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CervoMed Announces Completion of Enrollment in Phase 2b RewinD-LB Clinical Trial of Neflamapimod for the Treatment of Patients with Dementia with Lewy Bodies
- Topline data expected in December 2024 - - Phase 2b design optimized for success; clear path to market in this high value indication expected with positive
About this update from Cervomed Inc.
[{"type":"text","content":"- Topline data expected in December 2024 - - Phase 2b design optimized for success; clear path to market in this high value indication expected with positive result - BOSTON, June 11, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced that it has completed enrollment in RewinD-LB, a Phase 2b trial evaluating neflamapimod in patients with dementia with Lewy bodies (DLB). “Drug development for the major dementias over the past decade has progressively focused on earlier stages of disease. In our phase 2a data with neflamapimod in patients with DLB, the treatment response in patients with pure DLB was substantial and greater than the response seen in patients who had biomarker evidence of Alzheimer’s disease (AD)-related co-pathology, the latter representing patients with more advanced disease,” said John Alam, MD, Chief Executive Officer of CervoMed. “The completion of enrollment demonstrates, for the first time, the feasibility of enrolling a pure DLB patient population into an adequately powered trial. The expeditious nature of the enrollment reflects the level of engagement across our clinical trial sites and the execution of our clinical team and partners, as well as the finding that most patients who entered into screening did not have AD-related co-pathology, as measured by plasma ptau181 testing. We expect to report topline data in December 2024, which we believe will bring us one step closer to potentially delivering the first DLB specific FDA-approved therapy.” Kelly Blackburn, CervoMed’s SVP of Clinical Development, added, “Completing enrollment in the RewinD-LB trial marks a significant milestone and I would like to congratulate the CervoMed team and our partners, and most importantly, thank the patients and their families for participating in the neflamapimod clinical development program. The rapid pace of enrollment once all sites were activated points to the high unmet medical need and patient interest in novel treatments for DLB.” Eligibility criteria to be randomized included: (1) a diagnosis of DLB by consensus criteria, (2) Clinical Dementia Rating Global Score (CDR-GS) of 0.5 or 1.0, and (3) absence of AD co-pathology, as evidenced by plasma phosphorylated tau at position 181 (ptau181) of less than...