Quince Therapeutics Presents Safety Data from Prior Phase 3 ATTeST Clinical Trial at 53rd Child Neurology Society Annual Meeting
Quince Therapeutics (Nasdaq: QNCX) presented safety data from its Phase 3 ATTeST clinical trial at the 53rd Child Neurology Society Annual Meeting. The trial evaluated EryDex (intra-erythrocyte dexamethasone sodium phosphate) in Ataxia-Telangiectasia (A-T) patients. Results showed EryDex was generally well-tolerated with mostly mild to moderate side effects. The company is currently conducting a pivotal Phase 3 NEAT trial, expecting to enroll 86 patients aged 6-9 years and 20 patients aged 10+ years. Topline results are expected in Q4 2025, with potential FDA and EMA submissions in 2026.
Quince Therapeutics (Nasdaq: QNCX) ha presentato dati di sicurezza del suo studio clinico di fase 3 ATTeST durante il 53° Meeting Annuale della Child Neurology Society. Lo studio ha valutato EryDex (dexametazone sodico intra-eritrocitario) in pazienti con Atassia-Teleangectasia (A-T). I risultati hanno mostrato che EryDex è stato generalmente ben tollerato, con effetti collaterali per lo più lievi o moderati. L'azienda sta attualmente conducendo un trial cruciale di fase 3, chiamato NEAT, previsto per arruolare 86 pazienti di età compresa tra 6 e 9 anni e 20 pazienti di età pari o superiore a 10 anni. I risultati principali sono attesi nel quarto trimestre del 2025, con possibili sottomissioni alla FDA e all'EMA nel 2026.
Quince Therapeutics (Nasdaq: QNCX) presentó datos de seguridad de su ensayo clínico de fase 3 ATTeST en la 53ª Reunión Anual de la Sociedad de Neurología Infantil. El ensayo evaluó EryDex (fósfato sódico de dexametasona intra-eritrocitaria) en pacientes con Ataxia-Telangiectasia (A-T). Los resultados mostraron que EryDex fue generalmente bien tolerado, con efectos secundarios principalmente leves a moderados. La compañía está llevando a cabo actualmente un estudio pivote de fase 3, llamado NEAT, y espera reclutar a 86 pacientes de entre 6 y 9 años y a 20 pacientes de 10 años o más. Se esperan resultados preliminares en el cuarto trimestre de 2025, con posibles presentaciones a la FDA y la EMA en 2026.
퀸스 테라퓨틱스 (Nasdaq: QNCX)는 제53회 아동 신경학회 연례 회의에서 3상 ATTeST 임상 시험의 안전성 데이터를 발표했습니다. 이 시험은 아탤락시아-겸상혈관확장증(A-T) 환자에서 에리덱스 (적혈구 내 덱사메타손 나트륨 인산염)를 평가했습니다. 결과는 에리덱스가 주로 경증에서 중등도의 부작용을 동반하며 대체로 잘 견딜 수 있음을 보여주었습니다. 이 회사는 현재 6-9세 환자 86명과 10세 이상 환자 20명을 등록할 계획인 중요한 3상 NEAT 시험을 진행 중입니다. 주요 결과는 2025년 4분기에 발표될 예정이며, 2026년에는 FDA와 EMA에 제출할 가능성도 있습니다.
Quince Therapeutics (Nasdaq: QNCX) a présenté des données de sécurité de son essai clinique de phase 3 ATTeST lors de la 53e Réunion Annuelle de la Société de Neurologie Pédiatrique. L'essai a évalué EryDex (phosphate de dexaméthasone intra-érythrocytaire) chez des patients atteints d'Ataxie-Télangiectasie (A-T). Les résultats ont montré qu'EryDex était généralement bien toléré, avec principalement des effets secondaires légers à modérés. L'entreprise mène actuellement un essai pivot de phase 3, appelé NEAT, dont elle prévoit de recruter 86 patients âgés de 6 à 9 ans et 20 patients de 10 ans et plus. Les résultats préliminaires sont attendus au quatrième trimestre 2025, avec des soumissions potentielles à la FDA et à l'EMA en 2026.
Quince Therapeutics (Nasdaq: QNCX) präsentierte Sicherheitsdaten aus seiner Phase-3-Studie ATTeST auf dem 53. Jahresmeeting der Child Neurology Society. Die Studie bewertete EryDex (intrazelluläres Dexamethason-Natriumphosphat) bei Patienten mit Ataxie-Telangiektasie (A-T). Die Ergebnisse zeigten, dass EryDex im Allgemeinen gut vertragen wurde, mit überwiegend milden bis moderaten Nebenwirkungen. Das Unternehmen führt derzeit eine entscheidende Phase-3-Studie, NEAT, durch, die voraussichtlich 86 Patienten im Alter von 6-9 Jahren und 20 Patienten ab 10 Jahren rekrutieren wird. Die wichtigsten Ergebnisse werden für das vierte Quartal 2025 erwartet, mit möglichen Einreichungen bei der FDA und EMA im Jahr 2026.
