CervoMed: Neflamapimod Phase 2b Trial In Dementia With Lewy Bodies Patients Fails To Meet Targets

(RTTNews) - CervoMed Inc. (CRVO) announced Tuesday that its RewinD-LB Phase 2b clinical trial evaluating neflamapimod in patients with dementia with Lewy bodies or DLB failed to demonstrate statistically significant effects versus placebo on primary and secondary endpoints at 16 weeks.

In the RewinD-LB Phase 2b trial, neflamapimod showed a favorable safety and tolerability profile that is consistent with prior clinical studies, with no new safety signal identified.

The full data set from the double-blind phase of the RewinD-LB trial is expected to be available to the Company in January 2025. The data from the first 16 weeks of the open label extension portion of the trial are expected to be available in the late second quarter of 2025.

In the meantime, the company is pausing all preparations for its previously planned Phase 3 trial in early-stage DLB until the full analysis is complete.

The company added that the trial participants continue to receive neflamapimod during open-label extension.

The clinical-stage company focused on developing treatments for age-related neurologic disorders noted that the trial did not meet statistical significance thresholds for its primary endpoint of change in the Clinical Dementia Rating Sum of Boxes or CDR-SB or any of its key secondary endpoints. These included change from baseline in Timed Up and Go or TUG test, change from baseline in a Neuropsychological Test Battery or NTD and the Clinician's Global Impression of Change or CGIC.

Initial analysis shows that target plasma drug concentrations were not achieved during the double-blind phase of the trial, which may have adversely impacted trial results.

John Alam, Chief Executive Officer of CervoMed, said, "Obviously, we are disappointed with these results, particularly given our prior clinical experience with neflamapimod in patients with early-stage DLB and we are investigating the reasons for the lower-than-expected plasma drug concentrations. We continue to believe neflamapimod may have potential as a treatment for DLB, and we will thoroughly analyze the clinical and pharmacokinetic data from the trial to better understand its outcome and potential future development paths for the drug."

On the Nasdaq, CervoMed shares closed Monday's regular trading at $10.25, down 13.94 percent.

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