The Food and Drug Administration (FDA) has granted fast track designation to neflamapimod (EIP Pharma Inc, Boston, MA) as a potential treatment for dementia with Lewy bodies (DLB).
In the phase 2 REVERSE-SD study of neflamapimod (NCT03402659) for early-stage Alzheimer's disease (AD) met its secondary objectives of target engagement and proof-of-mechanism by demonstrating statistically significant reductions relative to placebo in cerebrospinal fluid (CSF) levels of phospho-tau and tau, major markers of neurodegeneration and axonal damage. The study did not meet its primary objective, however, of improving episodic memory at the end of the study period at week 24, as measured by Hopkins Verbal Learning Test (HVLT) and secondarily, the Wechsler Memory Scale (WMS) immediate and delayed recall.
The FDA's fast track program facilitates the development and review of drugs intended to treat serious conditions that fill an unmet medical need. A drug development program with fast-track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review, and potential approval to get important new drugs to individuals earlier.
A phase 2 double-blind, placebo-controlled, 16-week treatment proof-of-concept study (AscEND-LB; (NCT04001517) of neflamapimod for mild-to-moderate DLB called is currently enrolling participants. The primary objective is to determine whether neflamapimod can improve synaptic dysfunction in individuals with DLB, as assessed by a neuropsychological test battery evaluating attention, executive function and visuospatial deficits.