CervoMed selects 50 mg Phase 3 dose

• CervoMed reported that neflamapimod’s clearest treatment signals occurred in “pure” DLB patients with adequate drug exposure.
• CRVO shares were down 7.3% at $3.31 before regular U.S. trading began.
• The company selected a 50 mg three-times-daily dose for planned Phase 3 studies after discussions with multiple regulators.

CervoMed (NASDAQ:CRVO) reported new Phase 2b analyses linking neflamapimod benefits to low pTau181 levels and sufficient drug exposure in the 159-patient RewinD-LB trial.

The placebo-controlled study missed its overall objective, which CervoMed attributed to excess Alzheimer’s co-pathology and a capsule batch producing lower-than-expected plasma concentrations.

Neflamapimod slowed right basal forebrain atrophy, increased related brain connectivity and showed clinical and biomarker improvements near a plasma trough threshold of 4 ng/mL.

CervoMed said 50 mg three times daily should place about 90% of patients above that threshold.

A separate 24-week study involving 26 patients found that 80 mg twice daily met its safety, tolerability and pharmacokinetic objectives, although its clinical findings were open-label.

CervoMed is seeking a strategic partner to finance Phase 3 development while continuing neflamapimod studies in primary progressive aphasia and amyotrophic lateral sclerosis.