Quince Therapeutics Announces Topline Results from Pivotal Phase 3 NEAT Clinical Trial of eDSP in Ataxia-Telangiectasia
Quince TherapeuticsQuince Therapeutics(US:QNCX) Businesswire·2026-01-29 20:10

Core Insights - Quince Therapeutics announced that the pivotal Phase 3 NEAT clinical trial of eDSP in Ataxia-Telangiectasia did not achieve statistical significance for its primary and key secondary endpoints [1] - The company will cease the clinical development of eDSP and intends to preserve cash while exploring available options [1] Group 1: Clinical Trial Results - The NEAT study involved 105 participants and was a randomized, double-blind, placebo-controlled trial [1] - The primary endpoint, measured by the change from baseline to month six using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS), showed a mean change of 0.94 in the active arm compared to 2.24 in the placebo arm, with a p-value of 0.0851 [1] - The key secondary endpoint, improvement in Clinical Global Impression of Severity (CGI-S), also did not reach significance with a p-value of 0.522 [1] Group 2: Safety and Tolerability - eDSP was generally well tolerated, with no clinically meaningful safety concerns identified [1] - The most common adverse events reported in the eDSP arm included pruritis and pyrexia [1] Group 3: Background on Ataxia-Telangiectasia - Ataxia-Telangiectasia (A-T) is a rare inherited neurodegenerative disorder caused by mutations in the ATM gene, leading to severe neurological symptoms and a median lifespan of approximately 25 to 30 years [1] - There are approximately 4,600 diagnosed patients with A-T in the U.S., with an estimated 5,000 patients in the U.K. and EU4 countries, and currently no approved therapeutic treatments for A-T [1] Group 4: About eDSP - eDSP consists of dexamethasone sodium phosphate encapsulated in a patient's own red blood cells, designed to provide the efficacy of corticosteroids while reducing adverse effects [1] - The eDSP System utilizes Quince's proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology, which aims to enhance drug delivery and tolerability [1]

Quince Therapeutics Announces Topline Results from Pivotal Phase 3 NEAT Clinical Trial of eDSP in Ataxia-Telangiectasia - Reportify