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BOSTON - CervoMed Inc. (NASDAQ:CRVO), a clinical-stage biotech company with a market capitalization of $78 million, announced Monday that its experimental drug neflamapimod demonstrated a 54% reduction in risk of clinically significant worsening in patients with dementia with Lewy bodies (DLB) after 32 weeks of treatment. The company’s stock has shown remarkable momentum, surging nearly 300% over the past six months, according to InvestingPro data.
The data, presented at the Alzheimer’s Association International Congress 2025, showed that the risk reduction improved to 64% among patients with minimal evidence of Alzheimer’s disease co-pathology, according to the company’s press release. InvestingPro analysis reveals the company maintains a strong financial position with a current ratio of 9.78, indicating robust liquidity to support its clinical development programs.
The Phase 2b RewinD-LB trial measured disease progression using the Clinical Dementia Rating Sum of Boxes (CDR-SB), a standard assessment tool in dementia studies. Researchers defined clinically meaningful progression as an increase of 1.5 points or more on this scale.
The trial also showed that patients treated with neflamapimod experienced a significant reduction in plasma levels of glial fibrillary acidic protein (GFAP), a marker associated with neurodegeneration.
"Reducing the risk of a 1.5-point worsening over 32 weeks on the CDR-SB by more than 50% would likely represent a clinically meaningful slowing of clinical progression," said Lawrence S. Honig, Professor of Neurology at Columbia University Irving Medical Center, who presented the results.
The study revealed that newer batches of neflamapimod capsules, which achieved targeted plasma concentrations, showed better results than older batches with lower plasma exposures.
CervoMed plans to meet with the U.S. Food and Drug Administration in the fourth quarter of 2025 to discuss the design of a potential Phase 3 trial.
DLB is considered the second most common form of dementia, affecting both movement and cognition. Currently, there are limited effective treatment options for the condition.
The company reported that both older and newer capsule formulations demonstrated comparable safety profiles with no new safety concerns identified during the extension phase of the trial.
In other recent news, CervoMed Inc. is preparing to announce the results of the 32-week extension phase for its Phase 2b RewinD-LB study of neflamapimod, a treatment for dementia with Lewy bodies (DLB). This announcement will take place during a conference call scheduled for Monday. Previously, CervoMed faced challenges when neflamapimod did not meet the primary or secondary endpoints in the initial study phase, but subsequent findings from an Open-Label Extension phase suggested the earlier negative results were due to expired capsules rather than the drug’s efficacy. Additionally, Chardan Capital Markets has maintained its Buy rating for CervoMed, with a price target of $15.00, following the company’s recent financial disclosures. CervoMed reported $35.2 million in cash, cash equivalents, and marketable securities, a financial position expected to support operations into mid-2026, aided by pending grant funds from the National Institute on Aging. These developments highlight CervoMed’s ongoing efforts in advancing treatments for age-related neurological disorders.
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