FDA Fast Tracks Amolyt's Hypoparathyroidism Drug

Amolyt Pharma has received Fast Track designation from the FDA for its therapeutic peptide candidate eneboparatide, which is currently in phase 3 development for the treatment of hypoparathyroidism. This development was a key factor in AstraZeneca's decision to acquire Amolyt in March. The acquisition, conducted through AstraZeneca's Rare Disease unit, Alexion, was valued at up to $1.05 billion, including $800 million upfront and $250 million contingent on regulatory milestones.

Hypoparathyroidism is a condition marked by inadequate production of parathyroid hormone, leading to reduced calcium and increased phosphorus levels in the bloodstream. This disorder predominantly affects women, especially those who are post-menopausal and at heightened risk for osteoporosis. Despite existing treatments, many patients continue to suffer from symptoms that degrade their quality of life and face complications such as kidney disease.

Eneboparatide is designed to manage hypoparathyroidism by ensuring stable and sustained calcium levels in the blood and decreasing urinary calcium excretion. These effects could potentially prevent the worsening of kidney disease and deterioration in bone quality.

Currently, eneboparatide is being evaluated in Amolyt’s Calypso trial. This is a phase 3 multicenter, randomized, placebo-controlled, double-blind study aimed at assessing the efficacy and safety of eneboparatide in individuals with chronic hypoparathyroidism. The trial consists of a 24-week placebo-controlled phase followed by a 28-week open-label extension phase.