Palermo 9,10 , Lisa Abbott 11 , Lynn Kohlmeier 12 , Elena Tsourdi 13 , Filomena Cetani 14 , Rajesh Jain 15 , Carol Zhao 16 , Bryant Lai 16 , Michael Makara 16 , Jenny Ukena 16 , Christopher Sibley 16 , Aimee Shu 16 & Lars Rejnmark 17
1Centre for Endocrinology, Diabetes and Metabolism, University of Birmingham and Queen Elizabeth Hospital, Birmingham, United Kingdom; 2McMaster University, Hamilton, Canada; 3Mayo Clinic, Rochester, USA; 4Columbia University, New York, USA; 5Rigshospitalet, Copenhagen, Denmark; 6UCSF/VA Medical Center, San Francisco, USA; 7CHU de Québec-Université Laval Research Centre, Quebec City, Canada; 8Canada and Department of Medicine, Université Laval, Quebec City, Canada; 9Unit of Metabolic Bone and Thyroid Disorders, Fondazione Policlinico Campus Bio-medico, Rome, Italy; 10Unit of Endocrinology and Diabetes, Campus Bio-medico University, Rome, Italy; 11Northern Nevada Endocrinology and University of Nevada, Reno, USA; 12Endocrinology and Spokane Osteoporosis, Spokane, USA; 13Technische Universität Dresden Medical Center, Dresden, Germany; 14University of Pisa, Department of Clinical and Experimental Medicine, Endocrine Unit, Pisa, Italy; 15University of Chicago, Chicago, USA; 16Ascendis Pharma Inc, Palo Alto, USA; 17Aarhus University Hospital, Aarhus N, Denmark
Introduction: Palopegteriparatide is a prodrug of PTH(1-34), administered once daily, designed to provide active PTH within the physiological range for 24 hours/day. It is approved in the US, EU, UK and several other countries.
Methods: This analysis evaluated the long-term efficacy and safety of palopegteriparatide in adults with chronic hypoparathyroidism through week 156 of PaTHway, a phase 3 trial with a 26-week randomized, double-blind, placebo-controlled period, followed by an open-label extension.
Results: At week 156, 89% (73/82) of participants remained in the trial; of those, 96% were independent from conventional therapy (no active vitamin D and ≤600 mg/day elemental calcium) and 88% had normal albumin-adjusted serum calcium (2.07-2.64 mmol/l) with mean (SD) of (2.2 (0.2) mmol/l). Mean (SD) serum phosphate (1.1 (0.2) mmol/l) and calcium x phosphate product (2.5 (0.4) mmol2/l2) remained within normal ranges. Mean (SD) eGFR was 78.0 (14.5) mL/min/1.73 m2, reflecting a mean (SD) increase of 8.8 (11.9) mL/min/1.73 m2 from baseline (P <0.0001); 59% and 43% of participants had an increase in eGFR of ≥5 mL/min/1.73 m2 and ≥10 mL/min/1.73 m2, respectively. Mean (SD) 24-hour urine calcium levels normalized with palopegteriparatide treatment, remaining below the upper limit of normal (≤250 mg/day) through week 156 (162.1 [117.8] mg/day). TEAEs were mostly grade 1 or 2, with no new safety signals identified.
Conclusion: Through year 3 of the PaTHway trial, retention rate was high and palopegteriparatide demonstrated consistent longer-term safety and efficacy, which included the maintenance of serum and urine biochemistries within normal levels and sustained improvement in renal function.
Volume 117
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Endocrine Abstracts
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