Quince Therapeutics, Inc. has announced today that the U.S. Food and Drug Administration has granted Fast Track designation for its EryDex System for the treatment of Ataxia-Telangiectasia. This system employs a novel drug delivery technology that utilizes the patient's own biology to encapsulate dexamethasone sodium phosphate (DSP) within their red blood cells through Quince’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) platform.

EryDex aims to harness the anti-inflammatory properties of corticosteroids, like DSP, while mitigating the adverse effects associated with their long-term use, such as adrenal suppression. This designation highlights the pressing need for effective treatments for A-T, a severe and life-threatening condition impacting approximately 10,000 patients in the U.S., U.K., and EU4 countries.

Quince's earlier Phase 3 study (#IEDAT-02-2015/NCT02770807) demonstrated promising efficacy and safety results, prompting the initiation of a global Phase 3 NEAT clinical trial (#IEDAT-04-2022/NCT06193200) to further investigate EryDex's neurological effects in A-T patients. Conducted under a Special Protocol Assessment (SPA) agreement with the FDA, this pivotal trial aims to enroll around 86 patients aged six to nine years old (primary analysis group) and approximately 20 patients aged 10 years or older.

Dr. Dirk Thye, Quince’s CEO and CMO, emphasized the significance of Fast Track status and the ongoing Phase 3 trial in addressing the unmet medical needs of A-T patients. A-T, an autosomal recessive neurodegenerative disorder caused by ATM gene mutations, typically manifests before age five and progresses with severe neurological symptoms, leading to reduced life expectancy and significant morbidity.

EryDex, with its unique delivery system leveraging the patient's red blood cells, holds promise as a potential therapeutic solution for A-T, offering hope to patients and their families grappling with this devastating condition.

 

Source: businesswire.com

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