Quince Therapeutics gains FDA Fast Track Designation for EryDex System
Betsy Goodfellow | June 4, 2024 | News story | Medical Communications | EryDex, FDA, Quince Therapeutics, Rare Diseases, fast track designation
Quince Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its EryDex System which focuses on the treatment of patients with Ataxia-Telangiectasia (A-T).
According to the company’s press release, ‘EryDex is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells utilising Quince’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology platform’.
This Fast Track Designation is intended to address the high medical needs which are currently being unmet for patients with A-T, as well as marking a significant regulatory milestone for the company. There are currently no approved therapeutic treatments for this rare paediatric disease in any global market.
Data from a phase 3 study of the drug demonstrated positive efficacy results as well as a favourable safety profile. The company is currently enrolling patients for its phase 3 NEAT trial which will assess the neurological effects of EryDex in patients with A-T.
Dirk Thye MD, chief executive officer and chief medical officer at Quince Therapeutics commented: “The granting of Fast Track status for EryDex System marks another important milestone in our endeavor to identify a beneficial therapeutic solution for patients with A-T. We have initiated our pivotal phase 3 NEAT clinical trial, which is being conducted in the US, UK, and the European Union.”
Betsy Goodfellow
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