Phase 2b trial showed significant improvements on primary and key secondary outcomes measures, most prominently in patients without AD co-pathology Significant reduction in key neurodegeneration biomarker correlated with treatment response, suggesting neflamapimod may act on underlying disease CervoMed preparing to initiate Phase 3 registrational trial in patients with DLB in the second half of 2026 BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Today in a late-breaking oral session at the 18th Clinical Trials ...

Core Insights - CervoMed Inc. presented data from the Phase 2b RewinD-LB trial at the CTAD Conference, showing that neflamapimod treatment significantly reduced plasma GFAP levels and increased the A42/40 ratio, indicating potential therapeutic effects in dementia with Lewy bodies (DLB) [1][2][3] Company Overview - CervoMed is a clinical-stage biotechnology company focused on developing treatments for age-related brain disorders, with neflamapimod as its lead candidate targeting neuroinflammation and neurodegeneration [9][10] Clinical Trial Details - The RewinD-LB Phase 2b study included a randomized phase comparing neflamapimod to placebo, followed by an open-label extension phase, with a total of 159 participants [7][5] - The trial was funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging [7] Biomarker Findings - The reduction in plasma GFAP levels during the extension phase was significant, with a median change of -16.0 pg/mL, and a correlation was found between GFAP reduction and clinical improvement as measured by CDR-SB [11] - The A42/40 ratio also significantly increased during treatment, suggesting a positive effect on neuroinflammation and amyloidogenesis [11] Disease Context - DLB is the second most common progressive dementia after Alzheimer's disease, affecting millions globally, with no approved treatments available in the U.S. or EU [8][3] - The disease progresses more rapidly than Alzheimer's, with an average time from diagnosis to nursing home care being two years [3] Future Directions - CervoMed plans to initiate a global Phase 3 trial for neflamapimod in DLB patients in the second half of 2026, building on the promising results from the Phase 2b trial [9][12]

Late-breaking oral presentation by a leading global authority in Dementia with Lewy bodies (DLB) to highlight updated data from Phase 2b study on neflamapimod treatment for DLB New data demonstrating the utility of neflamapimod and its effects on key neurodegeneration biomarkers in DLB will also be highlighted in poster session BOSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced ...

Core Insights - CervoMed has aligned with the FDA on the design of a planned Phase 3 clinical trial for neflamapimod in patients with dementia with Lewy bodies (DLB), indicating progress in regulatory discussions and trial preparations [1][3] - The Phase 2b RewinD-LB trial results showed a 64% risk reduction in clinically significant worsening of DLB symptoms over 32 weeks, highlighting the drug's potential efficacy [2][3] - The company plans to initiate a global pivotal trial in the second half of 2026, with additional biomarker data from ongoing trials expected in 2026 [1][3] Clinical Development Updates - CervoMed reported that the 32-week treatment data from the RewinD-LB trial demonstrated a durable beneficial effect on clinical progression and significant reductions in plasma levels of a neurodegeneration biomarker [1][2] - The FDA's feedback on the trial design supports the proposed endpoints and patient enrichment strategy, which are crucial for a potential New Drug Application [3] - Initial biomarker data from a Phase 2a trial in frontotemporal dementia (FTD) and topline results from a recovery after stroke trial are anticipated in 2026 [1][3] Financial Performance - As of September 30, 2025, CervoMed had approximately $27.3 million in cash and equivalents, down from $38.9 million at the end of 2024, which is expected to fund operations into the third quarter of 2026 [5] - Grant revenue for the three months ended September 30, 2025, was approximately $0.3 million, a decrease from $1.9 million in the same period in 2024, attributed to the completion of the initial phase of the RewinD-LB trial [6] - Research and Development (R&D) expenses increased to approximately $6.0 million for the quarter, compared to $5.1 million in the same period in 2024, primarily due to higher personnel and consulting costs [7] Operational Highlights - CervoMed appointed Matthew Winton, Ph.D., as Chief Commercial and Business Officer and David Quigley to its Board of Directors in October 2025, indicating a strengthening of its leadership team [4] - The company’s lead drug candidate, neflamapimod, is designed to target neuroinflammation and neurodegeneration, with potential applications in DLB, recovery after ischemic stroke, and frontotemporal dementia [9][10]

