CervoMed Says FDA Grants Orphan Drug Designation For Neflamapimod In Frontotemporal Dementia

(RTTNews) - CervoMed, Inc. (CRVO) announced Wednesday that its oral investigational drug neflamapimod has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of frontotemporal dementia (FTD).

The company said patients diagnosed with frontotemporal dementia have no available treatment options, and this rare condition is extremely burdensome to patients and caregivers alike

The designation underscores significant unmet need in frontotemporal dementia and the potential role of neflamapimod in multiple neurologic disorders.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.

Orphan Drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

The company is on track to report topline data from the RewinD-LB Phase 2b clinical trial in early-stage dementia with Lewy bodies (DLB) in December 2024.

The company is continuing to prepare to advance neflamapimod into a Phase 3 trial in early-stage DLB in mid-2025.