- EryDex demonstrated favorable safety profile with mostly mild to moderate side effects
- No typical chronic steroid use side effects observed
- FDA granted Fast Track designation for EryDex System
- Special Protocol Assessment (SPA) agreement secured with FDA for Phase 3 NEAT trial
- Three patients discontinued from the study due to adverse events
- One serious adverse event of B-cell lymphoma reported
- Two patients in high-dose group experienced treatment-related adverse events
Insights
The ATTeST trial safety data for EryDex demonstrates a favorable safety profile, marking a significant milestone for Quince Therapeutics' rare disease treatment pipeline. The key safety findings show minimal serious adverse events and absence of typical steroid-related side effects, which is particularly noteworthy for a chronic treatment.
The ongoing pivotal Phase 3 NEAT trial, operating under an FDA Special Protocol Assessment, represents a important value inflection point. With topline results expected in Q4 2025 and potential regulatory submissions in 2026, this positions QNCX for a potential market entry in a high-unmet-need indication. The Fast Track designation further validates the program's importance and could accelerate the regulatory timeline.
The well-defined patient population (ages 6-9 for primary analysis) and robust trial design with 86 patients provides clear regulatory pathway. The expansion to include 20 additional older patients demonstrates potential for broader market opportunity.
Key findings reported in the poster presentation, titled Treatment-Emergent Adverse Events (TEAEs) in Children With Ataxia-Telangiectasia Treated for One Year With Intra-Erythrocyte Dexamethasone Sodium Phosphate (EryDex), include:
- EryDex treatment was generally well tolerated with most TEAEs being mild to moderate and transient, and generally similar between EryDex- and placebo-treated patients.
- Side effects typically attributed to chronic steroid use, such as Cushingoid features, hyperglycemia, hirsutism, or hypertension, were not observed.
- Three patients were discontinued from the study: one patient in the low-dose group had a serious adverse event (SAE) of B-cell lymphoma (unlikely treatment related) and two patients in the high-dose group had TEAEs of pyrexia and tachycardia (one patient, probably treatment related) and pain and pruritus (one patient, possibly treatment related).
- There were no TEAEs leading to death.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “Results from the ATTeST study, including the emerging safety profile of intra-erythrocyte dexamethasone treatment, suggest that EryDex may be a promising therapy for patients with A-T and should be further evaluated for potential investigational treatment for patients requiring chronic steroid use. We are pleased to advance EryDex treatment in our pivotal Phase 3 NEAT study, currently enrolling patients with A-T in the
Pivotal Phase 3 NEAT Clinical Trial
Quince is currently enrolling a pivotal Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T; #IEDAT-04-2022/NCT06193200) clinical trial, which is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the neurological effects of EryDex treatment in patients with A-T. The company plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older.
The Phase 3 NEAT trial is being conducted under a Special Protocol Assessment (SPA) agreement with the
About Ataxia-Telangiectasia
A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the
About EryDex for A-T
The EryDex System is a drug/device combination product comprised of dexamethasone sodium phosphate (DSP) which is encapsulated and administered using a patient’s own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The EryDex System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment.
EryDex leverages Quince’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology platform that uses an automated process designed to encapsulate and administer a drug using the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response.
About Quince Therapeutics
Quince Therapeutics (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince Therapeutics on social media platforms LinkedIn, Facebook, X, and YouTube.
Forward-looking Statements
Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to current and future clinical development of EryDex, including for the potential treatment of Ataxia-Telangiectasia (A-T) and other potential indications, related development and commercial-stage inflection point for EryDex, the company’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology for treatment of other rare diseases; the strategic development path for EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; the timing and success of the clinical trials and related data, including plans and the ability to initiate, fund, enroll, conduct, and/or complete current and additional studies; the company’s future development plans and related timing; the company’s focus, objectives, plans, and strategies; and the potential benefits of EryDex, AIDE technology and the company’s market opportunity. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 13, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
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Media & Investor Contact:
Stacy Roughan
Quince Therapeutics, Inc.
Vice President, Corporate Communications & Investor Relations
ir@quincetx.com
Source: Quince Therapeutics, Inc.
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