CervoMed Inc., a clinical-stage biotechnology company, engages in the development and commercialization of treatments for age-related neurologic disorders. The company is developing neflamapimod, an orally administered small molecule drug that crosses the blood–brain barrier and inhibits the enzyme p38a. Neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of dementia with Lewy bodies, non-fluent variant primary progressive aphasia, amyotrophic lateral sclerosis, and amyotrophic lateral sclerosis. CervoMed Inc. was founded in 2010 and is headquartered in Boston, Massachusetts.
CervoMed Announces Pharmacokinetic Results with New Neflamapimod Oral Tablet Formulation and Secures FDA Removal of Drug Exposure Limit
CervoMed announced PK, regulatory, and manufacturing advances enabling a higher-dose, twice-daily oral regimen of neflamapimod, its lead drug candidate for age-related brain disorders.
The FDA removed the prior plasma drug exposure limit after a 39-week dog toxicology study established a NOAEL more than 30-fold above the clinically active exposure range, and a new 50 mg tablet showed a PK profile suited to BID dosing, with roughly 20% lower peak and 20% higher 12-hour trough concentrations versus the prior capsule.
CervoMed plans to advance a 100 mg BID regimen expected to raise trough concentrations about 33% versus the prior 40 mg TID dosing, which management says reduces clinical execution and manufacturing risk as the program moves toward Phase 3 in dementia with Lewy bodies.
The company is still seeking a strategic partner to fund the Phase 3 DLB trial, and interim biomarker data from its Phase 2a nfvPPA trial are expected in early Q4 2026.