STOCK TITAN

4DMT to Host 4D-150 Wet AMD Development Day on September 18, 2024

Rhea-AI Impact
(Low)
Rhea-AI Sentiment
(Neutral)
Tags
conferences

4D Molecular Therapeutics (Nasdaq: FDMT) is set to host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET. The event will showcase the company's product development strategy for 4D-150 and present Phase 1/2 PRISM clinical trial data in wet age-related macular degeneration (wet AMD), including the longest available interim follow-up data.

The agenda includes presentations on the 4D-150 Phase 1/2 development strategy, featuring details on clinical trial design, treatment cohorts, and study objectives. Data presentation will cover interim follow-up results from various cohorts and dose levels, with efficacy data focusing on supplemental aflibercept injections, Best Corrected Visual Acuity (BCVA), and Central Subfield Thickness (CST). The event will also provide an overview of the 4FRONT Phase 3 clinical trial program in wet AMD.

A KOL panel featuring renowned retinal disease experts will participate in discussions and a live Q&A session alongside senior company leadership.

4D Molecular Therapeutics (Nasdaq: FDMT) organizzerà un evento dal titolo Giornata di Sviluppo 4D-150 per AMD Umida il 18 settembre 2024 alle 16:15 ET. L'evento presenterà la strategia di sviluppo dei prodotti dell'azienda per 4D-150 e mostrerà i dati del trial clinico di Fase 1/2 PRISM per la degenerazione maculare legata all'età (AMD umida), compresi i dati di follow-up intermedio più lunghi disponibili.

L'agenda include presentazioni sulla strategia di sviluppo per la Fase 1/2 di 4D-150, con dettagli sulla progettazione del trial clinico, le coorti di trattamento e gli obiettivi dello studio. La presentazione dei dati coprirà i risultati di follow-up intermedi provenienti da diverse coorti e livelli di dosaggio, con i dati di efficacia focalizzati sulle iniezioni supplementari di aflibercept, sulla Migliore Acuità Visiva Correttamente (BCVA) e sullo Spessore del Sottocampo Centrale (CST). L'evento offrirà anche una panoramica del programma di trial clinico di Fase 3 di 4FRONT per AMD umida.

Un panel di KOL composto da esperti rinomati in malattie retiniche parteciperà a discussioni e a una sessione di domande e risposte in diretta insieme ai dirigenti senior dell'azienda.

4D Molecular Therapeutics (Nasdaq: FDMT) organizará un evento titulado Día de Desarrollo 4D-150 para AMD Húmeda el 18 de septiembre de 2024 a las 4:15 p.m. ET. El evento mostrará la estrategia de desarrollo de productos de la compañía para 4D-150 y presentará los datos del ensayo clínico de Fase 1/2 PRISM en degeneración macular asociada a la edad (AMD húmeda), incluyendo los datos de seguimiento intermedios más prolongados disponibles.

La agenda incluye presentaciones sobre la estrategia de desarrollo de Fase 1/2 de 4D-150, con detalles sobre el diseño del ensayo clínico, las cohortes de tratamiento y los objetivos del estudio. La presentación de datos abarcará los resultados de seguimiento intermedios de diversas cohortes y niveles de dosis, centrándose en los datos de eficacia relacionados con inyecciones suplementarias de aflibercept, la Mejor Agudeza Visual Corregida (BCVA) y el Espesor del Subcampo Central (CST). El evento también proporcionará una visión general del programa de ensayo clínico de Fase 3 de 4FRONT en AMD húmeda.

Un panel de KOL compuesto por expertos renombrados en enfermedades retinianas participará en discusiones y en una sesión de preguntas y respuestas en vivo junto a la alta dirección de la empresa.

4D 분자 치료제 (Nasdaq: FDMT)4D-150 습식 AMD 개발의 날2024년 9월 18일 오후 4시 15분 ET에 개최할 예정입니다. 이 행사에서는 4D-150의 제품 개발 전략을 소개하고, 습기와 관련된 세포의 변성(습식 AMD)에 대한 1/2상 PRISM 임상 시험 데이터를 발표하며, 사용 가능한 가장 긴 중간 추적 데이터도 포함됩니다.

