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 the positive outcome of its pre-planned safety analysis conducted by an independent data and safety monitoring board (iDSMB) for the company’s ongoing 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 iDSMB recommended that the study continue without any modifications.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “The positive outcome from our recent iDSMB review of eDSP reaffirms our confidence in the favorable safety profile of eDSP to date. As we continue to advance eDSP as a potential first-to-market A-T treatment, we are pleased that no safety concerns have been identified as our pivotal Phase 3 NEAT study progresses. We remain on track to report topline results from the study in the first quarter of 2026.”
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 consists of two cohorts randomized (1:1) between eDSP or placebo and treatment includes 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.
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]