Amolyt Pharma Announces Oral Presentation at the 25th European Congress of Endocrinology (ECE) 2023
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Presentation highlights results from 13- and 39-week studies of eneboparatide in non-human primates demonstrating no evidence of deleterious impact on bone quantity or quality as measured by multiple bone parameters
Findings further substantiate the potential of eneboparatide as a treatment for hypoparathyroidism, where many patients suffer from, or are at risk of developing osteopenia and osteoporosis
LYON, France, and Cambridge, MA, May 11, 2023 — Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that it will deliver an oral presentation at the European Congress of Endocrinology (ECE) 2023 Annual Meeting, which is being held May 13-16 in Istanbul, Turkey.
The presentation details the results of two studies of eneboparatide in non-human primates which demonstrated no deleterious impact on bone quantity or quality as measured by multiple bone parameters at 13 and 39 weeks of treatment.
Key findings include:
- In the 13-week study, there was no evidence of a treatment effect of eneboparatide on either bone mineral density (BMD) or histopathology
- In the 39-week study, there were no significant effects of eneboparatide at any dose level on either BMD or histopathology, and analysis of blood samples for the anabolic bone biomarker, N-terminal propeptide of type 1 procollagen (P1NP), and the catabolic bone biomarker, C-terminal telopeptide (CTX), revealed no treatment-related changes.
“We are pleased to present these study results at this year’s ECE meeting as they serve to highlight a key potential benefit for patients with hypoparathyroidism – the possibility to treat the underlying disease without compromising bone quantity or quality,” said Thierry Abribat, Ph.D., founder and chief executive officer of Amolyt Pharma. “We believe the clinical profile of eneboparatide observed in trials to date gives it the potential to become the future standard of care for hypoparathyroidism, and to that end, we are eager to initiate our recently announced Phase 3 trial.”
Mark Sumeray, M.D., chief medical officer of Amolyt Pharma, added, “Many patients with hypoparathyroidism have, or are at risk of developing osteopenia or osteoporosis, so an optimal treatment for this indication must be able to control serum calcium without the need for oral calcium and vitamin D supplementation, normalize urinary calcium excretion, and avoid deleterious effect on bone. The positive results from these pre-clinical studies contribute to the significant and growing body of evidence suggesting that eneboparatide can achieve these clinical goals without deleteriously affecting bone, even when administered over an extended period. This is a critical potential benefit for eneboparatide, and we look forward to further confirming these findings in our upcoming Phase 3 Calypso clinical trial.”
Title: Eneboparatide, a Novel PTH-1 Receptor Agonist, Has No Impact on Bone Parameters Following Chronic Treatment of Non-Human Primates
Format: Oral Presentation
Session: Oral Communications 8: Calcium and Bone
Date: Monday, May 15, 2023
Time: 2:10 p.m. CEST (8:10 a.m. EDT)
The full abstract can be found here:
Hypoparathyroidism is defined by a deficiency of parathyroid hormone (PTH) that results in decreased calcium and elevated phosphorus levels in the blood. Approximately 80% of the estimated 80,000 people in the U.S. and 110,000 in the European Union with hypoparathyroidism are women. Despite available treatments, patients experience persistent, life-altering symptoms and often develop complications and comorbidities that diminish quality of life and create segments of the patient population with specific clinical needs. Clinical manifestations of hypoparathyroidism impact many tissues and organ systems, in particular, the kidneys and bone.
17% of patients with hypoparathyroidism have osteopenia or osteoporosis and 53% are peri- or postmenopausal women with an increased risk of developing osteoporosis. Approximately 26% of patients with hypoparathyroidism have chronic kidney disease or failure, highlighting the importance of reducing urinary calcium excretion as a key treatment goal.
Eneboparatide is an investigational therapeutic peptide designed to target a specific conformation of the parathyroid hormone (PTH) receptor to produce sustained and stable levels of calcium in the blood and thereby manage the symptoms of hypoparathyroidism, and to limit urine calcium excretion by restoring calcium reabsorption by the kidney, with the goal of consequently preventing chronic kidney disease. In addition to its unique receptor profile, eneboparatide is also designed to have a short half-life to potentially preserve bone integrity, an important potential benefit, since the majority of patients are peri- and postmenopausal women with an increased risk of developing osteoporosis.
About Amolyt Pharma
Amolyt Pharma, a clinical stage biotechnology company, is building on its team’s established expertise to deliver life-changing treatments to patients suffering from rare endocrine and related diseases. Its development portfolio includes eneboparatide (AZP-3601), a long-acting PTH1 receptor agonist as a potential treatment for hypoparathyroidism, and AZP-3813, a peptide growth hormone receptor antagonist for the potential treatment of acromegaly. Amolyt Pharma aims to further expand and develop its portfolio by leveraging its global network in the field of endocrinology and with support from a strong syndicate of international investors. To learn more, visit https://amolytpharma.com/ or follow us on Twitter and LinkedIn.
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