Quince Therapeutics (Nasdaq: QNCX) announced significant progress in its pivotal Phase 3 NEAT clinical trial, reaching nearly 50% enrollment in its study of EryDex for treating Ataxia-Telangiectasia (A-T), a rare pediatric neurodegenerative disease.
The company has successfully enrolled 46 participants to date, including 40 patients within the critical six to nine-year-old primary analysis population. The trial, operating under a Special Protocol Assessment (SPA) agreement with the FDA, aims to evaluate the neurological effects of EryDex, which consists of dexamethasone sodium phosphate encapsulated in autologous red blood cells.
"We continue to make significant progress with clinical site activations and enrollment of our pivotal Phase 3 NEAT clinical trial," stated Dr. Dirk Thye, Chief Executive Officer and Chief Medical Officer of Quince. "With 61 participants screened to date, enrollment is nearing 50% and we expect screening and randomization to accelerate in the coming weeks due to several new geographic regions and sites scheduled for activation."
Trial Design and Objectives
The NEAT trial (NCT06193200) is designed as an international, multi-center, randomized, double-blind, placebo-controlled study. The protocol calls for:
- Total enrollment target of approximately 106 patients
- 86 patients aged 6-9 years (primary analysis population)
- 20 patients aged 10 years or older
- 1:1 randomization between EryDex and placebo
- Treatment schedule of six infusions every 21-30 days
The primary efficacy endpoint will measure changes from baseline using a rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo, as specified in the FDA SPA agreement.
Open Label Extension Progress
In a significant development, the company has initiated an open-label extension study, with 17 participants already transitioning from the main trial across the U.S., U.K., and European Union. This extension provides continued access to treatment for eligible participants who complete the initial study period and consent to further participation.
Regulatory Timeline
Assuming positive study results, Quince has outlined its regulatory strategy:
- Topline results expected in Q4 2025
- New Drug Application (NDA) submission to FDA planned for 2026
- Marketing Authorization Application (MAA) submission to European Medicines Agency (EMA) scheduled for 2026
The company is positioning EryDex to address the significant unmet medical need in A-T treatment, with the potential to become a groundbreaking therapy for this rare neurodegenerative condition. The trial's progress represents a crucial step forward in developing targeted treatments for A-T patients, who currently have limited therapeutic options.
