Amolyt Pharma Doses First Subject in Phase 1 Clinical Trial of Parathyroid Hormone Analog, AZP-3601
LYON, France, and NEWTON, MA, October 14, 2020 (GLOBE NEWSWIRE) — Amolyt Pharma, a global clinical-stage company specialized in developing therapeutic peptides for rare endocrine and metabolic diseases, today announced that the first subject in the Phase 1 clinical trial for AZP-3601 has been dosed. AZP-3601 is currently in development for the treatment of hypoparathyroidism, a rare and potentially debilitating endocrine disorder. AZP-3601 is a parathyroid hormone (PTH) analog that targets a specific configuration of the PTH receptor, thereby inducing a prolonged increase in blood calcium levels.
“This achievement marks a significant milestone for Amolyt Pharma in the development of AZP-3601,” said Thierry Abribat, Ph.D., chief executive officer. “Current treatments for hypoparathyroidism fail not only to effectively control symptoms and to regulate 24-hour serum calcium, but also to normalize 24-hour urinary calcium, a key contributor to long-term kidney disease. AZP-3601 is a PTH analog designed to target a specific configuration of the PTH receptor to adequately control the symptoms of hypoparathyroidism, restore normal blood calcium levels and decrease urinary calcium excretion. Additionally, through its unique mechanism of action, AZP-3601 is expected to preserve bone integrity, an important advantage since hypoparathyroidism disproportionately affects peri and postmenopausal women who are at an increased risk of osteoporosis. We are implementing an ambitious and efficient Phase I program to demonstrate proof-of-concept and rapidly advance AZP-3601 for patients with hypoparathyroidism.”
The Phase 1 clinical program will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AZP-3601 following single and multiple ascending doses in healthy subjects as well as in patients with hypoparathyroidism. The healthy subject cohorts will be treated at a single clinical Phase 1 unit, while the patient cohorts will be treated at several European sites that specialize in hypoparathyroidism. Amolyt Pharma intends to enroll up to approximately 130 healthy volunteers and patients.