Quince Therapeutics, Inc., a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its EryDex System for the treatment of patients with Ataxia-Telangiectasia (A-T). EryDex is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells utilizing Quince’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology platform. DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. EryDex is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic corticosteroid treatment.
Fast Track designation has been granted based on the potential for EryDex to address a high unmet medical need for patients with A-T, a serious and life-threatening condition, and represents a significant regulatory milestone for Quince. There are currently no approved therapeutic treatments in any global market for this rare pediatric disease.
A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder with an estimated prevalence of approximately 10,000 patients with A-T in the U.S., U.K., and EU4 countries. Data from a prior Phase 3 study of EryDex showed encouraging efficacy results and a favorable safety profile. Quince is actively enrolling participants for its global Phase 3 NEAT clinical trial to evaluate the neurological effects of EryDex in patients with A-T, with plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients ages 10 years or older. This pivotal Phase 3 clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “The granting of Fast Track status for EryDex System marks another important milestone in our endeavor to identify a beneficial therapeutic solution for patients with A-T. We have initiated our pivotal Phase 3 NEAT clinical trial, which is being conducted in the U.S., U.K., and the European Union.”