Core Viewpoint - CervoMed has received FDA feedback that aligns with its proposed Phase 3 clinical trial design for neflamapimod, a drug targeting dementia with Lewy bodies (DLB), marking a significant step towards a potential New Drug Application submission [1][4] Phase 3 Trial Design and Regulatory Alignment - The Phase 3 trial will be a global, randomized, double-blind, placebo-controlled study involving approximately 300 DLB patients, set to begin in the second half of 2026 [2] - Patients with historical evidence of Alzheimer's disease will be excluded, and further enrichment will be achieved through a validated blood plasma test [2] - Participants will be randomized 1:1 to receive either neflamapimod or placebo for 32 weeks, followed by an additional 48-week extension with neflamapimod only [2] Primary and Secondary Endpoints - The primary endpoint will be the change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB), consistent with the recently completed Phase 2b trial [3] - Secondary endpoints will include the percentage of participants with a greater than 1.5-point increase in CDR-SB and other established cognitive and motor function measures [3] Advancing Toward Registration - CervoMed's CEO expressed satisfaction with the FDA's alignment on the trial design, emphasizing the potential of neflamapimod to transform care for DLB patients [4] - The company anticipates feedback from other global regulators and plans to provide further details on the Phase 3 trial design in early 2026 [4] About Dementia with Lewy Bodies - DLB is the second most common progressive dementia after Alzheimer's disease, affecting millions globally, with no approved treatments available in the U.S. or EU [5] About Neflamapimod - Neflamapimod is an investigational oral drug that inhibits a key enzyme involved in neuroinflammation and synaptic dysfunction, showing promise in restoring synaptic function and improving neuron health [6][7] - Clinical trials have demonstrated that neflamapimod is generally well tolerated and has shown efficacy in improving dementia severity and functional mobility in DLB patients [8]

Core Insights - CervoMed Inc. has appointed David Quigley to its Board of Directors, bringing extensive experience in business strategy and life sciences [1][2] - The appointment is strategic as CervoMed prepares for Phase 3 trials and commercialization of its lead drug candidate, neflamapimod, targeting dementia with Lewy bodies (DLB) [1][2] - DLB is a significant health issue with no approved treatments in the U.S. or EU, affecting millions globally [3][4] Company Overview - CervoMed is a clinical-stage biotechnology company focused on developing treatments for age-related brain disorders [4] - The lead drug candidate, neflamapimod, aims to restore communication between brain cells by inhibiting a key enzyme involved in inflammation and neurodegeneration [4] - The company recently completed a successful Phase 2b trial for neflamapimod in DLB patients and plans to initiate a global Phase 3 trial in mid-2026 [4] Industry Context - DLB is the second most common progressive dementia after Alzheimer's disease, characterized by cognitive decline, visual hallucinations, and motor symptoms similar to Parkinson's disease [3] - Current standard-of-care therapies for DLB only provide temporary symptom relief, highlighting the need for effective treatments [3]

Summary of CervoMed Inc. Conference Call Company Overview - **Company Name**: CervoMed Inc. - **Ticker Symbol**: CRBO - **Industry**: Clinical-stage biotechnology focused on neurological diseases - **Lead Product**: Neflamapimod, an investigational orally administered small molecule targeting p38 MAP kinase alpha Key Points and Arguments 1. **Market Opportunity**: Neflamapimod is entering phase three trials for dementia with Lewy bodies (DLB), a significant market with no approved therapies currently available [2][3] 2. **Disease Impact**: DLB is the third most common neurodegenerative disease, more impactful than Alzheimer's, with rapid progression leading to nursing home care within two years [3][4] 3. **Patient Population**: Approximately 50% of DLB patients are classified as pure DLB, representing a target population of 150,000 to 180,000 in the US, 280,000 to 420,000 in Europe, and 100,000 to 250,000 in Japan [6] 4. **Clinical Data**: Phase 2 studies showed significant improvements in dementia rating scales, gait, motor function, and biomarkers indicative of neurodegeneration [7][8] 5. **Phase 2b Study Design**: A larger phase 2b study with 159 patients is underway, focusing on the CDR-Sum of Boxes as the primary endpoint, which is a well-established measure for dementia severity [8][9] 6. **Drug Efficacy**: Batch B of the drug showed a 52% reduction in clinical progression on the CDR-Sum of Boxes scale compared to batch A, which was ineffective [13][15] 7. **Safety Profile**: Safety data has been favorable, with no severe adverse events leading to discontinuation, and minimal liver enzyme elevation observed [19] 8. **FDA Engagement**: Ongoing discussions with the FDA regarding phase three trial design, aiming for a 24-week placebo-controlled study with around 300 patients [19][26] Additional Important Insights 1. **Differentiation from Alzheimer's**: DLB symptoms occur earlier and are potentially reversible, making it an optimal target for intervention compared to Alzheimer's, where significant cell death complicates treatment [30][31] 2. **Biomarker Correlation**: The decrease in GFAP, a biomarker for neurodegeneration, correlates with clinical improvements, reinforcing the drug's efficacy [17][18] 3. **Future Directions**: CervoMed is also exploring treatments for recovery after stroke and frontotemporal dementia, indicating a broader pipeline beyond DLB [21][22] This summary encapsulates the critical aspects of CervoMed's conference call, highlighting the company's focus on DLB, the potential of neflamapimod, and the strategic direction moving forward.

