Amolyt Pharma, a global company specialising in the development of therapeutic peptides for rare endocrine and related diseases, has been awarded FDA fast track designation for eneboparatide, its lead therapeutic peptide candidate in Phase III development for the treatment of hypoparathyroidism.
The FDA’s Fast Track process is designed to facilitate the development and expedite the review of new drugs to treat serious conditions with unmet medical needs, with the goal of introducing new treatment options to patients faster.
Eneboparatide has been shown to normalise mean serum calcium and mean urinary calcium excretion while restoring balanced bone turnover
“The current standard of care treatment — oral calcium and vitamin D supplementation — seldom controls the life altering symptoms and complications of hypoparathyroidism, with many patients at risk of declining kidney function and diminished bone quality,” stated Mark Sumeray, Chief Medical Officer of Amolyt Pharma. “In studies to date, eneboparatide has been shown to normalise mean serum calcium and mean urinary calcium excretion while restoring balanced bone turnover. Building upon findings from our successful Phase II clinical trial, we are working diligently to execute our ongoing Calypso Phase III study and look forward to topline data in 2025.”
The Phase III Calypso trial
Calypso is a Phase III multi centre, randomised, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of eneboparatide in patients with chronic hypoparathyroidism.
Approximately 165 patients treated with standard of care will be randomised in a 2:1 ratio to receive eneboparatide or placebo. The primary efficacy endpoint is the proportion of patients that achieve albumin-adjusted serum calcium within the normal range and independence from standard of care after 24 weeks of treatment.
The key secondary efficacy endpoints include normalisation of 24-hour urinary calcium in patients with hypercalciuria at baseline and assessment of patient-reported outcomes that reflect symptoms associated with physical and cognitive function and impact on quality of life.
Additional exploratory endpoints assess bone quantity and quality using DXA scanning and high resolution peripheral quantitative CT scanning. After the initial 24-week placebo-controlled period, all patients will be treated with eneboparatide in an open-label extension phase for an additional 28 weeks.
The Calypso trial is being conducted in more than 50 centers in the US, Europe, Canada, and the UK.