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CervoMed Provides Update on Neflamapimod DLB Program as Part of Presentation at the 8th International Lewy Body Dementia Conference
— Data from the first 16 weeks of the open-label extension phase of the RewinD-LB trial are expected in 1Q 2025 and will include data from participants who
About this update from Cervomed Inc.
[{"type":"text","content":"— Data from the first 16 weeks of the open-label extension phase of the RewinD-LB trial are expected in 1Q 2025 and will include data from participants who have received capsules from a more recently manufactured batch of neflamapimod — — Pharmacokinetic data obtained in a food-effect study in healthy volunteers in 4Q 2024 indicates that the new capsules achieved targeted mean plasma concentrations — — Within-subject comparison of certain participants who received older capsules during the double-blind phase of the RewinD-LB trial and new capsules in the open-label extension phase indicated that participants receiving newer batch capsules, on average, achieved targeted plasma concentrations — BOSTON, Jan. 31, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO) (“CervoMed” or the “Company”), a clinical-stage company focused on developing treatments for age-related neurologic disorders, today provided an update on its neflamapimod development program in dementia with Lewy bodies (DLB) as part of an oral presentation at the 8th International Lewy Body Dementia Conference (ILBDC) of the topline results for the blinded portion of the Company’s Phase 2b RewinD-LB trial. Key Findings from RewinD-LB Trial (Blinded 16-Week Portion) No discernible differences between neflamapimod 40mg dosed three times daily (TID) and placebo treatment groups during the 16-week double-blind phase of the clinical study.Measured trough plasma drug concentrations during the double-blind phase were, on average, similar to those seen with 40mg twice-daily (BID) dosing in a previous study in Alzheimer’s Disease, a potential explanation for the current results.Retrospective analysis of the capsules suggests the lower–than-expected bioavailability may be related primarily to the age of the drug batch utilized during the double-blind phase of the study.The Company believes there is potential to obtain efficacy endpoint data at the targeted plasma drug concentrations during the open-label extension (OLE) phase of the study, during which a portion of participants received capsules from a more recently manufactured drug batch.Pharmacokinetic (PK) findings from a food effect study in healthy volunteers conducted in 4Q 2024 with the newer capsules and within-subject comparison of 13 participants during the OLE phase each indicate that, on average, participants achiev...