4DMT Announces First Patients Enrolled in 4FRONT-1 Phase 3 Clinical Trial Evaluating 4D-150 in Wet AMD
4D Molecular Therapeutics (FDMT) has announced the enrollment of first patients in its 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for wet age-related macular degeneration (wet AMD) treatment. The trial is a multicenter, randomized, double-masked study comparing 4D-150 with aflibercept 2 mg.
The primary endpoint aims to demonstrate non-inferiority in mean change from baseline in best corrected visual acuity at 52 weeks. A key secondary endpoint focuses on reducing treatment burden by comparing the number of aflibercept injections between treatment arms.
The company plans to initiate 4FRONT-2, a second Phase 3 trial with identical design, in Q3 2025. Topline primary endpoint data from both trials is expected in the second half of 2027. The treatment aims to address the challenge of frequent eye injections while preserving eyesight for millions of wet AMD patients.
4D Molecular Therapeutics (FDMT) ha annunciato l'arruolamento dei primi pazienti nel suo 4FRONT-1 studio clinico di fase 3 che valuta 4D-150 per il trattamento della degenerazione maculare legata all'età umida (wet AMD). Lo studio è un trial multicentrico, randomizzato e in doppio cieco che confronta 4D-150 con aflibercept 2 mg.
L'obiettivo primario mira a dimostrare la non inferiorità nella variazione media dal basale della migliore acuità visiva corretta a 52 settimane. Un obiettivo secondario chiave si concentra sulla riduzione del carico di trattamento confrontando il numero di iniezioni di aflibercept tra i gruppi di trattamento.
L'azienda prevede di avviare 4FRONT-2, un secondo studio di fase 3 con design identico, nel terzo trimestre del 2025. I dati primari di sintesi da entrambi gli studi sono attesi nella seconda metà del 2027. Il trattamento mira ad affrontare la sfida delle frequenti iniezioni oculari preservando la vista per milioni di pazienti con wet AMD.
4D Molecular Therapeutics (FDMT) ha anunciado la inclusión de los primeros pacientes en su ensayo clínico de fase 3 4FRONT-1 que evalúa 4D-150 para el tratamiento de la degeneración macular relacionada con la edad húmeda (wet AMD). El ensayo es un estudio multicéntrico, aleatorizado y doble ciego que compara 4D-150 con aflibercept 2 mg.
El objetivo primario busca demostrar la no inferioridad en el cambio medio desde la línea base en la mejor agudeza visual corregida a las 52 semanas. Un objetivo secundario clave se centra en reducir la carga del tratamiento comparando el número de inyecciones de aflibercept entre los grupos de tratamiento.
La compañía planea iniciar 4FRONT-2, un segundo ensayo de fase 3 con un diseño idéntico, en el tercer trimestre de 2025. Se esperan los datos primarios de ambos ensayos para la segunda mitad de 2027. El tratamiento busca abordar el desafío de las frecuentes inyecciones oculares mientras preserva la visión para millones de pacientes con wet AMD.
4D Molecular Therapeutics (FDMT)는 습식 노인성 황반변성(wet AMD) 치료를 위한 4D-150의 4FRONT-1 3상 임상 시험에 첫 환자가 등록되었음을 발표했습니다. 이 시험은 4D-150과 2 mg의 아플리버셉트를 비교하는 다기관, 무작위, 이중 맹검 연구입니다.
주요 목표는 52주 후의 최적 교정 시력이 기준선에서의 평균 변화에서 비열등성을 입증하는 것입니다. 주요 2차 목표는 치료군 간의 아플리버셉트 주사 횟수를 비교하여 치료 부담을 줄이는 데 중점을 둡니다.
회사는 2025년 3분기에 동일한 설계의 두 번째 3상 시험인 4FRONT-2를 시작할 계획입니다. 두 시험의 주요 목표 데이터는 2027년 하반기에 예상됩니다. 이 치료는 잦은 안구 주사의 문제를 해결하면서 수백만 명의 습식 AMD 환자들의 시력을 보호하는 것을 목표로 합니다.
