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CervoMed Announces Orphan Drug Designation Granted to Neflamapimod by U.S. Food and Drug Administration for the Treatment of Frontotemporal Dementia
Designation underscores significant unmet need in frontotemporal dementia and the potential role of neflamapimod in multiple neurologic disorders On track to
About this update from Cervomed Inc.
[{"type":"text","content":"Designation underscores significant unmet need in frontotemporal dementia and the potential role of neflamapimod in multiple neurologic disorders 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 BOSTON, Nov. 27, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related neurologic disorders, today announced 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). “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.” FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Importantly, the FDA also requires sufficient preclinical and/or clinical data to establish a medically plausible basis for expecting the drug to be effective in the rare disease for which orphan drug status is granted. 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. About Frontotemporal DementiaFTD is a rare neurodegenerative disease, but it is one of the most common causes of early onset dementia. It affects an estimated 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Lat...