The first patient has been dosed in EIP Pharma’s Phase IIb trial of neflamapimod for the treatment of patients with dementia with Lewy bodies. Image credit: designer491 / Getty Images.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.”

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.