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Encaleret Showed Parathyroid Hormone-Independent Normalization of Blood and Urine Calcium in Phase 2 Proof-of-Concept Study in Post-Surgical Hypoparathyroidism
BridgeBioBridgeBio(US:BBIO) Globenewswireยท2025-09-06 18:30

Core Insights - Encaleret demonstrated significant efficacy in normalizing blood and urine calcium levels in post-surgical hypoparathyroidism patients, with 80% achieving normal levels within 5 days of treatment initiation compared to 0% on conventional therapy at baseline [1][6] - The treatment was well-tolerated, with no serious adverse events reported during the study [1] - BridgeBio plans to initiate a registrational clinical study for encaleret in chronic hypoparathyroidism in 2026 based on the promising Phase 2 results [1][3] Company Overview - BridgeBio Pharma, Inc. is focused on developing transformative medicines for genetic diseases, with a pipeline that includes early science to advanced clinical trials [5] - The company was founded in 2015 and aims to leverage advances in genetic medicine to expedite patient care [5] Study Details - The Phase 2 proof-of-concept study evaluated the PTH-independent effects of encaleret on renal calcium handling in ten participants with post-surgical hypoparathyroidism, administered at 162 mg twice daily for up to 5 days [2] - Calcitriol was stopped one day prior to the first dose, and calcium levels were titrated based on blood calcium after starting encaleret [2] Additional Findings - Encaleret treatment resulted in a rapid and sustained reduction in fractional excretion of calcium in nine participants, supporting its potential as an orally-administered treatment option for chronic hypoparathyroidism [6] - Data from preclinical studies of infigratinib were also presented, showing significant improvements in bone growth and skull development in relevant mouse models, indicating broad potential for treating skeletal conditions [4]