Quince Therapeutics says Phase 3 NEAT trial of eDSP did not meet endpoints

Quince Therapeutics (QNCX) announced topline results from its pivotal Phase 3 NEAT clinical trial evaluating its lead asset, dexamethasone sodium phosphate encapsulated in autologous erythrocytes, in patients with Ataxia-Telangiectasia. In the NEAT study, the company’s pivotal Phase 3 international, multicenter, randomized, double-blind, placebo-controlled study, the primary endpoint, which measured the change from baseline to last efficacy visit at month six using the Rescored modified International Cooperative Ataxia Rating Scale compared to placebo, did not reach statistical significance. The mean change from baseline to month six was 0.94 in the active arm compared to 2.24 in the placebo arm with a p-value of 0.0851. Furthermore, the study did not meet its key secondary endpoint of improvement in Clinical Global Impression of Severity measured from baseline to month six with a p-value of 0.522. eDSP was generally well tolerated and there were no clinically meaningful safety concerns identified. The most common adverse events reported in the eDSP arm included pruritis and pyrexia.