{"id":6780,"date":"2024-03-06T03:07:03","date_gmt":"2024-03-06T03:07:03","guid":{"rendered":"https:\/\/economicherald.net\/?p=6780"},"modified":"2024-03-06T03:07:03","modified_gmt":"2024-03-06T03:07:03","slug":"adaltas-ad-214-extension-study-reaches-milestone-for-phase-ii-clinical-studies-and-partnering","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=6780","title":{"rendered":"AdAlta\u2019s Ad-214 extension study reaches milestone for Phase II clinical studies and partnering"},"content":{"rendered":"<p>Phase I extension study of AD-214 tested the target Phase II dose of AD-214 in healthy volunteers<br \/>\nAdAlta says the findings positively answer key partner questions and support progressing AD-214 Phase II clinical studies in Idiopathic Pulmonary Fibrosis (IPF)<br \/>\nResults now being shared with existing pipeline of potential partners<\/p>\n<p>\u00a0<\/p>\n<p><strong><em>Special Report<\/em>: Key results from a Phase I extension study of AdAlta\u2019s lead asset, AD-214, have positively answered questions being asked by pharma partners, while establishing the tolerability of the planned Phase II dose.<\/strong><\/p>\n<p><a href=\"https:\/\/stockhead.com.au\/company\/adalta-1ad\/\">AdAlta\u2019s (ASX:1AD)<\/a> lead asset, AD-214, is being developed for fibrotic diseases, including the debilitating and fatal disease, Idiopathic Pulmonary Fibrosis (IPF).<\/p>\n<p>The company recently undertook a Phase I extension study of AD-214 to evaluate the safety and tolerability of multiple intravenous (IV) 10 mg\/kg doses in healthy volunteers.<\/p>\n<p>Collecting the data was essential for both progressing to Phase II studies and for partnering. All participants received four doses of AD-214, with the fourth dose 12\u00a0weeks after the third and designed to assess the effect of antidrug antibodies (ADAs), a common response to biologic drugs.<\/p>\n<p>\u00a0<\/p>\n<h2><strong>Top line results <\/strong><\/h2>\n<p>Key findings of the study demonstrated that AD-214 was well tolerated at 10mg\/kg intravenously (IV) every two weeks, while the bioavailability was consistent across all doses.<\/p>\n<p>The pharmacodynamic (PD) activity of AD-214 as measured by transient changes in white blood cell counts was consistent across all doses and with prior single dose studies. Blocking of AD-214\u2019s target receptor was also in line with expectations and supported potential efficacy of this dose.<\/p>\n<p>Antidrug antibodies (ADAs) were detected at low levels in all participants in the study but did not affect AD-214 PK or PD, supporting 1AD\u2019s hypothesis that the low levels of ADAs are unlikely to be of clinical safety or efficacy concern.<\/p>\n<p>\u00a0<\/p>\n<h2><strong>Prepped for Phase II studies <\/strong><\/h2>\n<p>Understanding the ADA profile of AD-214 is a key priority for potential pharmaceutical company partners and with these questions now answered, 1AD believes the molecule is prepped for Phase II clinical studies.<\/p>\n<p>\u201cThis is a significant milestone for AdAlta,\u201d 1AD managing director and CEO Tim Oldham says.<\/p>\n<p>\u201cWe have already commenced the process of sharing these latest results with our potential partners with a view to progressing a licensing or asset financing transaction in the near term.<\/p>\n<p>\u201cSuch a transaction would enable AD-214 to advance to Phase II clinical trials in Idiopathic Pulmonary Fibrosis to provide a new option for patients with this debilitating and fatal disease as well as providing a return on our investment to date.\u201d<\/p>\n<p>Results now being shared with existing pipeline of potential partners with a view to progressing a licensing or asset financing transaction in the near term.<\/p>\n<p>\u00a0<\/p>\n\n<p><span class=\"mce_SELRES_start\">\ufeff<\/span>\u00a0<\/p>\n<p><em>This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing. <\/em><\/p>\n<p><em>\u00a0<\/em><\/p>\n<p><em>This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n<p><span class=\"et_bloom_bottom_trigger\"><\/span><\/p>\n<p>The post <a href=\"https:\/\/stockhead.com.au\/health\/adaltas-ad-214-extension-study-reaches-milestone-for-phase-ii-clinical-studies-and-partnering\/\">AdAlta\u2019s Ad-214 extension study reaches milestone for Phase II clinical studies and partnering<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Phase I extension study of AD-214 tested the target Phase II dose of AD-214 in healthy volunteers AdAlta says the findings positively answer key partner <a href=\"https:\/\/economicherald.net\/?p=6780\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":6781,"comment_status":"","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-6780","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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