SOUTH SAN FRANCISCO, Calif. –– Quince 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 that the last patient has completed their last visit in the company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP in Subjects with A–T; NCT06193200/IEDAT-04-2022) clinical trial of its lead asset, encapsulated dexamethasone sodium phosphate (eDSP), in patients with Ataxia-Telangiectasia (A-T). The company expects to report topline results from this study in the middle of the first quarter of 2026.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “Completing our pivotal Phase 3 NEAT clinical trial marks a major milestone for Quince as we rapidly move toward reporting topline results in the middle of the first quarter of 2026. Conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration, the study was powered at approximately 90% for a treatment difference versus placebo associated with a statistically significant and clinically meaningful treatment difference in a previous trial. The study has been executed with low rates of discontinuations and missing visits – all of which we believe enhance our probability of success. In addition, an unblinded, independent data safety monitoring board has met three times during the course of the study with no safety concerns identified.
“Quince believes that eDSP has great potential to improve the lives of patients living with A-T, a devastating pediatric neurodegenerative rare disease with no currently approved treatments. We are grateful for the participation of patients and their families, as well as the close collaboration with principal investigators and patient advocacy organizations in the U.S. and Europe who made the NEAT study possible,” concluded Dr. Thye.
Quince’s pivotal Phase 3 NEAT study is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of eDSP in patients with A-T. This study consisted of two cohorts randomized (1:1) between eDSP or placebo and the treatment included six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. Quince enrolled a total of 105 participants in the NEAT study, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years and older, and all but one of the participants elected to transition to the open label extension (OLE) study (NCT06664853/IEDAT-04-2022).
About eDSP
eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment.
eDSP leverages Quince’s proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response.
About Quince Therapeutics
Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube.
Media & Investor Contact
Stacy Roughan
Quince Therapeutics, Inc.
Vice President, Corporate Communications & Investor Relations
[email protected]