Patients from the Canadian National Hypoparathyroidism Registry were prospectively screened for bone disease through DXA scan with results demonstrating significant rates of osteopenia, osteoporosis and associated fragility fractures in postmenopausal females

Analysis of translational data from pre-clinical and clinical studies of eneboparatide, a PTHR1 agonist in Phase 3 for the treatment of hypoparathyroidism, supports its ability to maintain calcium homeostasis, normalize urinary calcium and restore balanced bone turnover, while preserving bone integrity, thanks to its specific and targeted mechanism of action

Lyon, France, and Cambridge, MA, Oct. 16, 2023 - Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced data from two posters that were presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, which is being held October 13-16, 2023, in Vancouver, BC, Canada. The data include a prospective analysis of bone disease in patients with hypoparathyroidism from the Canadian National Hypoparathyroidism Registry with evidence of significant bone disease burden in postmenopausal females (PMF). In addition, data from both pre-clinical and clinical studies of eneboparatide continue to demonstrate its ability to restore balanced bone turnover, preserving bone integrity, while maintaining calcium homeostasis and normalizing urinary calcium.

“We’re very pleased to have a strong presence at this year’s ASBMR Annual Meeting. The data from our collaborative work with the team of Professor Aliya Khan at McMaster University demonstrate the extent of bone disease in patients with hypoparathyroidism and provide evidence of significant rates of osteopenia and osteoporosis, 57.5% and 25.0%, respectively, in postmenopausal females, that were associated with the presence of fragility fractures in 25.0% of them,” said Mark Sumeray M.D., chief medical officer of Amolyt Pharma. “These data underscore the need to develop a therapy for hypoparathyroidism that can restore balanced bone homeostasis and avoid bone loss that may predispose to fractures while normalizing urinary calcium and improving quality of life. Our second poster provides data from non-human primates, healthy volunteers and patients with hypoparathyroidism showing how our investigational therapeutic peptide, eneboparatide, maintains normal serum calcium and normalizes urinary calcium without evidence of harmful effects on the bone. We look forward to the results of our ongoing Phase 3 trial, “Calypso,” in which we are studying the efficacy of eneboparatide on urinary calcium as well as the impact on bone quantity and quality.”

Aliya Khan, Professor of Clinical Medicine, and Director of Calcium Disorders Clinic at McMaster University, added, “This is the first time to our knowledge that prospective screening for bone health has been performed in a representative cohort of patients with hypoparathyroidism. These data increase our understanding of the relationship between hypoparathyroidism and bone strength. A significant percentage of postmenopausal women with hypoparathyroidism have osteoporosis and fragility fracture and it will be important to ensure skeletal safety in developing new therapeutic options for these individuals.”

Title: Skeletal effects of hypoparathyroidism (HypoPT); data from the Canadian National Hypoparathyroidism Registry (CNHR)

Author/Presenter: Salma Hussein, M.D. (Clinical Fellow of Metabolic Bone Disease, McMaster University)

Title: Eneboparatide, A Novel Investigational PTH1R Agonist, Maintains Calcium Homeostasis Without Deleterious Effects on Bone

Author/Presenter: Mark Sumeray, M.D. (Chief Medical Officer, Amolyt Pharma)

Copies of the presentation materials can be accessed by visiting the “News” page of Amolyt’s website: https://amolytpharma.com/news/#presentations