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AC Immune Reports Top Line Results from TAURIEL Phase 2 Trial Evaluating Semorinemab in Early Alzheimer’s Disease | ![]() |
Wednesday, 23. September 2020 13:00 | ||||
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Genentech disclosed that the anti-Tau antibody did not meet the co-primary efficacy endpoint or two secondary endpoints in the TAURIEL study; the primary safety endpoint was met Multiple other clinical stage programs progressing as planned Investigational new drug (IND) enabling studies ongoing for first-in-class therapeutic candidates targeting TDP-43 and alpha-synuclein Discovery on novel neuroinflammation target NLRP3-ASC inflammasome, including antibody and small molecule MorphomerTM inhibitors, advancing AC Immune remains in a strong financial position with operations fully financed through Q1 2024 LAUSANNE, Switzerland,, Sept. 23, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that Genentech, a member of the Roche Group, has informed the Company of top line results from a Phase 2 trial of the anti-Tau antibody, semorinemab, in early (prodromal to mild) Alzheimer’s disease (AD) which show that semorinemab did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo. Two secondary endpoints, Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimer’s Disease Cooperative Study Group – Activities of Daily Living Inventory (ADCS-ADL) were also not met. Additional data analyses are ongoing and Genentech plans to present the results from TAURIEL at an upcoming medical congress. The second Phase 2 (LAURIET) study of semorinemab in patients with moderate AD remains ongoing. Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “Today’s news is surprising and disappointing, given what we as a field know about Tau and its strong spatiotemporal correlation with both symptoms and pathology in AD. We believe the full data analysis of this first-of-its-kind study will yield information about this promising target that will advance our understanding and inform future efforts to successfully develop effective therapeutics for neurodegenerative diseases (NDD). We would like to thank the patients, caregivers and investigators who participated in this important, ground-breaking trial and look forward to the final results from our partner, Genentech.” Prof. Pfeifer continued, “Our proprietary technology platforms and proven business model of discovery, early development and partnering high-risk therapeutic candidates for AD have successfully generated CHF 334 million in non-dilutive funding and enabled us to accelerate clinical development of our product candidates in collaboration with world-leading partners. This strategy enables us to focus our resources on advancing the next generation of first-in-class or best-in-class assets. With current funding through Q1 2024, this robust risk-and-financial-sharing strategy will continue unaffected as we work diligently to mature our proprietary candidates and generate substantial future value for the Company.” “One of AC Immune’s key strengths is our diversified approach and our broad pipeline of assets, fueled by our remarkably efficient SupraAntigen™ and Morphomer™ platforms and staff. This is evidenced by our novel therapeutic candidates targeting TDP-43 and alpha-synuclein, which have advanced rapidly from discovery into IND-enabling studies. Furthermore, we are particularly pleased with progress in our recently disclosed discovery program targeting the NLRP3-ASC inflammasome,” Prof. Pfeifer added. Both TDP-43 and alpha-synuclein are major pathologies in NDD and are increasingly thought to be important co-pathologies in AD. AC Immune’s programs directed towards these targets are the most advanced and comprehensive in the field. AC Immune’s alpha-synuclein positron emission tomography (PET) tracer program for Parkinson’s disease (PD) diagnostics was recently recognized by the Michael J. Fox Foundation (MJFF) award. Activation of the NLRP3-ASC inflammasome leads to chronic and uncontrolled inflammation, which is understood to drive a number of neurodegenerative and inflammatory diseases. AC Immune’s approach has high potential for effective therapies, in NDD and non-NDD as mono- and/or combination therapy. Broad Pipeline and Upcoming Milestones in 2020
Details of the TAURIEL study About AC Immune SA For further information, please contact:
Forward looking statements Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/13290144-c3a0-4e65-b079-eb5cc2484149 https://www.globenewswire.com/NewsRoom/AttachmentNg/bc21e9b8-1152-488a-b719-cb667d4cf9ab |
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