On 7 November, EIP Pharma, a clinical stage therapeutics company focused on treatments for neurodegenerative diseases, presented findings from the Phase II study of neflamapimod in mild-to-moderate dementia with Lewy bodies (DLB) at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) meeting. During his oral presentation entitled “The p38α kinase inhibitor neflamapimod significantly improves cognition in patients with mild-to-moderate dementia with Lewy bodies”, John J Alam from EIP pharma presented the full results of the AscenD-LB study.
The AscenD-LB study was a Phase II randomised, double-blind and placebo-controlled trial evaluating the effect of neflamapimod in people with DLB. 91 research participants were enrolled in the US and the Netherlands, they received capsules of neflamapimod or placebo with food for 16 weeks.
Findings showed that neflamapimod was very well tolerated with no treatment discontinuation due to study drug-related adverse events. The AscenD-LB study met its primary endpoint by demonstrating a significant improvement on cognition in participants receiving neflamapimod three times daily compared to those receiving either placebo or neflamapimod twice daily, as assessed by the Neuropsychological Test Battery (NTB). The NTB, designed to primarily evaluate attention and executive function, was assessed at baseline, week 4, week 8 and week 16. The positive effect on the NTB was evident at week 4 and was maintained throughout the 16-week study period. Furthermore, statistically significant improvements or trends were evident on multiple secondary clinical endpoints.
"The demonstrated positive effects on the AscenD-LB study's primary endpoint, cognition, and as well as on a number of secondary endpoints, establishes proof-of-concept for neflamapimod as a possible treatment for patients with dementia with Lewy bodies. If these findings are confirmed in phase 3 clinical studies, neflamapimod could potentially become the first approved therapy for this devastating disease," said Stephen Gomperts, an investigator in the AscenD-LB study.