일정에는 4D-150 1/2상 개발 전략에 대한 발표가 포함되어 있으며, 임상 시험 설계, 치료 집단, 연구 목표에 대한 세부 정보가 제공됩니다. 데이터 발표에는 다양한 집단과 용량 수준에서의 중간 추적 결과가 포함되며, 효능 데이터는 보조 아플리버셉트 주사, 수정된 최종 시각적 예리도(BCVA) 및 중앙 하위 영역 두께(CST)에 중점을 둡니다. 또한 본 행사는 습식 AMD에 대한 4FRONT 3상 임상 시험 프로그램의 개요도 제공할 예정입니다.

저명한 망막 질환 전문가들로 구성된 KOL 패널이 논의 및 고위 기업 리더십과 함께하는 라이브 Q&A 세션에 참여합니다.

4D Molecular Therapeutics (Nasdaq: FDMT) organisera une Journée de Développement 4D-150 pour l'AMD Humide le 18 septembre 2024 à 16h15 ET. Cet événement mettra en avant la stratégie de développement de produits de l'entreprise pour 4D-150 et présentera les données de l'essai clinique de Phase 1/2 PRISM sur la dégénérescence maculaire liée à l'âge (AMD humide), y compris les données de suivi intérimaires les plus longues disponibles.

L'agenda comprend des présentations sur la stratégie de développement de 4D-150 en Phase 1/2, avec des détails sur la conception de l'essai clinique, les cohortes de traitement et les objectifs de l'étude. La présentation des données portera sur les résultats d'un suivi intérimaire provenant de différentes cohortes et niveaux de dosage, avec des données d'efficacité se concentrant sur les injections supplémentaires d'aflibercept, l'Acuité Visuelle Corrigée Maximale (BCVA) et l'Épaisseur du Sous-Domaine Central (CST). L'événement offrira également un aperçu du programme d'essai clinique de Phase 3 de 4FRONT dans l'AMD humide.

Un panel de KOL composé d'experts renommés en maladies rétiniennes participera à des discussions et à une session de questions-réponses en direct avec la direction de l'entreprise.

4D Molecular Therapeutics (Nasdaq: FDMT) wird am 18. September 2024 um 16:15 Uhr ET einen Entwicklungstag für 4D-150 bei feuchter AMD veranstalten. Die Veranstaltung wird die Produktentwicklungsstrategie des Unternehmens für 4D-150 präsentieren und die Daten der klinischen Phase 1/2 PRISM-Studie zur feuchten altersbedingten Makuladegeneration (feuchte AMD) zeigen, einschließlich der längsten verfügbaren interimsdaten.

Die Agenda umfasst Präsentationen zur Entwicklungsstrategie der Phase 1/2 für 4D-150, einschließlich Details zum Studiendesign, den Behandlungsgruppen und den Studienzielen. Die Datenpräsentation wird zwischenzeitliche Ergebnisse aus verschiedenen Gruppen und Dosierungslevels abdecken, wobei die Wirksamkeitsdaten den Schwerpunkt auf ergänzende Aflibercept-Injektionen, die Beste Korrigierte Sehschärfe (BCVA) und die Dicke des zentralen Unterfeldes (CST) legen. Die Veranstaltung bietet auch einen Überblick über das Phase 3-Programms von 4FRONT bei feuchter AMD.

Ein KOL-Panel, bestehend aus renommierten Experten für Netzhauterkrankungen, wird an Diskussionen und einer Live-Q&A-Sitzung mit der Unternehmensführung teilnehmen.

