{"id":409334,"date":"2021-01-06T08:03:18","date_gmt":"2021-01-06T13:03:18","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=409334"},"modified":"2021-01-06T08:03:18","modified_gmt":"2021-01-06T13:03:18","slug":"amolyt-pharma-receives-orphan-drug-designation-for-azp-3601-for-the-potential-treatment-of-hypoparathyroidism","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/amolyt-pharma-receives-orphan-drug-designation-for-azp-3601-for-the-potential-treatment-of-hypoparathyroidism\/","title":{"rendered":"Amolyt Pharma Receives Orphan Drug Designation for AZP-3601 for the Potential Treatment of Hypoparathyroidism"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">LYON, France and CAMBRIDGE, Mass., Jan.  06, 2021  (GLOBE NEWSWIRE) &#8212; Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug Designation (ODD) to AZP-3601, the company\u2019s clinical candidate for the treatment of hypoparathyroidism.<\/p>\n<p align=\"justify\">\u201cWe believe the FDA\u2019s granting of Orphan Drug Designation to AZP-3601 reflects the agency\u2019s recognition that new and more effective treatment options are needed for this serious endocrine disorder,\u201d stated Thierry Abribat, Ph.D., chief executive officer of Amolyt Pharma. \u201cWe are pleased to have recently dosed the first subject in our Phase 1 clinical trial, and we are committed to executing an efficient development program to diligently bring this promising therapeutic to patients.\u201d\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\n<p align=\"justify\">Orphan drug status is intended to advance drug development for rare diseases. The FDA grants ODD to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of diseases or disorders that affect fewer than 200,000 people in the U.S. ODD provides certain incentives, such as tax credits toward the cost of clinical trials and prescription drug user fee waivers. If a product holding ODD receives the first FDA approval for the disease in which it has such designation, the product is entitled to seven years of market exclusivity, which is independent from intellectual property protection.<\/p>\n<p align=\"justify\">\n        <strong>About AZP-3601<br \/><\/strong>AZP-3601 is a therapeutic peptide designed to target a specific configuration of the parathyroid hormone (PTH) receptor in order to safely produce sustained levels of calcium in the blood and thereby manage the symptoms of hypoparathyroidism. The selective action of AZP-3601 through this distinct configuration of the PTH receptor is also intended to limit urine calcium excretion by stimulating calcium reabsorption by the kidney, consequently preventing chronic kidney disease. In addition, the unique receptor profile and short half-life of AZP-3601 are expected to preserve bone integrity, an important benefit since the majority of patients with hypoparathyroidism are middle-aged women often at increased risk of osteoporosis.<\/p>\n<p align=\"justify\">\n        <strong>About Amolyt Pharma\u00a0<br \/><\/strong>Amolyt Pharma is building on its team\u2019s established expertise in therapeutic peptides to deliver life-changing treatments to patients suffering from rare endocrine and metabolic diseases. Its portfolio includes AZP-3601 as a potential treatment of hypoparathyroidism, AZP-3404, which is undergoing indication prioritization work, and AZP-38XX, a small peptide series under evaluation to select a development candidate for the treatment of acromegaly. Amolyt Pharma aims to further expand and develop its portfolio by leveraging its global network in the field of endocrinology and with support from a strong syndicate of international investors. To learn more, visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=pBrUT3Ck8k0hCd2_V7u9HgndzpinbW9AL90X2Eavq1MPxMlAnlK3zm1NZZ0KTTyyagAPjc8QlkpB-hw3Xig6f_BnqCl0SW5wTve3bxmHXh0=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.amolytpharma.com<\/a>\u00a0or follow us on Twitter at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=J-XtGVHVoGxuOapuZ_ngYjCVf6umYOMW3TgrbiespykUL38OSQ3pIvowtF-IwPf6Qr57YCiJPFbijlfJcAKRz9ngAoXZetEDDKh7PSe8fWI=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">@AmolytPharma<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>At Amolyt:<\/strong>\n      <\/p>\n<p align=\"justify\">\n        <strong>Media: <\/strong><br \/>\n        <br \/>Cherilyn Cecchini, M.D. <br \/>LifeSci Communications <br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=AUTJE-ZiGefYOvzKc4sSe-el4PbEPCKtZE7LhSChsQP7IXqL-AXmn3zYIwCpfeevvc2DoFDi5SVjHnJdqUXxOSU0w2jVnd7MA0GLGrU_6KPYZuKU2JmBge6kw3bg5SI-\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">ccecchini@lifescicomms.com<\/a><br \/>+1.646.876.5196<\/p>\n<p align=\"justify\">\n        <strong>Investors:<\/strong><br \/>\n        <br \/>Ashley Robinson<br \/>LifeSci Advisors, LLC<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=rc9kWjQvOHDion7flTeeDXQFS_M7lbp_rUTK6RhVea2Sma28GJSLQiMEso6fx-q3Uxa7p6i5N65sNpYvM07xEyDKIkR93VshOdIOUQcRvmM=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">arr@lifesciadvisors.com<\/a><br \/>+1.617.430.7577<\/p>\n<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyMTA1NSMzOTA1NTg2IzUwMDA3MjA2NA==\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/0ad49acb-51e4-439d-bfd9-9a3807fd4f5e\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>LYON, France and CAMBRIDGE, Mass., Jan. 06, 2021 (GLOBE NEWSWIRE) &#8212; Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug Designation (ODD) to AZP-3601, the company\u2019s clinical candidate for the treatment of hypoparathyroidism. \u201cWe believe the FDA\u2019s granting of Orphan Drug Designation to AZP-3601 reflects the agency\u2019s recognition that new and more effective treatment options are needed for this serious endocrine disorder,\u201d stated Thierry Abribat, Ph.D., chief executive officer of Amolyt Pharma. \u201cWe are pleased to have recently dosed the first subject in our Phase 1 clinical trial, and we are committed to executing an efficient development program to &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/amolyt-pharma-receives-orphan-drug-designation-for-azp-3601-for-the-potential-treatment-of-hypoparathyroidism\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Amolyt Pharma Receives Orphan Drug Designation for AZP-3601 for the Potential Treatment of Hypoparathyroidism&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-409334","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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