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Encaleret normalises mineral homeostasis in patients with ADH1

Presented by
Dr Kelly Roszko, National Institutes of Health, USA
ASN 2022
Phase 2
Data from a small study showed that encaleret was able to restore mineral homeostasis in patients with autosomal dominant hypocalcaemia (ADH1) by normalising blood calcium, intact parathyroid hormone (PTH), 24-hour urine calcium, blood phosphate, blood magnesium, and 1,25 (OH)2-vitamin D. Encaleret was well tolerated over a duration of 24 weeks without any serious adverse events reported [1].

Dr Kelly Roszko (National Institutes of Health, USA) presented the results of a phase 2b, open-label, dose-ranging study investigating the oral short-acting calcium-sensing receptor (CaSR) antagonist calcilytic (encaleret) in ADH1, a disorder of low PTH. “Conventional therapy with calcium and activated vitamin D does not correct the underlying pathophysiology and has the potential to worsen renal complications,” Dr Roszko said. The study comprised 4 periods with Dr Roszko focusing on periods 2 (5 days) and 3 (24 weeks). Encaleret was administered to 13 adults with ADH1 in period 2, followed immediately by period 3, which aimed to optimise dosing and assess safety and efficacy. The encaleret doses were titrated individually to normalise corrected blood calcium. “The results of periods 2 and 3 showed that encaleret increased mean blood calcium and PTH and decreased mean urine calcium into normal ranges. No treatment or study discontinuations occurred.” The long-term extension of the study is ongoing and a phase 3 study is planned to start in late 2022 [1].

  1. Roszko K, et al. Encaleret Normalized Mineral Homeostasis in Autosomal Dominant Hypocalcemia Type 1 (ADH1) in a Phase 2 Study. FR-OR08, ASN Kidney Week 2022, 3–6 Nov.


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