Positive
  • None.
Negative
  • None.
  • Company to highlight 4D-150 product development strategy and Phase 1/2 PRISM clinical trial data in wet age-related macular degeneration (wet AMD), including longest available interim follow-up data
  • Overview of the 4FRONT Phase 3 clinical trial program in wet AMD
  • Corporate webcast to be held on September 18, 2024 at 4:15 p.m. ET and followed by live Q&A with senior Company leadership and retinal disease key opinion leader (KOL) panel, including Arshad M. Khanani, M.D., M.A., FASRS, Carl D. Regillo, M.D., FACS, FASRS, and Dante Pieramici, M.D.

EMERYVILLE, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that the Company will host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET.

The 4D-150 Wet AMD Development Day agenda will feature presentations, KOL panel discussions and live Q&A with senior ophthalmology Company leadership, including Robert Kim, M.D. (Chief Medical Officer), Dhaval Desai, Pharm.D. (Chief Development Officer), Chris Simms (Chief Commercial Officer) and Carlos Quezada-Ruiz, M.D., FASRS (SVP, Therapeutic Area Head, Ophthalmology) and retinal disease KOLs Arshad M. Khanani, M.D., M.A., FASRS (Sierra Eye Associates), Carl D. Regillo, M.D., FACS, FASRS (Wills Eye Hospital) and Dante Pieramici, M.D. (California Retina Consultants).

The agenda will include presentations on:

  • Overview of 4D-150 Phase 1/2 Development Strategy in Wet AMD to Date (PRISM Clinical Trial):
    • Rationale for clinical trial design and treatment cohorts
    • Phase 1/2a Study Design (Dose Exploration / Expansion cohorts)
      • Primary Objectives: Demonstrate safety profile, evidence of biological activity and selection of Phase 2b doses
      • Patient Population: Severe disease activity, high treatment burden (minimum 6 prior injections in last 12 months) and generally long disease duration
      • Aflibercept loading dose regimen design: Given heavy pre-treatment of patients on study, single loading dose given at Week -1
    • Phase 2b Study Design (Population Extension cohort)
      • Primary Objective: Confirm safety & evidence of biological activity in broad patient population, select Phase 3 dose and patient population to maximize probability of technical, regulatory and commercial success
      • Patient Population: Broad range of disease activity, prior treatment burden (1 to 6 prior injections in last 12 months) and disease duration
      • Aflibercept loading dose design: Given only 1 prior injection required, loading doses given at weeks -1 & 4 to ensure all patients receive 3 total loading injections per standard of care, and to maintain patient safety during ramp up of aflibercept transgene expression over 8-12 weeks
  • Expected Data Presentation & Analyses:
    • Presentation of interim longest available follow-up data for below cohorts and dose levels from PRISM based on August 26, 2024 data cutoff
      • Follow-up Duration
        • Phase 1/2a (Dose Exploration / Expansion cohorts; 6E9, 1E10 and 3E10 vg/eye of 4D-150 and aflibercept control arms), range of follow-up: 52 weeks to 2.5 years
        • Phase 2b (Population Extension cohort; 1E10 and 3E10 vg/eye arms), range of follow-up: 32 to 52 weeks
      • Efficacy Data
        • Supplemental aflibercept injections
        • Best Corrected Visual Acuity (BCVA)
        • Central Subfield Thickness (CST)
        • Subgroup analyses based on:
          • CST <600 μm
          • Disease duration
          • Number of prior injections
          • Approximate target Phase 3 population
      • Safety Data
  • Review of 4FRONT Wet AMD Phase 3 Program Objectives, Strategy and Final Design

