FDA fast tracks Amolyt’s hypoparathyroidism therapy  

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Amolyt Pharma has announced that its lead therapeutic peptide candidate, eneboparatide, has been granted fast track designation by the U.S. Food and Drug Administration (FDA). 

The company’s lead therapeutic peptide candidate is currently in a Phase III clinical trial for the treatment of hypoparathyroidism. 

Hypoparathyroidism is a rare condition defined by a deficiency of parathyroid hormone (PTH) that results in decreased calcium and elevated phosphorus levels in the blood. Approximately 80% of the estimated 80,000 people in the US and 110,000 in the European Union with hypoparathyroidism are women. 

Eneboparatide is an investigational therapeutic peptide designed to bind with high affinity to a specific conformation of the parathyroid hormone (PTH) receptor to produce sustained and stable levels of calcium in the blood and thereby manage the symptoms of hypoparathyroidism. The therpay also limits urine calcium excretion by restoring calcium reabsorption by the kidney and could help prevent progressive decline in kidney function and the development of chronic kidney disease.  

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. 

“We believe FDA’s granting of fast track designation to eneboparatide reflects the agency’s recognition of the significant unmet needs that persist among patients suffering from hypoparathyroidism,” stated Thierry Abribat, Founder and Chief Executive Officer of Amolyt Pharma. “We look forward to maintaining a constructive dialog with the agency as we work to bring new hope to patients suffering from this rare but challenging endocrine disorder as efficiently as possible.” 

“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,” added Mark Sumeray, M.D., Chief Medical Officer. “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 II2 clinical trial, we are working diligently to execute our ongoing Calypso Phase III3 study and look forward to topline data in 2025.” 

 

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