The Food and Drug Administration (FDA) has granted Fast Track designation to neflamapimod (EIP Pharma) for the treatment of dementia with Lewy bodies (DLB).

DLB is characterized by progressive dementia, fluctuating cognition, sleep disturbances, visual hallucination, and parkinsonism. Neflamapimod is a brain-penetrant, oral small molecule that inhibits the intra-cellular enzyme p38 MAP kinase alpha (p38α), which is expressed in neurons under conditions of stress and disease and plays a role in synaptic dysfunction.

The designation is supported by data from the ongoing 16-week, multicenter, double-blind, placebo-controlled, proof-of-concept phase 2 AscenD-LB study of neflamapimod in mild-to-moderate DLB. The primary end point is the change from baseline in the composite score of study-specific Cogstate Neurological Test Battery (NTB), including assessments of attention, executive function and visuospatial deficits. Secondary end points include the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), neuropsychiatric inventory (NPI-10), quantitative EEG parameters, international shopping list test, among others. 

Study data is expected to be available in the second half of 2020.

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Additionally, the Company recently announced the clinical trial results from the phase 2b REVERSE-SD study of neflamapimod for early Alzheimer disease. Neflamapimod is currently being investigated in a phase 2 trial in patients with Huntington disease who have evidence of cognitive dysfunction.

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