US-based EIP Pharma has dosed the first patient in its RewinD-LB clinical trial of neflamapimod for the treatment of patients with dementia with Lewy bodies (DLB).
The biopharmaceutical company has launched its Phase IIb trial (NCT05869669) of pipeline drug neflamapimod (VX-745) following a positive readout of a Phase IIa trial AscenD-LB.
Neflamapimod was granted Fast Track status by the US Food and Drug Administration (FDA) for the treatment of DLB. It is also under development for the treatment of Alzheimer’s disease, cognitive defects in Huntington’s disease and acute ischaemic stroke.
EIP Pharma CEO and co-principal investigator Dr John Alam said: “The dosing of the first patient in Phase IIb is a major step forward in our journey towards bringing potentially life-changing treatments to patients living with DLB and other neurodegenerative diseases.
“The results of this trial could help substantiate the positive readout we saw in Phase IIa, in which neflamapimod significantly improved cognition and function in patients with DLB. More notably, positive results in the RewinD-LB study would bring us closer to the first approved therapy for patients living with DLB.”
Phase IIb RewinD-LB
The RewinD-LB study is a randomised, double-blind, placebo-controlled phase IIb clinical trial of oral 40mg neflamapimod, three times daily. Researchers are hoping to enrol 160 patients with prodromal DLB or mild dementia due to DLB in the 16-week trial.
All patients completing the placebo-controlled main study will receive an additional 32 weeks of neflamapimod on an open-label basis.
Patients with Alzheimer’s disease-related co-pathology, assessed by a blood biomarker, will be excluded from participation in the study.
How neflamapimod works
Neflamapimod acts as an inhibitor of the alpha isoform of the protein enzyme p38 mitogen-activated protein kinase (p38 MAPK alpha). The p38 MAPK alpha modulates signalling pathways downstream of the microglial receptors and is expressed in neurons. It also modulates memory formation through effects on long-term potentiation or depression.
In Phase I and II clinical studies, neflamapimod has been generally well tolerated. Results from the Phase IIa clinical study demonstrated significant improvement in dementia severity and motor function compared to placebo. Patients who received the highest dose reported improved cognition.