Business
Quince Therapeutics Announces The Lancet Neurology Publication of Phase 3 ATTeST Clinical Trial Data Evaluating EryDex for the Treatment of Ataxia-Telangiectasia (A-T)
Findings from largest completed study in A-T demonstrated favorable safety profile Study showed positive effect of EryDex treatment in a subset of patients
About this update from Quince Therapeutics, Inc.
[{"type":"text","content":"\nFindings from largest completed study in A-T demonstrated favorable safety profile\n\n\nStudy showed positive effect of EryDex treatment in a subset of patients with A-T ages six to nine – the age range that typically experiences rapid clinical decline\n\n\nQuince recently initiated pivotal Phase 3 NEAT study, which is currently enrolling and being conducted under U.S. FDA Special Protocol Assessment agreement\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 announced the online publication of data in The Lancet Neurology from its Phase 3 ATTeST (Ataxia-Telangiectasia Trial with the EryDex SysTem; #IEDAT-02-2015/NCT02770807) clinical trial evaluating the safety and efficacy of its lead asset, EryDex (dexamethasone sodium phosphate encapsulated in autologous erythrocytes), for the treatment of A-T.\n\n\n“The results of this study demonstrate the encouraging efficacy and safety profile of our lead asset, EryDex, for the treatment of patients with A-T, a rare pediatric disease with vast unmet need and no approved treatments,” said Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer. “These findings provide us with additional confidence in our pivotal Phase 3 study of EryDex now underway with a primary analysis population comprised of patients with A-T experiencing the most rapid clinical decline – children ages six to nine – in addition to including participants who are ten years of age or older.”\n\n\nThe Lancet Neurology Publication Highlights\n\n\nThe Lancet Neurology publication entitled Safety and efficacy of intra-erythrocyte dexamethasone sodium phosphate in children with ataxia-telangiectasia (ATTeST): a multicenter, randomized, double-blind, placebo-controlled phase 3 trial describes safety and efficacy results from the Phase 3 ATTeST clinical trial.\n\n\nHighlights include:\n\n\n\nATTeST was the largest completed study in A-T, with 175 participants conducted at 22 academic institutions and medical centers on five continents in 12 different countries.\n\n\n\n\nATTeST was a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy of two dose levels of EryDex compared to p...