Lyon, France, and Cambridge, MA, May 2, 2024 — Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced that eneboparatide, its lead therapeutic peptide candidate in Phase 3 development for the treatment of hypoparathyroidism, has been granted fast track designation by the U.S.

法国里昂和马萨诸塞州剑桥，2024年5月2日-专门开发罕见内分泌和相关疾病治疗肽的全球公司Amolyt Pharma今天宣布，其治疗甲状旁腺功能减退症的第三阶段开发中的主要治疗肽候选药物依博帕肽已被美国授予快速通道指定。

Food and Drug Administration (FDA). 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, Ph.D., founder and chief executive officer of Amolyt Pharma.

美国食品和药物管理局（FDA）。FDA的快速通道程序旨在促进新药的开发和加速审查，以治疗医疗需求未得到满足的严重疾病，目的是更快地为患者引入新的治疗方案。Amolyt Pharma创始人兼首席执行官Thierry Abribat博士表示：“我们认为，FDA授予恩博帕肽快速通道标志，反映了该机构认识到甲状旁腺功能减退症患者持续存在的重大未满足需求。”。

“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,” stated Mark Sumeray, M.D., chief medical officer.

“我们期待着与该机构保持建设性对话，尽可能有效地为患有这种罕见但具有挑战性的内分泌疾病的患者带来新的希望。”“目前的护理标准治疗，口服钙和维生素D补充剂很少控制甲状旁腺功能减退的改变生命的症状和并发症，许多患者有肾功能下降和骨质量下降的风险，”首席医学官马克·苏梅雷（Mark Sumeray）表示。

“In studies to date, eneboparatide has been shown to normalize mean serum calcium and mean urinary calcium excretion while restoring balanced bone turnover. Building upon findings from our successful Phase 2 clinical trial, we are working diligently to execute our ongoing Calypso Phase 3 study and look forward to topline data in 2025.”About Eneboparatide Phase 3 Calypso TrialCalypso i.

“在迄今为止的研究中，恩博帕肽已被证明可以使平均血钙和平均尿钙排泄正常化，同时恢复平衡的骨转换。基于我们成功的2期临床试验的结果，我们正在努力执行我们正在进行的Calypso 3期研究，并期待2025年的topline数据。”关于恩博帕肽3期Calypso TrialCalypso i。