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Quince Therapeutics Announces First Patient Dosed in Phase 3 Clinical Trial of EryDex for the Treatment of Ataxia-Telangiectasia
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug
About this update from Quince Therapeutics, Inc.
[{"type":"text","content":" SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nQuince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today announced that the first patient has been dosed in the company’s Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial to evaluate the neurological effects of EryDex in patients with Ataxia-Telangiectasia (A-T). This pivotal Phase 3 study will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food & Drug Administration (FDA).\n\n\n“The initiation of our pivotal Phase 3 NEAT study is a major milestone for Quince, and an opportunity for patients living with the devastating effects of Ataxia-Telangiectasia to participate in research seeking to identify a beneficial therapeutic solution,” said Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer. “There are currently no approved therapeutic treatments in any global market for this rare pediatric disease, and our primary corporate objective is to change that for patients with A-T and their families.”\n\n\nThe Phase 3 NEAT clinical trial (#IEDAT-04-2022/NCT06193200) is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of EryDex in patients with A-T. The study plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older. Participants will be randomized (1:1) between EryDex or placebo and treatment will consist of six infusions scheduled every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in rescored modified International Cooperative Ataxia Rating Scale (RmICARS). Participants who complete the full treatment period, complete the study assessments, and provide informed consent will be eligible to transition to an open label extension (OLE) study. Quince expects to report Phase 3 NEAT topline results in the second half of 2025 with a potential New Drug Application (NDA) submission in 2026, assuming positive study results.\n\n\nWith the achievement of the first patient enrolled in this study, Quince ...