LYON, France, and Cambridge, MA, June 5, 2023 - Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced the initiation of a Phase 1 clinical trial of the Company’s peptide growth hormone receptor antagonist (GHRA), AZP-3813, which is being developed as a potential add-on to somatostatin analogs (SSAs) for the treatment of acromegaly.
“Somatostatin analogs currently represent the standard of care first line therapy in the pharmacological management of acromegaly due to their demonstrated ability to reduce IGF-1 levels and control remnant tumor growth. However, despite some reduction in excess growth hormone (GH) secretion, SSAs leave more than 60% of the patients with elevated IGF-1 levels, which over time can lead to a broad range of serious complications,” stated Mark Sumeray, chief medical officer of Amolyt Pharma. “We believe there is strong scientific rationale for combining SSAs with GHRAs to further decrease IGF-1 levels and to antagonize the peripheral effects of GH action. Our intent is therefore to develop AZP-3813 as an add-on to SSAs to improve control of the disease and quality of life for more patients.”
The Phase 1 clinical program will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZP-3813 following single and multiple ascending doses in healthy subjects. Results of the Phase 1 trial are expected in the first quarter of 2024.
“Developing a potential treatment for acromegaly leverages our prior research and work developing therapeutic peptides for rare endocrine disorders, and we are pleased to have initiated this Phase 1 trial for AZP-3813 based on a solid preclinical pharmacology package. Following our recent announcement of the initiation of our Phase 3 trial for eneboparatide, our investigational PTH1 receptor agonist for the treatment of hypoparathyroidism, we are pleased to continue to build our clinical pipeline with AZP-3813” said Thierry Abribat, Ph.D., founder and chief executive officer of Amolyt Pharma.