Adverum Biotechnologies Announces Completion of Screening for Pivotal Phase 3 ARTEMIS Trial of Ixo-vec for Wet Age-Related Macular Degeneration
Adverum Biotechnologies (NASDAQ:ADVM) announced accelerated progress in its pivotal Phase 3 ARTEMIS trial for Ixo-vec, a potential one-time gene therapy treatment for wet age-related macular degeneration (wet AMD). The company will complete patient screening by September 30, 2025, ahead of schedule.
The trial is expected to achieve full enrollment of at least 284 patients in Q4 2025, earlier than the previous target of Q1 2026. This acceleration has moved the topline data readout forward to Q1 2027. ARTEMIS is comparing a single administration of Ixo-vec (6E10 vg/eye) to aflibercept (2mg) given every 8 weeks in both treatment-naïve and previously treated patients.
Adverum Biotechnologies (NASDAQ:ADVM) ha annunciato progressi accelerati nel suo studio pivotal di Fase 3 ARTEMIS per Ixo-vec, una potenziale terapia genica a dose unica per la degenerazione maculare legata all’età umida (wet AMD). L’azienda completerà lo screening dei pazienti entro il 30 settembre 2025, in anticipo rispetto al programma previsto.
Lo studio prevede di raggiungere l’iscrizione completa di almeno 284 pazienti nel Q4 2025, prima dell’obiettivo precedente del Q1 2026. Questa accelerazione ha spostato la lettura dei dati topline a Q1 2027. ARTEMIS confronta una singola somministrazione di Ixo-vec (6E10 vg/occhio) con l’aflibercept (2 mg) somministrato ogni 8 settimane sia in pazienti naïve al trattamento sia in quelli già trattati.
Adverum Biotechnologies (NASDAQ:ADVM) anunció avances acelerados en su ensayo pivotal de Fase 3 ARTEMIS para Ixo-vec, una potencial terapia génica de dosis única para la degeneración macular relacionada con la edad húmeda (DMAE húmeda). la empresa completará el cribado de pacientes para el 30 de septiembre de 2025, con anticipación.
Se espera que el ensayo alcance la inscripción completa de al menos 284 pacientes en el Q4 de 2025, antes del objetivo anterior de Q1 de 2026. Esta aceleración ha adelantado la lectura de datos topline a Q1 2027. ARTEMIS compara una única administración de Ixo-vec (6E10 vg/ojo) con aflibercept (2 mg) administrado cada 8 semanas, tanto en pacientes naïve al tratamiento como en los previamente tratados.
Adverum Biotechnologies (NASDAQ:ADVM)은 황반변성(wet AMD) 관련 질환에 대한 단일 용량 유전자 치료제 가능성으로 간주되는 Ixo-vec의 결정적 3상 ARTEMIS 임상에서 가속 진행을 발표했다. 회사는 2025년 9월 30일까지 환자 선별을 완료할 예정이며 일정에 앞당겨 진행 중이다.
시험은 2025년 4분기까지 최소 284명의 환자 전체 등록을 달성할 것으로 예상되며, 이전 목표였던 2026년 1분기보다 앞당겨졌다. 이 가속으로 topline 데이터 발표는 2027년 1분기로 앞당겨졌다. ARTEMIS은 Ixo-vec의 단일 투여(6E10 vg/eye)를 매 8주마다 투여하는 aflibercept(2 mg)와 비교하며, 치료 초기 환자와 이전에 치료를 받은 환자 모두를 대상으로 한다.
Adverum Biotechnologies (NASDAQ:ADVM) a annoncé des progrès accélérés dans son essai pivot de Phase 3 ARTEMIS pour Ixo-vec, une éventuelle thérapie génique à dose unique pour la DMLA humide (wet AMD). L’entreprise assurera le dépistage des patients d’ici le 30 septembre 2025, en avance sur le calendrier.
L’essai devrait atteindre l’inscription complète d’au moins 284 patients au T4 2025, plus tôt que l’objectif précédent du T1 2026. Cette accélération a déplacé la lecture des données topline vers le T1 2027. ARTEMIS compare une administration unique d’Ixo-vec (6E10 vg/oeil) à l’aflibercept (2 mg) administré toutes les 8 semaines, chez des patients naïfs de traitement ainsi que chez ceux déjà traités.
Adverum Biotechnologies (NASDAQ:ADVM) gab bekannt, dass es im pivotalen Phase-3-Studie ARTEMIS für Ixo-vec beschleunigte Fortschritte gibt, einer potenziellen Einmal-Gentherapie-Behandlung bei feuchter altersbedingter Makuladegeneration (wet AMD). Das Unternehmen wird das Patientenscreening bis zum 30. September 2025 abschließen, und zwar früher als geplant.
Die Studie wird voraussichtlich die vollständige Einschreibung von mindestens 284 Patienten im Q4 2025 erreichen, früher als das frühere Ziel Q1 2026. Diese Beschleunigung hat die topline-Datenauswertung auf Q1 2027 vorgezogen. ARTEMIS vergleicht eine einmalige Verabreichung von Ixo-vec (6E10 vg/Auge) mit Afibercept (2 mg), das alle 8 Wochen verabreicht wird, sowohl bei therapienaiven als auch bei zuvor behandelten Patienten.
