Quince Therapeutics to Host Investor Webinar Today Focused on Addressing the High Unmet Need in Ataxia-Telangiectasia
Quince Therapeutics (NASDAQ: QNCX) announced significant progress in its Phase 3 NEAT clinical trial for Ataxia-Telangiectasia (A-T), with enrollment nearing 50%. The company has enrolled 46 participants to date, including 40 in the primary analysis population of six to nine-year-olds, with plans to enroll approximately 86 patients in this age group and 20 patients aged 10 or older.
The NEAT trial is being conducted under a Special Protocol Assessment agreement with the FDA, evaluating EryDex (dexamethasone sodium phosphate encapsulated in autologous red blood cells) for A-T treatment. The company expects to complete enrollment in Q2 2025 and report topline results in Q4 2025.
An open-label extension has been initiated with 17 participants enrolled across the U.S., U.K., and European Union. Pending positive results, Quince plans to submit a New Drug Application to the FDA and a Marketing Authorization Application to the EMA in 2026.
Quince Therapeutics (NASDAQ: QNCX) ha annunciato progressi significativi nel suo studio clinico di fase 3 NEAT per l'Atassia-Telangiectasia (A-T), con l'arruolamento che si avvicina al 50%. L'azienda ha arruolato finora 46 partecipanti, di cui 40 nella popolazione principale di analisi composta da bambini di età compresa tra sei e nove anni, con piani per arruolare circa 86 pazienti in questo gruppo di età e 20 pazienti di 10 anni o più.
Il trial NEAT è condotto sotto un accordo di Valutazione del Protocollo Speciale con la FDA, valutando EryDex (fosfato sodico di desametasone incapsulato in globuli rossi autologhi) per il trattamento dell'A-T. L'azienda si aspetta di completare l'arruolamento nel secondo trimestre del 2025 e di riportare i risultati principali nel quarto trimestre del 2025.
È stata avviata un'estensione in aperto con 17 partecipanti arruolati negli Stati Uniti, nel Regno Unito e nell'Unione Europea. In attesa di risultati positivi, Quince prevede di presentare una Domanda per un Nuovo Farmaco alla FDA e una Domanda di Autorizzazione alla Commercializzazione all'EMA nel 2026.
Quince Therapeutics (NASDAQ: QNCX) anunció avances significativos en su ensayo clínico de fase 3 NEAT para la Ataxia-Telangiectasia (A-T), con la inscripción acercándose al 50%. Hasta la fecha, la compañía ha inscrito a 46 participantes, incluidos 40 en la población de análisis principal de niños de seis a nueve años, con planes de inscribir aproximadamente 86 pacientes en este grupo de edad y 20 pacientes de 10 años o más.
El ensayo NEAT se está llevando a cabo bajo un acuerdo de Evaluación de Protocolo Especial con la FDA, evaluando EryDex (fósfato de sodio de dexametasona encapsulado en glóbulos rojos autólogos) para el tratamiento de la A-T. La compañía espera completar la inscripción en el segundo trimestre de 2025 y reportar los resultados generales en el cuarto trimestre de 2025.
Se ha iniciado una extensión de etiquetado abierto con 17 participantes inscritos en EE. UU., Reino Unido y la Unión Europea. Pendiente de resultados positivos, Quince planea presentar una Solicitud de Nuevo Medicamento a la FDA y una Solicitud de Autorización de Comercialización a la EMA en 2026.
Quince Therapeutics (NASDAQ: QNCX)는 운동 실조증-모세혈관 확장증(A-T)에 대한 3상 NEAT 임상 시험이 50%에 가까운 모집 진전을 보였다고 발표했습니다. 현재까지 46명의 참가자가 등록되었으며, 이 중 6세에서 9세 사이의 주요 분석 대상자 40명이 포함되어 있으며, 이 연령대에서 약 86명의 환자와 10세 이상의 20명의 환자를 등록할 계획입니다.
NEAT 시험은 FDA와의 특별 프로토콜 평가 협정에 따라 진행되며, 운동 실조증 치료를 위해 EryDex(자가 적혈구 내에 캡슐화된 인산 나트륨 덱사메타손)를 평가하고 있습니다. 이 회사는 2025년 2분기까지 등록을 마치고 2025년 4분기에는 주요 결과를 보고할 것으로 기대하고 있습니다.
미국, 영국 및 유럽 연합에서 17명의 참가자가 등록된 공개 연장 연구가 시작되었습니다. 긍정적인 결과가 나오면 Quince는 2026년에 FDA에 신규 의약품 신청서와 EMA에 마케팅 승인 신청서를 제출할 계획입니다.
Quince Therapeutics (NASDAQ: QNCX) a annoncé des progrès significatifs dans son essai clinique de phase 3 NEAT pour l'Ataxie-Telangiectasie (A-T), avec un recrutement atteignant près de 50 %. À ce jour, la société a recruté 46 participants, dont 40 dans la population d'analyse principale des enfants âgés de six à neuf ans, avec des plans pour recruter environ 86 patients dans ce groupe d'âge et 20 patients âgés de 10 ans ou plus.
