CervoMed (CRVO) H.C. Wainwright 28th Annual Global Investment Conference summary

Program progress and clinical development

• Significant progress reported in the neflamapimod clinical program for dementia with Lewy bodies (DLB), including expansion into other neurodegenerative diseases.

• Two phase 2 studies in DLB showed replicated clinical data, supporting advancement toward phase III trials and regulatory engagement.

• Manufacturing and non-clinical aspects have advanced, with a new stable drug formulation developed to ensure consistent dosing.

• Regulatory agencies globally have aligned on the primary endpoint (CDR Sum of Boxes) and trial design for phase III.

• Strategic partnership efforts are underway to finance the upcoming phase III program.

Mechanism of action and disease insights

• Neflamapimod targets p38 alpha kinase, a key driver of neuroinflammation implicated in DLB and other disorders.

• Neuroinflammation, particularly involving interleukin-1 beta and interleukin-6, is central to DLB pathology.

• The drug demonstrates potent inhibition of these cytokine pathways at clinically relevant concentrations.

• Mechanistic models and animal studies validate the drug’s effect on reversing disease processes linked to neuroinflammation.

• The approach may have broader applications in diseases like Alzheimer's, ALS, and Down syndrome.

Clinical data and outcomes

• Phase 2a and 2b studies showed significant reduction in disease progression, especially in patients with pure DLB and low Alzheimer's pathology markers.

• MRI data from phase 2b indicated reversal of brain atrophy in treated patients compared to placebo.

• Efficacy was linked to achieving target blood concentrations; formulation issues in one batch were identified and resolved.

• New formulation (50 mg TID) is expected to achieve target concentrations in over 90% of patients.

• Secondary endpoints and biomarkers, such as plasma GFAP, also showed improvement with effective dosing.