Adverum Biotechnologies (NASDAQ:ADVM) أعلنت تقدمًا متسارعًا في تجربتها المحورية المرحلة 3 ARTEMIS لدواء Ixo-vec، وهو علاج جيني محتمل بجرعة واحدة لعلاج التنكس البقعي المرتبط بالعمر الرطب (wet AMD). ستكمل الشركة فحص المرضى بحلول 30 سبتمبر 2025، قبل الجدول الزمني المحدد.
يتوقع أن يحقق الاختبار التعيين الكامل لـ ما لا يقل عن 284 مريضًا في الربع الرابع من 2025، وهو مبكر عما كان مخططًا سابقًا للربع الأول من 2026. هذا التعجيل حرك قراءة البيانات الأولية إلى الربع الأول من 2027. تقارن ARTEMIS بين إدارة وحيدة لـ Ixo-vec (6E10 vg/eye) مع الأفليبرسابت (2 mg) التي تُعطى كل 8 أسابيع في كل من المرضى الذين لم يتلقوا علاجًا من قبل والمرضى السابق علاجهم.
Adverum Biotechnologies (NASDAQ:ADVM) 宣布在其关键性<3期ARTEMIS试验中取得加速进展，针对 Ixo-vec 这一可能的一次性基因治疗用于湿性年龄相关性黄斑变性（wet AMD）。公司将于<2025年9月30日前完成患者筛选，领先于计划进度。
试验预计在2025年第四季度实现至少284名患者的全部入组，早于先前的2026年第一季度目标。此次加速将 topline 数据读取时间提前至2027年第一季度。ARTEMIS 将比较单次给药的 Ixo-vec（6E10 vg/眼）与阿弗琼塞普特（aflibercept，2 mg）每8周给药，在治疗初治患者和既往治疗患者之间进行比较。
- None.
- Phase 3 results still pending with no efficacy data available yet
- Competition from established wet AMD treatments like aflibercept continues
- Screening closing ahead of expectations, with full enrollment now anticipated in 4Q 2025 (previously 1Q 2026)
- ARTEMIS topline data readout accelerated to 1Q 2027
REDWOOD CITY, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of intravitreal gene therapy as a potential One And DoneTM treatment to preserve sight for life, today announced it has notified sites that it plans to complete screening in ARTEMIS, its first pivotal Phase 3 trial evaluating Ixo-vec in wet age-related macular degeneration (wet AMD) by September 30, seven months after initiation, because the company now expects full enrollment of at least 284 treatment-naïve and treatment experienced patients in 4Q 2025 and data readout in 1Q 2027.
ARTEMIS is the first of two Phase 3 registrational trials for Ixo-vec in wet AMD, evaluating a single administration of Ixo-vec (6E10 vg/eye) compared to aflibercept (2mg) every 8 weeks in both treatment-naïve and previously treated patients. Information about the trial is available at www.clinicaltrials.gov (ARTEMIS identifier: NCT06856577).
About Ixo-vec in Wet AMD
Adverum is developing ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), its clinical-stage gene therapy product candidate, for the treatment of wet AMD. Ixo-vec utilizes a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require surgery to administer the gene therapy under the retina (sub-retinal approach), Ixo-vec is designed to be administered as a one-time IVT injection in the physician’s office, deliver long-term efficacy, reduce the burden of frequent anti-VEGF, optimize patient compliance and improve vision outcomes for patients with wet AMD. In recognition of the need for new treatment options for wet AMD, FDA granted Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations for Ixo-vec for the treatment of wet AMD. Ixo-vec has also received PRIME designation from the EMA and the Innovation Passport from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for the treatment of wet AMD.
About Adverum Biotechnologies
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the capabilities of its proprietary intravitreal platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. Additionally, by overcoming the challenges associated with current treatment paradigms for debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. For more information, please visit www.adverum.com.
Forward-looking Statements
Statements contained in this press release regarding events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding: the therapeutic and commercial potential of Ixo-vec, including its potential to be One-And-Done therapy for wet AMD patients; the anticipated completion of screening, enrollment and announcement of the topline data results for the ARTEMIS Phase 3 trial; and other statements that are not a historical fact. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverum’s novel technology, which makes it difficult to predict the timing of commencement and completion of clinical trials; regulatory uncertainties; enrollment uncertainties; the results of early clinical trials not always being predictive of future clinical trials and results; the potential for future complications or side effects in connection with use of Ixo-vec; Adverum’s ability to continue as a going concern and improve its financial position; and risks associated with market conditions. Additional risks and uncertainties facing Adverum are set forth under the caption “Risk Factors” and elsewhere in Adverum’s Securities and Exchange Commission (SEC) filings and reports, including Adverum’s most recent Quarterly Report on Form 10‑Q filed with the SEC on August 12, 2025 and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Corporate & Investor Inquiries:
Adverum Investor Relations
Email: ir@adverum.com
Media:
Jason Awe, Ph.D.
Executive Director, Corporate Communications
Email: jawe@adverum.com
FAQ
When will Adverum's Phase 3 ARTEMIS trial for Ixo-vec complete enrollment?
What is the purpose of Adverum's ARTEMIS Phase 3 trial for wet AMD?
When will Adverum (ADVM) release topline data for the ARTEMIS trial?
How many patients will be enrolled in Adverum's Phase 3 ARTEMIS trial?
What makes Ixo-vec different from current wet AMD treatments?