L'essai NEAT est mené dans le cadre d'un accord d'évaluation de protocole spécial avec la FDA, évaluant EryDex (phosphate de dexaméthasone sodique encapsulé dans des globules rouges autologues) pour le traitement de l'A-T. La société s'attend à finaliser le recrutement au T2 2025 et à publier les résultats principaux au T4 2025.
Une extension à étiquetage ouvert a été initiée avec 17 participants recrutés aux États-Unis, au Royaume-Uni et dans l'Union Européenne. En cas de résultats positifs, Quince prévoit de soumettre une demande de nouveau médicament à la FDA et une demande d'autorisation de mise sur le marché à l'EMA en 2026.
Quince Therapeutics (NASDAQ: QNCX) hat bedeutende Fortschritte in seiner Phase-3-NEAT-Studie zur Ataxie-Telangiektasie (A-T) bekanntgegeben, wobei die Einschreibung fast 50 % erreicht hat. Das Unternehmen hat bis heute 46 Teilnehmer eingeschrieben, darunter 40 in der Hauptanalysestichprobe von sechs bis neun Jahren, mit dem Ziel, etwa 86 Patienten in dieser Altersgruppe und 20 Patienten im Alter von 10 Jahren oder älter einzuschreiben.
Die NEAT-Studie wird im Rahmen einer Vereinbarung zur speziellen Protokollbewertung mit der FDA durchgeführt, die EryDex (Natriumphosphat-Dexamethason, das in autologen roten Blutkörperchen eingekapselt ist) zur Behandlung von A-T bewertet. Das Unternehmen erwartet, die Einschreibung im zweiten Quartal 2025 abzuschließen und im vierten Quartal 2025 die Gesamtergebnisse zu berichten.
Eine offene Verlängerung wurde mit 17 Teilnehmern in den USA, Großbritannien und der Europäischen Union eingeleitet. Bei positiven Ergebnissen plant Quince, im Jahr 2026 einen Antrag auf Zulassung eines neuen Arzneimittels bei der FDA und einen Antrag auf Marktzulassung bei der EMA einzureichen.
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Phase 3 NEAT clinical trial nearing
Quince also disclosed that the company has enrolled 46 participants to date in its pivotal Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T; NCT06193200 / IEDAT-04-2022) clinical trial to evaluate the neurological effects of EryDex in patients with A-T.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, “We continue to make significant progress with clinical site activations and enrollment of our pivotal Phase 3 NEAT clinical trial. With 61 participants screened to date, enrollment is nearing
Pivotal Phase 3 NEAT Clinical Trial
- Enrolled 46 participants to date in the company’s Phase 3 NEAT clinical trial to evaluate the neurological effects of EryDex in patients with A-T, including 40 participants in the six to nine year-old primary analysis population. Quince 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.
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Open label extension initiated with 17 participants rolling over to date in the
U.S. ,U.K. , and European Union. Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to an open label extension study. -
Pivotal Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the
U.S. Food and Drug Administration (FDA). - Expect to report Phase 3 NEAT topline results in the fourth quarter of 2025 with a New Drug Application (NDA) submission to the FDA and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) in 2026, assuming positive study results.
- NEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, EryDex (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells), in patients with A-T.
- Participants will be randomized (1:1) between EryDex or placebo and treatment will consist of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in a rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo as per the SPA agreement with the FDA.
Join Today’s A-T KOL Investor Webinar
Quince will host an investor webinar today focused on addressing the high unmet need in the company’s lead rare pediatric neurodegenerative disease indication, Ataxia-Telangiectasia (A-T), today, Friday, February 7, 2025, beginning at 10:00 a.m. Eastern Time.
The webinar will feature leading A-T KOL Mary Kay Koenig, M.D., who will: 1) provide an A-T natural history overview, 2) detail current symptomatic treatment approaches for patients with A-T, 3) discuss the competitive therapeutic A-T landscape, and 4) provide an overview of Quince’s Phase 3 clinical trial of EryDex for the treatment of A-T. Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will join the discussion to provide a corporate and scientific overview, as well as an enrollment update on the company’s ongoing Phase 3 NEAT clinical trial.
Mary Kay Koenig, M.D., is a board certified child neurologist specializing in neurodegenerative disorders, including A-T, mitochondrial disease, and tuberous sclerosis complex. She currently serves as a Professor and Associate Vice-Chair for Clinical Research in the Department of Pediatrics, Division of Child and Adolescent Neurology at the McGovern Medical School at the University of
To register for this webinar, please click here. A live webcast of the presentation will be accessible on Quince’s Events page under the News & Events heading of the company’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.
About Quince Therapeutics
Quince Therapeutics, Inc. (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 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 the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll, conduct, and/or complete current and additional studies; current and future clinical development of EryDex, including for the potential treatment of Ataxia-Telangiectasia (A-T) and other potential indications; the strategic development path for EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of EryDex 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 November 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/20250207587017/en/
Media & Investor Contact:
Stacy Roughan
Quince Therapeutics, Inc.
Vice President, Corporate Communications & Investor Relations
ir@quincetx.com
Source: Quince Therapeutics, Inc.
FAQ
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