{"id":12033,"date":"2024-07-09T02:10:43","date_gmt":"2024-07-09T02:10:43","guid":{"rendered":"https:\/\/economicherald.net\/?p=12033"},"modified":"2024-07-09T02:10:43","modified_gmt":"2024-07-09T02:10:43","slug":"neurotech-chasing-prized-us-orphan-drug-designation","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=12033","title":{"rendered":"Neurotech chasing prized US orphan drug designation"},"content":{"rendered":"<p>Neurotech files for orphan drug designation for oral cannabinoid drug NTI164<br \/>\nSubmission focused on rare paediatric disease<br \/>\nFDA expected to respond within three months<\/p>\n<p>\u00a0<\/p>\n<p><strong><em>Special Report:<\/em> Paediatric biopharmaceutical company Neurotech has filed for orphan drug designation (ODD) with the US Food and Drug Administration.<\/strong><\/p>\n<p>The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition.<\/p>\n<p>ODD qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees and a potential seven years of market exclusivity after approval.<\/p>\n<p><a href=\"https:\/\/stockhead.com.au\/company\/neurotech-nti\/\" target=\"_blank\" rel=\"noopener\"><strong>Neurotech (ASX:NTI)<\/strong><\/a> is seeking the designation for the use of its NTI164 treatment in children and adults diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS).<\/p>\n<p>A response from the FDA Office of Orphan Products Development is anticipated within three months of filing.<\/p>\n<p>\u00a0<\/p>\n<h2><strong>A rare neurological disorder<\/strong><\/h2>\n<p>The Orphan Drug Act defines a rare disease as a disease or condition that affects less than 200,000 people in the United States.<\/p>\n<p>PANDAS\/PANS is a rare neurological disorder predominately in children characterised by an infection triggered autoimmune response and associated neuroinflammation which results in a sudden, dramatic change in personality, displayed as obsessive-compulsive disorder (OCD), anxiety, tics or other abnormal movements and personality changes.<\/p>\n<p>There are no approved therapies for PANDAS\/PANS, globally \u2013 and the company estimates the annual market for the disorder is worth US$1.2 billion.<\/p>\n<p>\u00a0<\/p>\n<h2><strong>Promising clinical trials<\/strong><\/h2>\n<p>Neurotech\u2019s broad-spectrum oral cannabinoid drug therapy called NTI164 has already completed a Phase II\/III randomised, double-blind, placebo-controlled clinical trial in Autism Spectrum Disorder (ASD).<\/p>\n<p>Clinically meaningful and statistically significant benefits were reported across a number of clinically validated measures and excellent safety, the company says.<\/p>\n<p>In addition, Neurotech has completed and reported statistically significant and clinically meaningful Phase I\/II trials in ASD and PANDAS and PANS, along with Rett Syndrome. And Neurotech has received human ethics committee clearance for a Phase I\/II clinical trial in spastic cerebral palsy.<\/p>\n<p>\u00a0<\/p>\n<p><em>This article was developed in collaboration with Neurotech, a Stockhead advertiser at the time of publishing. <\/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>The post <a href=\"https:\/\/stockhead.com.au\/health\/neurotech-chasing-prized-us-orphan-drug-designation\/\">Neurotech chasing prized US orphan drug designation<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Neurotech files for orphan drug designation for oral cannabinoid drug NTI164 Submission focused on rare paediatric disease FDA expected to respond within three months \u00a0 <a href=\"https:\/\/economicherald.net\/?p=12033\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":12034,"comment_status":"","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-12033","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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