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CervoMed Announces Oral Presentation at CTAD 2023 Highlighting Learnings from Phase 2a Which Optimized the Design of the Phase 2b Clinical Study of Neflamapimod in Dementia with Lewy Bodies
With incorporation of key learnings, Phase 2b has >95% (approaching 100%) statistical power to meet its primary endpoint: change in Clinical Dementia Rating
About this update from Cervomed Inc.
[{"type":"text","content":"With incorporation of key learnings, Phase 2b has >95% (approaching 100%) statistical power to meet its primary endpoint: change in Clinical Dementia Rating Sum-of-Boxes (CDR-SB) vs. placebo \nNew data included in the presentation show that in patients without Alzheimer's-related co-pathology, neflamapimod treatment demonstrates significant reduction vs. placebo of a potential blood biomarker of dementia with Lewy bodies\nBOSTON, Oct. 25, 2023 /PRNewswire/ -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for degenerative diseases of the brain, announced an oral presentation today by Dr. Niels Prins, Chief Executive Officer of the Brain Research Center in the Netherlands, at the 16th Clinical Trials in Alzheimer's Disease (CTAD) conference highlighted the neflamapimod clinical development program, including the RewinD-LB Phase 2b study design and the supportive Phase 2a clinical data, for the treatment of patients with dementia with Lewy bodies (DLB).\n\n \n \n \n \n \n \n\n \n\"We are pleased to have had the opportunity at this year's CTAD conference to comprehensively present the findings in Phase 2a and discuss the analyses that went into optimizing the Phase 2b study design for the treatment of patients with DLB,\" said John Alam, MD, Chief Executive Officer of CervoMed. \"Our Phase 2b DLB study, with its optimized design, has substantial statistical power to detect an effect on the Clinical Dementia Rating Sum-of-boxes, and is currently actively enrolling patients in the US, the UK, and the Netherlands. We look forward to completing enrollment during the first half of 2024 and then reporting initial results from the placebo-controlled portion of the study during the second half of 2024.\"\nBased on the learnings, the distinctions from Phase 2a in the RewinD-LB study include, (1) the use of one dosing regimen of neflamapimod (40mg capsules three-times-a-day, TID), based on the dose-response analysis of the study, and on observations in AD studies; (2) the choice of Clinical Dementia Rating Sum of Boxes (CDR-SB) as the primary endpoint; and (3) the exclusion of patients with Alzheimer's related co-pathology, as evaluated by plasma levels of tau phosphorylated at position 181 (ptau181; to enrich for such patients, the global CDR score at entry will be limited to 0.5 or 1.0). With these ...