CervoMed

FDA granted orphan drug designation to CervoMed’s neflamapimod for frontotemporal dementia (FTD) treatment. CervoMed pauses phase 3 trial for dementia with Lewy bodies (DLB) after phase 2b trial didn’t meet primary endpoints, citing lower-than-expected drug concentrations. Neflamapimod targets p38MAP kinase alpha, showing potential despite setbacks.

Researchers identified 13 proteins predicting brain aging speed; midlife anxiety often precedes dementia; tavapadon improved Parkinson's symptoms; neflamapimod failed in dementia with Lewy bodies; cortical sulcus neurodegeneration linked to CTE; ALS/cancer patients more likely to choose assisted dying; former soccer players at higher dementia risk; diverse brain cells contribute to Alzheimer's neuroinflammation; media highlighted Alzheimer's and Parkinson's stories.

Neflamapimod failed to show statistically significant effects vs. placebo on primary and secondary endpoints in a 16-week Phase 2b trial for dementia with Lewy bodies (DLB). Target plasma drug concentrations were not achieved, potentially impacting results. The drug showed favorable safety and tolerability with no new safety signals. Trial participants continue in an open-label extension. CervoMed is analyzing data to understand outcomes and future development paths.

CervoMed's RewinD-LB Phase 2b trial for neflamapimod in dementia with Lewy bodies did not meet primary or secondary endpoints at 16 weeks, with target plasma drug concentrations not achieved. Despite this, neflamapimod showed favorable safety and tolerability. Further analysis and open-label extension data are anticipated in 2025.

CervoMed's Neflamapimod receives FDA Orphan Drug Designation for frontotemporal dementia treatment, based on Phase 1 and 2 study results. The drug, targeting p38MAP kinase, showed efficacy in early-stage dementia with Lewy bodies (DLB) and is planned for Phase 3 trial in DLB by mid-2025.

FDA grants orphan drug designation to CervoMed's neflamapimod for frontotemporal dementia, causing a 14.6% stock rise. The drug, also studied for early-stage dementia with Lewy bodies, aims for Phase III trial in mid-2025 and regulatory submission in 2027. Neflamapimod, an oral p38a inhibitor, showed promising results in earlier trials, targeting synaptic dysfunction in dementia.

FDA grants orphan drug designation to CervoMed's neflamapimod for frontotemporal dementia, causing a 14.6% stock rise. The drug is also in Phase IIb trials for early-stage dementia with Lewy bodies, with Phase III expected in mid-2025. Neflamapimod, a p38MAP kinase alpha inhibitor, aims to treat synaptic dysfunction in dementia.

Dementia with Lewy bodies (DLB), affecting 1.4 million in the U.S., ranks second among dementias and third among neurodegenerative diseases. Despite its prevalence, DLB remains underdiagnosed and lacks approved treatments.

CervoMed Inc. wins Prix Galien USA 2024 Best Startup award for developing potential treatment for Dementia with Lewy bodies (DLB), a condition affecting over 1.4 million patients in the U.S. and EU. The company's drug, neflamapimod, is in Phase 2b clinical trial, with topline results expected in December 2024.

Neflamapimod reduces plasma GFAP levels in DLB, improving clinical outcomes. The RewinD-LB Phase 2b trial targets DLB patients without tau pathology, enhancing treatment effect detection.