NEW YORK, April 21, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman ...

Core Insights - Lecanemab has received Marketing Authorization in the EU, marking it as the first therapy targeting the underlying cause of Alzheimer's disease to be approved in this region [1][2] - The treatment is specifically indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer's disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology [1][2] - The approval applies to all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway [1][3] Company Overview - Eisai Co., Ltd. and Biogen Inc. are collaborating on the development and commercialization of lecanemab, with Eisai leading the global development and regulatory submissions [2][8] - The approval of lecanemab in the EU is the thirteenth approval globally, following its benefits to thousands of patients in the U.S., Japan, and other regions [2][6] - Eisai aims to work with national reimbursement authorities and healthcare providers to ensure access to lecanemab for eligible patients as soon as possible [2] Clinical Data - The authorization was based on Phase 3 data from the Clarity AD clinical trial, which involved 1,795 patients with early Alzheimer's disease [4][6] - In the trial, lecanemab reduced clinical decline on the CDR-SB scale by 31% at 18 months compared to placebo [4][6] - The secondary endpoint showed a 33% less decline in daily living activities for patients treated with lecanemab compared to placebo [4][6] Market Context - Alzheimer's disease currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with mild dementia in Europe, indicating a significant unmet need for effective treatments [1][6] - Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils, which are key contributors to neuronal injury in Alzheimer's disease [1][4] - The approval of lecanemab represents a landmark advancement in a field that has seen little innovation over the past two decades [2][6]

Core Insights - Roche Holdings AG presented new data on trontinemab at the AD/PD 2025 International Conference, highlighting its potential in Alzheimer's disease treatment and the Elecsys pTau181 plasma test's ability to rule out amyloid pathology [1][4]. Group 1: Trontinemab Study Results - The ongoing Phase 1b/2a Brainshuttle AD study of trontinemab showed dose-dependent rapid amyloid depletion from the brain [1]. - Preliminary results indicated that trontinemab reduced amyloid levels below the 24 centiloid threshold in 81% of participants (21 out of 26) in the 3.6 mg/kg dose group after 28 weeks [6]. - The study reported a favorable safety profile, with amyloid-related imaging abnormalities (ARIA-E) observed in less than 5% of participants, and only one case associated with mild symptoms [3]. Group 2: Elecsys pTau181 Plasma Test - Results from a multicenter study involving 604 participants demonstrated the Elecsys pTau181 plasma test's potential to accurately rule out amyloid pathology in individuals with cognitive impairment [4]. - Roche anticipates that the Elecsys pTau181 test will be available in Europe by late 2025, followed by the U.S. [4]. Group 3: Future Developments - Roche plans to initiate a Phase 3 program for trontinemab later this year [4]. - The company continues to reinforce its commitment to advancing research in Alzheimer's disease through ongoing studies and new testing methods [4]. Group 4: Market Reaction - Following the presentation of the new data, Roche's stock (RHHBY) closed lower by 4.37% to $37.65 [5].

InMed Pharmaceuticals (INM) Update / Briefing November 12, 2024 02:00 PM ET Speaker0 Hello, everyone. Thank you for attending today's Fierce Biotech webinar, Alzheimer's Outlook, The Next Step. I understand we have a great number of attendees on today's webinar, and I want to thank InMed Pharmaceuticals for sponsoring this presentation. My name is Phyllis Fearle, and I will be moderating today's conversation. But before we get started, here's a few quick housekeeping notes. You can access closed captions fr ...