– The company will host a webinar on key thought leaders today, October 1 at 10:00 a.m.ET –
LYON, France and CAMBRIDGE, Mass., Oct 01, 2021 (GLOBE NEWSWIRE) – Amolyt Pharma, a global company specializing in the development of therapeutic peptides for rare and related endocrine diseases, today announced the positive results of its Phase 1 clinical trial of AZP -3601, a potential treatment for hypoparathyroidism, at the 2021 American Society for Bone and Mineral Research annual meeting. These results demonstrated that repeated administration of AZP-3601 to healthy volunteers induced a rapid and dose-dependent increase in serum calcium levels which was sustained and stable during the treatment period. In addition, no increase in urinary calcium excretion was observed and bone biomarkers remained unchanged, as expected based on the unique mechanism of action of AZP-3601 and its short half-life. pharmacokinetic life.
This data will be presented in a poster at the 2021 American Society for Bone and Mineral Research annual meeting, also available on the Amolyt Pharma website here. The company will host a Key Opinion Leaders (KOL) webinar to discuss these findings in more detail today, October 1, 2021 at 10:00 a.m.ET.
In this double-blind, randomized, placebo-controlled phase 1 clinical trial of AZP-3601, 102 healthy volunteers were recruited, including 52 in the single-dose ascending (SAD) cohorts and 50 in the multiple-dose cohorts. ascending (MAD). Data from the SAD cohort have already been reported.
Doses of 10, 20, 40, 60 or 80 µg of AZP-3601 or placebo were administered by subcutaneous injection once daily for a period of two weeks in the MAD cohort. The objectives of the trial were to assess safety and tolerability, as well as to assess the pharmacokinetics and pharmacodynamics of AZP-3601 in healthy volunteers.
AZP-3601 was generally well tolerated without any safety concerns. No serious or serious adverse events were reported.
A rapid and dose-dependent increase in serum calcium (sCa) was observed with doses of 20 µg / day and above, and was maintained during the treatment period.
A dose-dependent decrease in endogenous parathyroid hormone (PTH) consistent with the dose-dependent increase in serum calcium was also observed.
No increase in urinary calcium excretion (uCa) from baseline was observed, despite markedly increased sCa levels, indicating increased renal calcium reabsorption.
No changes in bone biomarkers were observed at any of the doses tested, reflecting a neutral effect on bone remodeling, as expected based on the unique mechanism of action of AZP-3601 and its short half-life. -pharmacokinetic life.
“We are delighted with these clinical trial results for AZP-3601 in healthy volunteers, as they support a potential therapeutic profile that we believe may meet the multiple clinical needs of patients with hypoparathyroidism, including a large number of patients affected or at risk. kidney failure, osteopenia or osteoporosis, ”said Thierry Abribat, Ph.D., founder and CEO of Amolyt Pharma. “Based on these positive results, we have started our next trial in patients. This is an important milestone in our quest to offer patients with hypoparathyroidism a potential new treatment option, and we look forward to publishing data from this new trial in the first half of 2022. ”
Title: Safety, Tolerance, Pharmacokinetics and Pharmacodynamics After Single and Multiple Administrations of AZP-3601, a New Long-Acting PTH Analog, in Healthy Adults
Amolyt will host a KOL webinar to discuss the results of Phase 1 in more detail today, October 1, 2021 at 10:00 a.m.ET. Those interested can register for the webinar here.
Hypoparathyroidism is defined by a deficiency of parathyroid hormone (PTH) which causes a decrease in the levels of calcium and phosphorus in the blood. The clinical manifestations of hypoparathyroidism vary and affect a large number of tissues and organ systems, including muscles, brain, heart and kidneys. Despite the available treatments, patients frequently experience persistent life-altering symptoms and reduced quality of life. In addition, they often develop kidney disease and exhibit abnormal bone architecture. There are approximately 80,000 and 110,000 people with hypoparathyroidism in the United States and the European Union, respectively, of which approximately 80% are women. More than two-thirds of women with hypoparathyroidism are peri- and menopausal women who are at increased risk of developing osteoporosis. It is estimated that about 25% of people with hypoparathyroidism have chronic kidney disease or kidney failure, which underscores the importance of reducing urinary calcium excretion as a key goal of treatment.
AZP-3601 is an investigational therapeutic peptide designed to target a specific conformation of the parathyroid hormone (PTH) receptor to safely produce sustained levels of calcium in the blood and thereby manage the symptoms of hypoparathyroidism. AZP-3601 is designed to be selectively active through this distinct conformation of the PTH receptor and to limit urinary calcium excretion by restoring calcium reabsorption by the kidney, thereby preventing chronic kidney disease. Additionally, AZP-3601 is designed to have a unique receptor profile and short half-life, which would have the potential to preserve bone integrity, a significant potential benefit given that the majority of patients with hypoparathyroidism are peri- and postmenopausal women who are at an increased risk of developing osteoporosis.
About Amolyt Pharma
Amolyt Pharma, a clinical-stage biotechnology company, leverages its team’s established expertise in therapeutic peptides to provide life-changing treatments for patients with rare and related endocrine diseases. Its portfolio includes AZP-3601, a long-acting PTH analogue as a potential treatment for hypoparathyroidism, AZP-3813, a peptide growth hormone receptor antagonist for the potential treatment of hypoparathyroidism. acromegaly, and AZP-3404, which is the subject of an indication selection work. Amolyt Pharma aims to expand and further develop its portfolio by leveraging its global network in the field of endocrinology and with the support of a strong union of international investors. To learn more, visit https://amolytpharma.com/ or follow us on Twitter at @AmolytPharma.
Cherilyn Cecchini, MD
LifeSci Advisors, LLC