Amolyt Pharma has been granted Fast Track designation by the FDA for eneboparatide, its therapeutic peptide candidate in phase 3 development for treating hypoparathyroidism.
The drug was a driving force behind AstraZeneca's acquisition of Amolyt back in March. The deal, which went through AstraZeneca's Rare Disease unit, Alexion, was valued at up to $1.05 billion including $800 million upfront and $250 million based on regulatory milestones.
Hypoparathyroidism is characterized by a deficiency of parathyroid hormone that results in decreased calcium and elevated phosphorus levels in the blood. The condition primarily affects women, particularly those who are post-menopausal and at increased risk for osteoporosis. Despite available treatments, patients often experience persistent symptoms that impact their quality of life, and complications including kidney disease.
Eneboparatide aims to treat hypoparathyroidism by producing sustained and stable calcium levels in the blood and reducing urinary calcium excretion, potentially preventing the progression of kidney disease and deterioration in bone quality.
Eneboparatide is currently being studied in Amolyt’s Calypso trial, a phase 3 multicenter, randomized, placebo-controlled, double-blind study evaluating efficacy and safety of eneboparatide in patients with chronic hypoparathyroidism. The trial design includes a 24-week placebo-controlled phase followed by a 28-week open-label extension phase.