4D Molecular Therapeutics (FDMT) a annoncé l'inclusion des premiers patients dans son essai clinique de phase 3 4FRONT-1 évaluant 4D-150 pour le traitement de la dégénérescence maculaire liée à l'âge humide (wet AMD). L'essai est une étude multicentrique, randomisée et en double aveugle comparant 4D-150 à l'aflibercept 2 mg.
L'objectif principal vise à démontrer la non-infériorité du changement moyen par rapport à la ligne de base de la meilleure acuité visuelle corrigée à 52 semaines. Un objectif secondaire clé se concentre sur la réduction de la charge de traitement en comparant le nombre d'injections d'aflibercept entre les bras de traitement.
L'entreprise prévoit de lancer 4FRONT-2, un deuxième essai de phase 3 avec un design identique, au troisième trimestre 2025. Les données des objectifs primaires des deux essais sont attendues dans la seconde moitié de 2027. Le traitement vise à relever le défi des injections oculaires fréquentes tout en préservant la vue de millions de patients atteints de wet AMD.
4D Molecular Therapeutics (FDMT) hat die Rekrutierung der ersten Patienten für seine 4FRONT-1 Phase 3 klinische Studie zur Evaluierung von 4D-150 zur Behandlung der feuchten altersbedingten Makuladegeneration (wet AMD) bekannt gegeben. Die Studie ist eine multizentrische, randomisierte, doppelt verblindete Untersuchung, die 4D-150 mit Aflibercept 2 mg vergleicht.
Das primäre Ziel besteht darin, die Nichtunterlegenheit der durchschnittlichen Veränderung von der Ausgangslinie in der besten korrigierten Sehschärfe nach 52 Wochen zu demonstrieren. Ein wichtiges sekundäres Ziel konzentriert sich darauf, die Behandlungsbelastung zu reduzieren, indem die Anzahl der Aflibercept-Injektionen zwischen den Behandlungsgruppen verglichen wird.
Das Unternehmen plant, 4FRONT-2, eine zweite Phase 3 Studie mit identischem Design, im dritten Quartal 2025 zu starten. Die primären Endpunktdaten beider Studien werden für die zweite Hälfte von 2027 erwartet. Die Behandlung zielt darauf ab, die Herausforderung häufiger Augeninjektionen zu bewältigen und gleichzeitig das Augenlicht für Millionen von Patienten mit feuchter AMD zu erhalten.
- Advancement to Phase 3 clinical trials indicates significant progress in drug development
- Potential to reduce treatment burden from frequent eye injections to multi-year relief
- Two parallel Phase 3 trials (4FRONT-1 and 4FRONT-2) increase chances of successful approval
- Treatment addresses large market opportunity with millions of wet AMD patients
- Long wait for topline data (second half of 2027) may impact investor timeline
- Need to demonstrate non-inferiority against established treatment (aflibercept)
- Second Phase 3 trial hasn't started yet, scheduled for Q3 2025
Insights
4DMT's enrollment of first patients in its Phase 3 4FRONT-1 trial for 4D-150 marks a critical advancement in their clinical development program for wet age-related macular degeneration (wet AMD). This transition to Phase 3 status represents a significant milestone that substantially derisks the company's lead ophthalmology program.
The trial design focuses on demonstrating non-inferiority to aflibercept in visual acuity preservation while potentially reducing treatment burden - directly addressing the primary challenge in current wet AMD management: frequent intravitreal injections. The secondary endpoint measuring injection frequency reduction will be particularly important for commercial differentiation if successful.
From a strategic perspective, 4DMT is positioning 4D-150 as a potential backbone therapy in retinal diseases. The two-arm Phase 3 program (with 4FRONT-2 initiating in Q3 2025) demonstrates commitment to a robust data package for regulatory submission, though investors should note that topline results remain approximately 2.5 years away (H2 2027).
For a company with
The wet AMD market represents a multi-billion dollar opportunity with high unmet need for durable therapies. If 4D-150 can deliver on reducing treatment burden while maintaining efficacy, it could capture significant market share despite competitive programs in development across the industry.
EMERYVILLE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for the treatment of wet age-related macular degeneration (wet AMD).
