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SOUTH SAN FRANCISCO - Quince Therapeutics, Inc. (Nasdaq:QNCX) announced Monday that its pivotal Phase 3 clinical trial for encapsulated dexamethasone sodium phosphate (eDSP) in Ataxia-Telangiectasia (A-T) patients will continue without modifications following a positive safety review.
An independent data and safety monitoring board identified no safety concerns in its pre-planned analysis of the NEAT clinical trial, which is evaluating eDSP as a potential first-to-market treatment for A-T, a rare genetic disorder.
"The positive outcome from our recent iDSMB review of eDSP reaffirms our confidence in the favorable safety profile of eDSP to date," said Dirk Thye, Quince's Chief Executive Officer and Chief Medical Officer, in a press release statement.
The Phase 3 NEAT study is an international, multicenter, randomized, double-blind, placebo-controlled trial with two cohorts randomized in a 1:1 ratio between eDSP or placebo. Treatment includes six infusions scheduled once every 21 to 30 days.
The primary efficacy endpoint will measure change from baseline using the Rescored modified International Cooperative Ataxia Rating Scale compared to placebo. The company expects to report topline results in the first quarter of 2026.
eDSP utilizes Quince's proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology platform, which encapsulates dexamethasone sodium phosphate in a patient's own red blood cells. This approach aims to provide the anti-inflammatory benefits of corticosteroids while potentially reducing the adverse effects associated with chronic corticosteroid treatment.
The company's AIDE technology leverages red blood cells as drug delivery vehicles, potentially offering benefits including better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolonged circulating half-life.
In other recent news, Quince Therapeutics announced the publication of a pharmacokinetic modeling study for its lead asset, the enhanced Delivery Steroid Platform (eDSP), in the journal CPT: Pharmacometrics & Systems Pharmacology. This study focused on eDSP's use in pediatric patients with Ataxia-Telangiectasia (A-T) and healthy adults. Quince Therapeutics also presented data on walking capacity in children with A-T at the 54th Child Neurology Society Annual Meeting. The company maintains its Market Outperform rating from both Citizens and JMP Securities, with a price target of $8.00, highlighting confidence in eDSP's potential. Citizens noted the ongoing Phase 3 NEAT trial and assigned a 60% probability of success to it. Additionally, Quince Therapeutics amended its credit facility with the European Investment Bank, reducing the required minimum cash balance for a specific period in 2026. This amendment also involves a conversion of a portion of the deferred interest rate into a fixed rate. These developments reflect ongoing progress and strategic adjustments by Quince Therapeutics.
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