Business
Quince Therapeutics Provides Business Update and Reports Third Quarter 2024 Financial Results
Phase 3 NEAT clinical trial on track with 32 patients enrolled to date with majority of U.S. and European study sites now enrolling patients SOUTH SAN
About this update from Quince Therapeutics, Inc.
[{"type":"text","content":"\nPhase 3 NEAT clinical trial on track with 32 patients enrolled to date with majority of U.S. and European study sites now enrolling patients\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nQuince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today provided an update on the company’s development pipeline and reported financial results for the third quarter ended September 30, 2024.\n\n\nDirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “We are pleased to report accelerating enrollment of our pivotal Phase 3 NEAT clinical trial in Ataxia-Telangiectasia (A-T). As of today, we have enrolled 32 patients with A-T across clinical sites in the U.S., U.K., and European Union. Additionally, the majority of planned NEAT study sites are now activated and open for enrollment. We expect enrollment momentum to continue as we work toward our commitment to complete enrollment in the second quarter of 2025 and report topline results in the fourth quarter of 2025.”\n\n\nPivotal Phase 3 NEAT Clinical Trial\n\n\n\nEnrolled 32 participants to date in the company’s Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T; IEDAT-04-2022/NCT06193200) clinical trial to evaluate the neurological effects of EryDex in patients with A-T.\n\n\n\nQuince 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.\n\n\n\nParticipants who complete the full treatment period, complete study assessments, and provide informed consent will be eligible to transition to an open label extension study, which will begin in the fourth quarter of 2024.\n\n\n\nPivotal Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).\n\n\n\nExpect to report Phase 3 NEAT topline results in the fourth quarter of 2025 with a New Drug Application (NDA) submission to the FDA and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) in 2026, assuming positive study results.\n\n\n\nNEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurolog...