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CervoMed Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Updates

In This Article:

CervoMed Inc.
CervoMed Inc.

-Reported positive 16-week results from the extension phase of the Phase 2b RewinD-LB trial of neflamapimod in dementia with Lewy bodies (DLB), including improvement on the trial’s primary outcome measure-

-Plan to initiate Phase 3 trial in mid-2026 following meeting with regulatory authorities-

-Awarded 2024 Prix Galien USA Award as “Best Startup” by the Galien Foundation-

BOSTON, March 17, 2025 (GLOBE NEWSWIRE) --  CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results for the fourth quarter and full year ended December 31, 2024.

“Following the highly encouraging 16-week extension results from our Phase 2b RewinD-LB trial, we believe we have established proof-of-concept for neflamapimod as a potential treatment for DLB. Our team is now focused on reporting the results from the 32-week extension phase in the second half of 2025 and discussing next steps on Phase 3 trial design with regulatory authorities,” said John Alam, MD, Chief Executive Officer of CervoMed.

Recent Highlights and Anticipated Milestones

  • The 16-week results from the extension phase of the Phase 2b RewinD-LB trial have been accepted as an oral presentation at the 19th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders (AD/PD™) in Vienna, Austria, April 1-5, 2025.

  • In March 2025, CervoMed reported positive 16-week results from the extension phase of the RewinD-LB trial in which patients who were administered a new batch of neflamapimod capsules had higher plasma drug concentration levels and demonstrated improvements on the primary outcome measure, Clinical Dementia Rating Sum of Boxes (p<0.001 v. old capsules; p=0.003 v. placebo), and a key secondary endpoint. The full details on these results can be found here.

    • The Company expects to report 32-week results from the extension phase of the RewinD-LB trial in the second half of 2025.

    • Initial safety, biomarker and pharmacokinetic data from an ongoing trial in patients with mild-to-moderate DLB being treated with a twice daily regimen (80mg BID) of neflamapimod is expected to be available in the fourth quarter of 2025.

  • In January 2025, the Company presented at the 8th International Lewy Body Dementia Conference (ILBDC) in Amsterdam, the Netherlands.

  • During 2025, CervoMed plans to also advance neflamapimod development in additional diseases:

    • In November 2024, the U.S. Food and Drug Administration (FDA) granted neflamapimod Orphan Drug designation for the treatment of frontotemporal dementia (FTD) and CervoMed plans to initiate a Phase 2a trial evaluating neflamapimod in the nonfluent/agrammatic variant of primary progressive aphasia – a subtype of FTD – in mid-2025.

    • In the second quarter of 2025, CervoMed plans to initiate the Phase 2 Restore Trial to evaluate neflamapimod in patients recovering from ischemic stroke.

  • Fourth Quarter 2024 Highlights:

    • CervoMed added to its leadership team with the appointments of Claudia Ordonez, MD, as Senior Vice President, Medical Science, and Mark De Rosch, Ph.D., FRAPS, as Senior Vice President, Regulatory and Government Affairs and Program Management.

    • CervoMed was awarded the 2024 Prix Galien USA 2024 prize in the “Best Startup” category by the Galien Foundation, a premier global institution dedicated to honoring innovators in life sciences.

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