CervoMed announced positive results from the first 16 weeks of the extension phase of the phase 2b RewinD-LB study of its lead drug candidate, an oral stress kinase inhibitor, in the treatment of dementia with Lewy bodies (DLB).
DLB is the third most common degenerative disease of the brain (after Alzheimer’s disease and Parkinson’s disease). To date, there are no FDA approved drugs for the management of DLB.
CervoMed had shared topline results from the RewinD-LB phase 2b trial back in December, reporting that the trial, evaluating neflamapimod, did not meet statistical significance thresholds for its primary endpoint of change in the clinical Dementia Rating Sum of Boxes or any of its key secondary endpoints.
However, pharmacokinetic data suggested that the capsules used during the trial — from an older batch — may have had lower-than-expected bioavailability, potentially explaining the lack of significant efficacy.
In the open-label extension trial, 149 participants from the initial trial were all given neflamapimod — 55 patients received the same batch of capsules utilized in the initial phase and 94 received a new batch of capsules. The new batch of neflamapimod capsules led to increased plasma drug concentrations and demonstrated improvement (p<0.001 vs. old capsules; p=0.003 vs. placebo) on the primary outcome measure — change from baseline in Clinical Dementia Rating Sum of Boxes. Additionally, the incidence of falls was lower in participants who received the new capsules compared to those who received old Capsules during the extension.
Neflamapimod, a p38 MAP kinase alpha enzyme inhibitor, has changed hands a few times. The drug was first discovered by Vertex Pharmaceuticals and then licensed by EIP Pharma in 2014. In 2023, CervoMed merged with EIP, picking up the drug candidate.