Quince Therapeutics Presents Data from Prior Phase 3 ATTeST Clinical Trial at 2024 International Congress for Ataxia Research
Quince Therapeutics (Nasdaq: QNCX) presented data from its Phase 3 ATTeST clinical trial at the 2024 International Congress for Ataxia Research. The trial evaluated EryDex for treating Ataxia-Telangiectasia (A-T). Key findings showed that 24-month EryDex treatment didn't adversely affect growth and bone mineral density in A-T patients, comparing favorably to natural disease progression. The study also identified that mICARS and RmICARS measures best reflect disease progression in A-T patients aged 6-10 years. Quince is currently conducting a pivotal Phase 3 NEAT trial under FDA Special Protocol Assessment, with topline results expected in Q4 2025.
Quince Therapeutics (Nasdaq: QNCX) ha presentato dati dal suo trial clinico di Fase 3 ATTeST al Congresso Internazionale per la Ricerca sull'Atassia del 2024. Il trial ha valutato EryDex per il trattamento dell'Atassia-Telangiectasia (A-T). I risultati principali hanno mostrato che il trattamento con EryDex per 24 mesi non ha avuto effetti negativi sulla crescita e sulla densità minerale ossea nei pazienti con A-T, confrontandosi favorevolmente con la progressione naturale della malattia. Lo studio ha anche identificato che le misure mICARS e RmICARS riflettono meglio la progressione della malattia nei pazienti A-T di età compresa tra 6 e 10 anni. Attualmente, Quince sta conducendo uno studio pivotale di Fase 3 NEAT sotto la Valutazione del Protocollo Speciale della FDA, con risultati preliminari attesi nel quarto trimestre del 2025.
Quince Therapeutics (Nasdaq: QNCX) presentó datos de su ensayo clínico de Fase 3 ATTeST en el Congreso Internacional para la Investigación de la Ataxia 2024. El ensayo evaluó EryDex para el tratamiento de la Ataxia-Telangiectasia (A-T). Los hallazgos clave mostraron que el tratamiento con EryDex durante 24 meses no afectó negativamente el crecimiento y la densidad mineral ósea en pacientes con A-T, comparándose favorablemente con la progresión natural de la enfermedad. El estudio también identificó que las medidas mICARS y RmICARS reflejan mejor la progresión de la enfermedad en pacientes A-T de 6 a 10 años. Actualmente, Quince está llevando a cabo un ensayo pivotal de Fase 3 NEAT bajo la Evaluación de Protocolo Especial de la FDA, con resultados preliminares esperados para el cuarto trimestre de 2025.
퀸스 테라퓨틱스 (Nasdaq: QNCX)는 2024 국제 운동 실조증 연구 회의에서 3상 ATTeST 임상 시험의 데이터를 발표했습니다. 이 시험은 EryDex가 운동 실조증-모세혈관 확장증(A-T) 치료에 대한 평가를 했습니다. 주요 발견에 따르면 24개월 동안의 EryDex 치료는 A-T 환자의 성장과 뼈 미네랄 밀도에 부정적인 영향을 미치지 않았으며, 자연적인 질병 진행과 비교해 유리한 결과를 보였습니다. 이 연구는 또한 6세에서 10세 사이의 A-T 환자에서 mICARS와 RmICARS 측정이 질병 진행을 가장 잘 반영한다는 것을 확인했습니다. 현재 퀸스는 FDA 특별 프로토콜 평가 하에 중요한 3상 NEAT 시험을 진행하고 있으며, 주요 결과는 2025년 4분기에 예상됩니다.
Quince Therapeutics (Nasdaq: QNCX) a présenté des données de son essai clinique de Phase 3 ATTeST lors du Congrès international de la recherche sur l'ataxie en 2024. L'essai a évalué EryDex pour le traitement de l'ataxie-télangiectasie (A-T). Les résultats clés ont montré que le traitement par EryDex sur 24 mois n'a pas eu d'effet négatif sur la croissance et la densité minérale osseuse chez les patients A-T, se comparant favorablement à la progression naturelle de la maladie. L'étude a également identifié que les mesures mICARS et RmICARS reflètent le mieux la progression de la maladie chez les patients A-T âgés de 6 à 10 ans. Actuellement, Quince mène un essai pivot de Phase 3 NEAT sous l'évaluation du protocole spécial de la FDA, avec des résultats préliminaires attendus au quatrième trimestre 2025.
