Top-line safety and efficacy data from ongoing clinical trial in patients with hypoparathyroidism expected mid-2022 LYON, France, and Cambridge, MA, March 16, 2022
Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the ongoing AZP-3601 clinical proof-of-concept trial in patients with hypoparathyroidism. The trial is currently being conducted in several European countries.
“We are pleased that the FDA has cleared our IND, allowing us to expand our AZP-3601 clinical program to the U.S., where as many as 80,000 people are diagnosed with hypoparathyroidism,” stated Thierry Abribat, Ph.D., founder and chief executive officer of Amolyt Pharma. “Despite current treatment options, many patients continue to experience debilitating symptoms due to poorly regulated serum calcium levels and hypercalciuria, a key risk factor for chronic kidney disease, and they are in need of better therapeutic approaches.”
Soraya Allas, M.D., Ph.D., senior vice president of clinical development and regulatory affairs of Amolyt Pharma, added, “Based on data observed to date from our Phase 1 clinical trial in healthy volunteers, we believe AZP-3601 may provide significant clinical benefits, in particular, sustained 24-hour serum calcium and urinary calcium normalization. Bone biomarker data from this trial also leads us to believe that AZP-3601’s targeted mechanism of action may preserve bone integrity. These are important benefits as 26% of patients with hypoparathyroidism have chronic kidney disease and 17% have already developed osteopenia or osteoporosis. We look forward to announcing safety and efficacy data in patients mid-year.”
In October 2021, Amolyt presented positive phase 1 data in healthy volunteers at the American Society for Bone and Mineral Research (ASBMR) 2021 Annual Meeting, which provided strong scientific rationale for continued development.
For more information, please see NCT05239221 on clinicaltrials.gov.