About the KOL Panelists

  • Arshad M. Khanani, M.D., M.A., FASRS, is a Managing Partner, Director of Clinical Research and Director of Fellowship at Sierra Eye Associates, and Clinical Professor at the University of Nevada, Reno School of Medicine. He has served as the principal investigator for more than 120 clinical trials and has over 150 scientific publications. Dr. Khanani is an elected member of the Macula Society and Retina Society. He has received numerous awards of distinction including the prestigious American Society of Retina Specialists (ASRS) Presidents’ Young Investigator Award and the ASRS Presidential Award. He is the lead Principal Investigator of the 4D-150 PRISM clinical trial and the Chair of 4DMT’s Ophthalmology Advisory Board.
  • Carl D. Regillo, M.D., FACS, FASRS, is the Director of the Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia. He is the founder and former Director of the Wills Eye Clinical Retina Research Unit, former Chairman of the American Academy of Ophthalmology Retina Basic and Clinical Science Course, former Chairman of the Wills Eye Institutional Review Board, and prior Director of the Wills Eye Retina Fellowship. Dr. Regillo has authored over 200 publications along with over 50 book chapters and nine major books. He has been an investigator on numerous major clinical trials developing new treatments for retinal disorders such as macular degeneration and diabetic retinopathy. He lectures worldwide and has served on the scientific editorial board for numerous publications.
  • Dante Pieramici, M.D., is a Managing Partner at California Retina Consultants, President of the California Retina Research Foundation, a member of the Medical Leadership Board of the Retina Consultants of America. Currently, he is the Medical Director of Clinical Research at California Retina Consultants. Dr. Pieramici has served as the principal, sub, reading center investigator or advisor for over 100 clinical trials. His research has focused primarily on new surgical and pharmacologic treatments for age-related macular degeneration and diabetic-related eye diseases. He is a Principal Investigator of the 4D-150 PRISM clinical trial and member of 4DMT’s Ophthalmology Advisory Board.

4D-150 Wet AMD Development Day Webcast Details

Title:4D-150 Wet AMD Development Day
Date/Time:Wednesday, September 18, 2024 from 4:15 p.m. to 6:15 p.m. ET
Registration:Link
 

An archived copy of the webcast will be available for up to one year by visiting the “Investors & Media” section of the 4DMT website: https://ir.4dmoleculartherapeutics.com/events.

About 4DMT

4DMT is a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases in ophthalmology and pulmonology. 4DMT’s proprietary invention platform, Therapeutic Vector Evolution, combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors for use in our wholly owned and partnered product candidates. Our product design, development, and manufacturing engine helps us efficiently create and advance our diverse product pipeline with the goal of revolutionizing medicine with potential curative therapies for millions of patients. Currently, 4DMT is advancing six clinical-stage and one preclinical product candidate, each tailored to address rare and large market diseases in ophthalmology, pulmonology and cardiology. In addition, 4DMT is also advancing programs in CNS through a gene editing partnership. 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 (FDA) 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 of and regulatory interactions regarding 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 Quarterly Report on Form 10-Q to be filed on or about the date hereof, 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:

Katherine Smith
Inizio Evoke Comms
Media@4DMT.com

Investors:

Julian Pei
Head of Investor Relations and Corporate Finance
Investor.Relations@4DMT.com


FAQ

When is 4DMT hosting its 4D-150 Wet AMD Development Day?

4D Molecular Therapeutics (FDMT) is hosting its 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET.

What clinical trial data will be presented at the 4DMT Development Day?

The event will present Phase 1/2 PRISM clinical trial data for 4D-150 in wet age-related macular degeneration (wet AMD), including the longest available interim follow-up data.

What are the main objectives of the 4D-150 Phase 1/2a study in wet AMD?

The primary objectives of the Phase 1/2a study are to demonstrate the safety profile of 4D-150, provide evidence of biological activity, and select doses for the Phase 2b trial.

What patient population is included in the 4D-150 Phase 2b study for wet AMD?

The Phase 2b study includes a broad range of patients with varying disease activity, prior treatment burden (1 to 6 prior injections in last 12 months), and disease duration.

What efficacy data will be presented for 4D-150 in wet AMD at the Development Day?

Efficacy data to be presented includes supplemental aflibercept injections, Best Corrected Visual Acuity (BCVA), Central Subfield Thickness (CST), and subgroup analyses based on various factors.

4D Molecular Therapeutics, Inc.

NASDAQ:FDMT

FDMT Rankings

FDMT Latest News

FDMT Stock Data

470.58M
51.97M
3.48%
112.37%
18.36%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States of America
EMERYVILLE