CervoMed, Inc. (CRVO) announced on Wednesday that its oral investigational drug, neflamapimod, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of frontotemporal dementia (FTD).
The company highlighted that individuals diagnosed with frontotemporal dementia currently lack any available treatment options, making this rare condition particularly challenging for both patients and caregivers.
This designation highlights the significant unmet need in the treatment of frontotemporal dementia and the potential applicability of neflamapimod across multiple neurological disorders.
The FDA grants Orphan Drug Designation to investigational therapies that target rare diseases or conditions affecting fewer than 200,000 individuals in the United States.
Achieving Orphan Drug status offers benefits for drug developers, such as support during the drug development process, tax incentives for clinical research costs, exemptions from certain FDA fees, and seven years of exclusivity in the market following approval.
CervoMed is on schedule to release preliminary findings from the RewinD-LB Phase 2b clinical trial, which focuses on early-stage dementia with Lewy bodies (DLB), in December 2024.
The company is also preparing to advance neflamapimod into a Phase 3 trial for early-stage DLB by mid-2025.
