Quince Therapeutics says FDA lifts partical clinical hold on EryDel’s EryDex IND

Quince Therapeutics announced that the U.S. Food and Drug Administration has lifted the partial clinical hold on EryDel S.p.A’s Investigational New Drug application for its lead Phase 3 asset, EryDex. Pending the closing of Quince’s acquisition of EryDel, Quince intends to advance the global Phase 3 NEAT clinical trial evaluating the safety and efficacy of EryDex for the potential treatment of a rare, fatal pediatric neurological disease, Ataxia-Telangiectasia. Currently, there are no approved treatments for patients with A-T and the market represents a $1+ billion estimated peak sales opportunity. Dirk Thye, M.D., Quince’s Chief Executive Officer, said, “We are pleased with the FDA’s decision to lift the partial clinical hold related to EryDel’s lead asset, EryDex. We look forward to completing the clinical and regulatory activities necessary to advance EryDex into the Phase 3 NEAT study – with patient enrollment beginning as soon as the second quarter of 2024. Notably, this pivotal trial will be conducted under a Special Protocol Assessment (SPA) that has already been reviewed with the FDA, which should allow for the submission of a New Drug Application (NDA) following completion of this single study, assuming positive results.” Quince’s acquisition of EryDel is subject to certain regulatory approvals, including the foreign direct investment screening clearance in Italy, and other closing conditions and is expected to close in the fourth quarter of 2023.