{"id":27456,"date":"2025-02-20T17:40:22","date_gmt":"2025-02-20T09:40:22","guid":{"rendered":"https:\/\/flcube.com\/?p=27456"},"modified":"2025-02-20T17:40:24","modified_gmt":"2025-02-20T09:40:24","slug":"bayers-askbio-receives-rmat-designation-for-ab-1005-in-parkinsons-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=27456","title":{"rendered":"Bayer’s AskBio Receives RMAT Designation for AB-1005 in Parkinson’s Disease"},"content":{"rendered":"\n

German pharmaceutical giant Bayer (ETR: BAYN<\/a>) announced that its gene therapy subsidiary AskBio Inc. has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational gene therapy AB-1005 as a treatment for Parkinson’s disease (PD).<\/p>\n\n\n\n

Drug Profile<\/strong>
AB-1005 is an investigational gene therapy based on an adeno-associated viral vector serotype 2 (AAV2) containing the human glial cell line-derived neurotrophic factor (GDNF) transgene. The therapy allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with MRI-monitored convection enhanced delivery.<\/p>\n\n\n\n

Clinical Trial Results<\/strong>
Data from the open-label, non-controlled Phase Ib study showed that AB-1005 was well tolerated, with no treatment-related serious adverse events observed. In the moderate PD cohort, patients showed trends for improvement or stability on several PD-relevant clinical scales at 36 months compared to baseline, including the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and self-reported PD motor diaries. There were also trends in reductions in Parkinson’s medications (levodopa-equivalent daily dose [LEDD]). Most participants in the mild PD cohort showed an overall stable clinical status with little change in MDS-UPDRS, the self-reported PD motor diary, or LEDD.<\/p>\n\n\n\n

Ongoing Phase II Study<\/strong>
The Phase II REGENERATE-PD study for AB-1005 is currently enrolling patients in the US.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

German pharmaceutical giant Bayer (ETR: BAYN) announced that its gene therapy subsidiary AskBio Inc. has…<\/p>\n","protected":false},"author":1,"featured_media":27458,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[3725,269,967,66],"class_list":["post-27456","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-askbio","tag-bayer","tag-etr-bayn","tag-gene-therapy"],"yoast_head":"\nBayer's AskBio Receives RMAT Designation for AB-1005 in Parkinson's Disease - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"German pharmaceutical giant Bayer (ETR: BAYN) announced that its gene therapy subsidiary AskBio Inc. has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational gene therapy AB-1005 as a treatment for Parkinson's disease (PD).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=27456\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bayer's AskBio Receives RMAT Designation for AB-1005 in Parkinson's Disease\" \/>\n<meta property=\"og:description\" content=\"German pharmaceutical giant Bayer (ETR: BAYN) announced that its gene therapy subsidiary AskBio Inc. has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational gene therapy AB-1005 as a treatment for Parkinson's disease (PD).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=27456\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-20T09:40:22+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-20T09:40:24+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/2016-png.avif\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"530\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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