CervoMed announces ODD granted to neflamapimod by U.S. FDA

CervoMed (CRVO) announced that its oral investigational drug neflamapimod has been granted Orphan Drug Designation, ODD, by the U.S. Food and Drug Administration, FDA, for the treatment of frontotemporal dementia, FTD. “We are pleased to have received Orphan Drug Designation as it implicitly recognizes the scientific rationale and potential for neflamapimod to treat this debilitating condition. Patients diagnosed with frontotemporal dementia have no available treatment options, and this rare condition is extremely burdensome to patients and caregivers alike,” said John Alam, MD, Chief Executive Officer of CervoMed. “Within this year, there have been multiple scientific presentations and publications that indicate neflamapimod targets specific pathogenic mechanisms associated with FTD. We are in active discussions with clinical thought leaders regarding the design of a proof-of-principle study in FTD, while continuing to prepare to advance neflamapimod into a Phase 3 trial in DLB in mid-2025.”