CervoMed (CRVO) The 38th Annual Roth Conference summary

Key insights and scientific presentations

• Neflamapimod, a potent p38α inhibitor, targets synaptic dysfunction in DLB, showing improved synaptic connectivity, reduced neurodegeneration markers, and improved neuron health in clinical studies.

• Functional MRI and FDG-PET data from Phase IIb studies demonstrated improved synaptic function and decreased hypometabolism during neflamapimod treatment.

• Phase IIa and IIb studies showed significant clinical improvements and biomarker reductions in DLB patients without AD co-pathology, especially with optimized drug formulation.

• DLB affects over 700,000 in the U.S., progresses rapidly, and lacks approved therapies in the U.S. or EU.

• Updated manufacturing and dosing (50 mg TID) address prior batch issues, aiming for consistent plasma levels and de-risked clinical outcomes.

Market opportunity and disease overview

• Pure DLB, without AD co-pathology, represents a substantial untapped specialty market with high unmet clinical need.

• DLB market estimated at 360,000 patients in the U.S. without AD co-pathology, with similar numbers in Europe and Asia.

• Estimated DLB prevalence is 720,000 in the US, 1,080,000 in Europe, and 600,000 in Japan, with about half lacking AD co-pathology.

• DLB progresses more rapidly than AD, significantly impacting quality of life and caregiver burden.

• Clinical improvements in CDR Sum of Boxes (1.1–2 point reduction) exceed those seen with anti-amyloid therapies.

Regulatory and clinical development plans

• Phase III trial design finalized with FDA and global regulators: 300 patients, 32 weeks, focusing on DLB without Alzheimer's co-pathology, using CDR Sum of Boxes as the primary endpoint.

• Alignment reached with FDA, EMA, and MHRA on the registration path for neflamapimod in DLB.

• A single Phase III, placebo-controlled trial is planned, using a 50mg TID dosing regimen, with initiation contingent on funding and formulation improvements.

• Confirmed dose and new stable crystal form of neflamapimod validated in preclinical and phase I studies, supporting phase III readiness.

• Phase III trial to start by year-end, leveraging established clinical sites and biomarker-enriched patient selection for higher efficacy.