Core Insights - CervoMed Inc. is a clinical-stage company focused on developing treatments for age-related neurologic disorders [3] - The company will present at the Emerging Growth Conference on October 22, 2025, with Matthew Winton, Ph.D., as the presenter [1][2] Company Overview - CervoMed is developing neflamapimod, an investigational orally administered small molecule that inhibits p38 mitogen-activated protein kinase alpha [3] - Neflamapimod aims to address synaptic dysfunction, a reversible aspect of neurodegenerative processes in disorders such as Dementia with Lewy Bodies (DLB) [3] - The company has recently completed a Phase 2b trial evaluating neflamapimod in patients with DLB [3]

Core Insights - CervoMed Inc. has released additional data from its Phase 2b RewinD-LB trial of neflamapimod for dementia with Lewy bodies, indicating potential efficacy in slowing disease progression [1] Trial Results - The final analyses of the RewinD-LB trial were conducted after the August 2025 database lock, covering a total of 48 weeks, which included a 16-week placebo-controlled phase followed by a 32-week neflamapimod-only extension phase [1] - In participants with plasma ptau181 levels below 21 pg/mL, there was a trend towards improvement with NFMD/A compared to placebo during the initial phase [2] - NFMD/B showed significant improvement over NFMD/A on the Clinical Dementia Rating Sum of Boxes (CDR-SB) with a change of −0.58 (p=0.024) during the first 16 weeks of the extension phase [3] - Transitioning from placebo to NFMD/B resulted in significant improvements in CDR-SB and ADCS-CGIC scores over respective 16-week periods [4] - NFMD/B reduced the risk of clinically meaningful progression by 67% compared to NFMD/A over 32 weeks and by 75% compared to placebo over 16 weeks [4] Biomarker Analysis - New analyses of plasma glial fibrillary acidic protein (GFAP) indicated that participants transitioning from placebo to NMFD/B experienced a significant reduction in plasma GFAP levels, estimated at 50% lower than during the placebo treatment [5] - In participants with low likelihood of Alzheimer's disease co-pathology, changes in plasma GFAP significantly correlated with changes in CDR-SB scores, indicating that reductions in GFAP were associated with lower dementia severity [6] Market Reaction - Following the announcement, CervoMed shares increased by 7.97% to $9.21, with an intraday high of $9.30 and a low of $8.64, although the stock remains 45.6% below its 52-week high [7]

Core Insights - CervoMed Inc. has reported significant improvements in the Phase 2b RewinD-LB trial for neflamapimod, particularly in participants with low likelihood of Alzheimer's disease co-pathology, as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) [1][2][3] - The company anticipates feedback from the U.S. Food and Drug Administration (FDA) regarding the Phase 3 trial design in Q4 2025 [1][2] Trial Results - The RewinD-LB trial included a 16-week placebo-controlled phase followed by a 32-week extension phase, with a focus on participants whose plasma ptau181 levels were below 21 pg/mL, indicating a low likelihood of Alzheimer's disease co-pathology [3][4][8] - In the initial phase, there was a trend towards improvement in CDR-SB for the drug product batch that did not achieve targeted plasma concentrations compared to placebo [6] - The extension phase showed significant improvement in CDR-SB and other cognitive measures for participants receiving the new drug product batch that achieved targeted plasma concentrations [6][10] Biomarker Analysis - Neflamapimod significantly reduced plasma GFAP levels, a biomarker of neurodegeneration, in participants who received the new drug product batch for 12 or more weeks [7][11] - In participants with low likelihood of Alzheimer's co-pathology, changes in plasma GFAP levels correlated significantly with changes in CDR-SB scores, indicating a relationship between biomarker effects and clinical outcomes [11] Company Background - CervoMed is focused on developing treatments for age-related neurologic disorders, with neflamapimod being an investigational small molecule aimed at treating synaptic dysfunction in dementia with Lewy bodies [9]