Quince Therapeutics (Nasdaq: QNCX) präsentierte Daten aus seiner Phase-3-Studie ATTeST auf dem Internationalen Kongress für Ataxieforschung 2024. In der Studie wurde EryDex zur Behandlung der Ataxie-Telangiektasie (A-T) bewertet. Die wichtigsten Ergebnisse zeigten, dass die Behandlung mit EryDex über 24 Monate das Wachstum und die Knochendichte bei A-T-Patienten nicht negativ beeinflusste und sich vorteilhaft im Vergleich zum natürlichen Krankheitsverlauf verhielt. Die Studie identifizierte auch, dass die Maße mICARS und RmICARS die Krankheitsprogression bei A-T-Patienten im Alter von 6 bis 10 Jahren am besten widerspiegeln. Quince führt derzeit eine entscheidende Phase-3-Studie NEAT unter der speziellen Protokollbewertung der FDA durch, und die Ergebnisse werden im vierten Quartal 2025 erwartet.
- EryDex demonstrated strong safety profile with no adverse effects on growth and bone density
- Currently enrolling Phase 3 NEAT trial under FDA Special Protocol Assessment
- Received FDA Fast Track designation for EryDex System
- Potential NDA and MAA submissions planned for 2026
- None.
Insights
This presentation of Phase 3 ATTeST trial data reveals promising safety findings for EryDex in treating Ataxia-Telangiectasia (A-T). The key highlights show that 24-month EryDex treatment did not cause typical corticosteroid-related side effects on growth and bone density - a significant advantage over traditional steroid treatments. The analysis also validated the modified ICARS scoring system as an effective measure of disease progression, particularly in 6-10 year old patients.
The ongoing Phase 3 NEAT trial, operating under an FDA Special Protocol Assessment with Fast Track designation, targets enrollment of 86 primary analysis patients aged 6-9 years. With
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “We continue to gain valuable insights from the robust dataset provided from our prior Phase ATTeST clinical trial, which is the largest study of patients with A-T completed to date. We are pleased to share new analyses of these data at the 2024 International Congress for Ataxia Research that showcase EryDex’s strong safety profile and provide validation of the primary efficacy endpoint utilized in our study of EryDex for the treatment of A-T.”
The objective of the poster titled Growth and Bone Mineral Density (BMD) in Children with Ataxia-Telangiectasia (A-T) Treated with Intra-Erythrocyte Dexamethasone (EryDex) for 24 months describes growth and bone mineral density in patients with A-T treated for 24 months with EryDex. Key findings reported in the poster presentation include:
- 24 months of EryDex treatment did not adversely affect growth and bone mineral density of patients with A-T.
- Results compare favorably to natural history of patients with A-T who experience height and weight faltering, in addition to abnormal bone mineral density.
- No weight gain, adverse growth, or bone health typically associated with the use of corticosteroids in children were observed.
The objective of the poster titled Cross-sectional Analysis of International Cooperative Ataxia Rating Scale (ICARS) Subcomponent Scores in Children with Ataxia-Telangiectasia (A-T) describes the baseline ICARS subcomponent scores by age in a cross-sectional analysis of treatment-naive patients from the ATTeST dataset and identifies ICARS subcomponents that best reflect progression of disease by age. Key findings reported in the poster presentation include:
- ICARS subcomponents in the mICARS (modified International Cooperative Ataxia Rating Scale) and RmICARS (Rescored modified International Cooperative Ataxia Rating Scale) analyses capture the fastest neurological symptom progression in patients with A-T between the ages of six to 10 year olds who were ambulatory at baseline.
- Posture and gait category of ICARS showed progression with age in untreated patients with A-T between the ages of six and 10 years old.
- Scales with reduced kinetic function domain may be more sensitive than full ICARS scores when assessing disease progression over shorter periods of time in younger children.
- mICARS and RmICARS measures focus on assessment of the participant’s posture and gait as opposed to kinetic function and speech.
- mICARS and RmICARS subcomponents of ICARS best reflect progression of disease by age and capture the fastest neurological symptom progression in patients with A-T between the ages of six to 10 years.
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 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 novel 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 a 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112415817/en/
Media & Investor Contact:
Stacy Roughan
Quince Therapeutics, Inc.
Vice President, Corporate Communications & Investor Relations
ir@quincetx.com
Source: Quince Therapeutics, Inc.
FAQ
What were the key findings of Quince Therapeutics (QNCX) Phase 3 ATTeST trial for EryDex?
When will Quince Therapeutics (QNCX) report Phase 3 NEAT trial results?
How many patients will be enrolled in Quince Therapeutics (QNCX) Phase 3 NEAT trial?