"This is a historic moment for 4DMT as we become a Phase 3 company following our initiation of the 4FRONT-1 clinical trial,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “4D-150 has the clear potential to address the greatest unmet needs for the millions of patients with wet AMD and DME: multi-year relief from frequent and burdensome injections into the eye and preservation of their eyesight. We believe the design of the 4FRONT Phase 3 trials, the design of 4D-150 itself and the compelling clinical data generated to date position us for a successful product approval and commercialization. As a result of our innovation, 4D-150 has the potential to become the established durable backbone therapy for these diseases and to fit seamlessly into clinical practice and economic models for retina physicians.”
4FRONT-1 is a Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled study of intravitreal 4D-150 in wet AMD. The primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks. The key secondary endpoint is treatment burden reduction comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept comparator arm over 52 weeks. Patients in both arms will be eligible for supplemental aflibercept injections. 4FRONT-1 is evaluating treatment naïve wet AMD patients at sites in North America. Our second Phase 3 trial for wet AMD, 4FRONT-2, has an identical design to 4FRONT-1 but will evaluate 4D-150 in both treatment naïve and recently diagnosed, treatment experienced wet AMD patients globally. 4FRONT-2 is expected to initiate in Q3 2025. Topline primary endpoint data from both trials is expected in the second half of 2027.
"Our patients with wet AMD currently face the burden of frequent, life-long bolus intravitreal injections, which negatively impacts quality of life not only for the patients themselves but also for their families and caregivers,” said Fuad Makkouk, M.D., a principal investigator of the 4FRONT-1 clinical trial. “From the promising data we've seen so far, 4D-150 has the potential to revolutionize the patient experience and provide a meaningful improvement in the lives of people living with wet AMD."
"As an investigator in the PRISM Phase 1/2 study with 4D-150, I’ve had the opportunity to see firsthand its potential to alter the course of the disease and reduce the treatment burden for patients with wet AMD," said Arshad M. Khanani, M.D., M.A., FASRS, Chair of the 4DMT Ophthalmology Advisory Board and a principal investigator of the 4FRONT-1 clinical trial. "I’m thrilled to participate in the 4FRONT-1 trial and look forward to collaborating with the dedicated team at 4DMT and my fellow investigators to potentially bring 4D-150 to patients with wet AMD, with the chance to make a lasting difference in their lives."
About 4D-150
4D-150 is a potential backbone therapy that is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. 4D-150 utilizes our customized and evolved intravitreal vector, R100, which was invented at 4DMT through our proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and diabetic macular edema, which both affect millions of patients globally, with the goal of relieving patients from burdensome injections while preserving vision.
About Wet AMD
Wet AMD is a highly prevalent disease, with more than 4 million individuals expected to be affected in the next five years in certain major markets, including the U.S., the EU and Japan. The disease also has a high incidence, with 200,000 individuals estimated to be newly diagnosed every year in the U.S. alone. Wet AMD is a type of macular degeneration in which abnormal blood vessels grow into the macula (macular neovascularization or MNV), the central area of the retina. MNV causes swelling and edema of the retina, bleeding and scarring, leading to visual distortion and reduced visual acuity. The proliferation and leakage of abnormal blood vessels is stimulated by VEGF. This process distorts and, without treatment, can potentially destroy central vision and may progress to blindness.
About 4DMT
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. Our lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. Our lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. Our second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.
All of our product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of our product candidates for the therapeutic uses for which they are being studied.
Learn more at www.4DMT.com and follow us on LinkedIn.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development, regulatory interactions, and potential commercialization of our product candidates, including 4D-150. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Annual Report on Form 10-K, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Contacts:
Media:
Jenn Gordon
dna Communications
Media@4DMT.com
Investors:
Julian Pei
Head of Investor Relations and Corporate Finance
Investor.Relations@4DMT.com
FAQ
What is the primary endpoint of FDMT's 4FRONT-1 Phase 3 trial for wet AMD?
When will FDMT release topline data for the 4FRONT Phase 3 trials?
How does FDMT's 4D-150 aim to improve wet AMD treatment?
What is the difference between FDMT's 4FRONT-1 and 4FRONT-2 trials?
When will FDMT begin the 4FRONT-2 Phase 3 trial for wet AMD?
