FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex
California-based biotech Quince Therapeutics has won fast track designation from the US Food and Drug Administration (FDA) for its ataxia-telangiectasia (A-T) drug EryDex.
According to the 3 June announcement, fast track designation was awarded to address a high unmet medical need for patients with A-T. The status allows for earlier interactions with the FDA as Quince seeks accelerated approval, and also the possibility to undergo rolling reviews.
A-T is a rare disease of the nervous and immune systems, affecting motor movement and speech. EryDex utilises autologous intracellular drug encapsulation (AIDE) technology to administer dexamethasone sodium phosphate (DSP) into a patient’s red blood cells. Red blood cells filled with DSP are then reinfused into the patient, allowing for the slow release of steroids over several weeks, without the long-term toxicity commonly associated with chronic administration.
The FDA lifted a partial clinical hold that was on the drug in October 2023, advancing it into the Phase III NEAT study (NCT06193200). The FDA removed the partial clinical hold after requesting additional information on plastics used in the single-use EryKit, which is part of EryDex. Changes were made to comply with recent European regulations.
Quince shared in an April 2024 business update that it anticipates topline results in H2 2025 with a potential NDA submission in 2026.
Quince inherited EryDex in July 2023 when it acquired biotech EryDel in a $485m deal in October 2023. Formerly known as Cortexyme, Quince changed its name in 2022 and focused on rare diseases following several setbacks, including a clinical hold on its Alzheimer’s disease drug atuzaginstat.
About EryDex for A-T
EryDex is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells. DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. EryDex is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment.
June 5, 2024
