Opthea Announces Completion of Drug Substance PPQ Campaign Validating Manufacturing Process of Sozinibercept
Opthea (ASX/NASDAQ: OPT) has successfully completed its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, a potential treatment for wet age-related macular degeneration (wet AMD). The campaign involved producing three consecutive commercial-scale drug substance batches, validating Opthea's manufacturing process. This achievement is a significant milestone towards a potential Biologics License Application (BLA) filing for sozinibercept in wet AMD.
CEO Fred Guerard emphasized that this success demonstrates the company's ability to consistently manufacture quality drug substance at commercial scale, a important component for the BLA Chemistry, Manufacturing and Controls (CMC) module. Opthea is now well-positioned to supply its planned drug product PPQ campaign and initial launch materials. A progress update on the drug product PPQ campaign is expected in early 2025.
Opthea (ASX/NASDAQ: OPT) ha completato con successo la sua campagna di Qualificazione delle Prestazioni del Processo (PPQ) per sozinibercept, un potenziale trattamento per la degenerazione maculare legata all'età umida (wet AMD). La campagna ha comportato la produzione di tre lotti consecutivi di sostanza farmaceutica su scala commerciale, validando il processo di produzione di Opthea. Questo risultato rappresenta un traguardo significativo verso una potenziale Domanda di Licenza per Biologici (BLA) per sozinibercept nella wet AMD.
Il CEO Fred Guerard ha sottolineato che questo successo dimostra la capacità dell'azienda di produrre costantemente sostanze farmaceutiche di qualità su scala commerciale, un componente importante per il modulo di Chimica, Produzione e Controllo (CMC) della BLA. Opthea è ora ben posizionata per fornire la sua pianificata campagna di PPQ del prodotto farmaceutico e i materiali per il lancio iniziale. Un aggiornamento sui progressi della campagna PPQ del prodotto farmaceutico è previsto per all'inizio del 2025.
Opthea (ASX/NASDAQ: OPT) ha completado exitosamente su campaña de Calificación de Desempeño del Proceso (PPQ) para sozinibercept, un tratamiento potencial para la degeneración macular relacionada con la edad húmeda (wet AMD). La campaña involucró la producción de tres lotes consecutivos de sustancia farmacéutica a escala comercial, validando el proceso de fabricación de Opthea. Este logro representa un hito significativo hacia una posible Solicitud de Licencia Biológica (BLA) para sozinibercept en wet AMD.
El CEO Fred Guerard enfatizó que este éxito demuestra la capacidad de la empresa para fabricar de manera consistente sustancia farmacéutica de calidad a escala comercial, un componente importante para el módulo de Química, Fabricación y Control (CMC) de la BLA. Opthea ahora está bien posicionada para suministrar su campaña planificada de PPQ del producto farmacéutico y los materiales de lanzamiento inicial. Se espera una actualización sobre el progreso de la campaña PPQ del producto farmacéutico a principios de 2025.
Opthea (ASX/NASDAQ: OPT)는 습성 노인성 황반변성(wet AMD)의 잠재적 치료제인 소지니버셉트에 대한 약물 물질 프로세스 성능 자격(PPQ) 캠페인을 성공적으로 완료했습니다. 이 캠페인은 세 개의 연속 상업 규모 약물 물질 배치를 생산하고 Opthea의 제조 프로세스를 검증하는 것을 포함했습니다. 이 성과는 소지니버셉트를 위한 잠재적인 생물학적 라이센스 신청(BLA) 제출을 향한 중요한 이정표입니다.
CEO인 Fred Guerard는 이 성공이 회사가 상업 규모에서 일관되게 고품질 약물 물질을 제조할 수 있는 능력을 보여준다고 강조했습니다. 이는 BLA 화학, 제조 및 통제(CMC) 모듈에 중요한 요소입니다. Opthea는 이제 계획된 약물 제품 PPQ 캠페인과 초기 출시 자료를 공급할 수 있는 좋은 위치에 있습니다. 약물 제품 PPQ 캠페인에 대한 진행 상황 업데이트는 2025년 초에 예상됩니다.
Opthea (ASX/NASDAQ: OPT) a terminé avec succès sa campagne de Qualification de Performance du Processus (PPQ) pour le sozinibercept, un traitement potentiel de la dégénérescence maculaire liée à l'âge humide (wet AMD). La campagne a impliqué la production de trois lots consécutifs de substance médicamenteuse à échelle commerciale, validant ainsi le processus de fabrication d'Opthea. Cette réalisation constitue une étape significative vers une éventuelle Demande de Licence Biologique (BLA) pour le sozinibercept dans le cadre de la wet AMD.
Le PDG Fred Guerard a souligné que ce succès démontre la capacité de l'entreprise à fabriquer de manière cohérente des substances médicamenteuses de qualité à l'échelle commerciale, un élément important pour le module de Chimie, Fabrication et Contrôle (CMC) de la BLA. Opthea est maintenant bien positionnée pour fournir sa campagne prévue de PPQ pour le produit médicamenteux ainsi que les matériaux de lancement initiaux. Une mise à jour sur les progrès de la campagne PPQ pour le produit médicamenteux est attendue au début de 2025.
Opthea (ASX/NASDAQ: OPT) hat erfolgreich seine Kampagne zur Prozessleistungsqualifizierung (PPQ) für Soziniberzept abgeschlossen, eine potenzielle Behandlung für die feuchte altersbedingte Makuladegeneration (wet AMD). Die Kampagne umfasste die Produktion von drei aufeinanderfolgenden Chargen an Arzneimittelstoffen im kommerziellen Maßstab, wodurch der Herstellungsprozess von Opthea validiert wurde. Dieser Erfolg stellt einen wichtigen Meilenstein auf dem Weg zu einer möglichen Biologics License Application (BLA) für Soziniberzept bei wet AMD dar.
CEO Fred Guerard betonte, dass dieser Erfolg die Fähigkeit des Unternehmens demonstriert, konstant qualitativ hochwertige Arzneimittelstoffe im kommerziellen Maßstab herzustellen, was ein wichtiger Bestandteil für das Modul Chemie, Herstellung und Kontrolle (CMC) der BLA ist. Opthea ist nun gut positioniert, um seine geplante Kampagne zur PPQ des Arzneimittelprodukts sowie die Materialien für den Erststart zu liefern. Ein Fortschrittsupdate zur PPQ-Kampagne des Arzneimittelprodukts wird Anfang 2025 erwartet.
- Successful completion of drug substance PPQ campaign for sozinibercept
- Validation of manufacturing process at commercial scale
- Major milestone achieved towards potential BLA filing for wet AMD treatment
- Demonstrated ability to consistently produce quality drug substance
- Well-positioned to supply drug product PPQ campaign and initial launch materials
- None.
Insights
The successful completion of the drug substance PPQ campaign for sozinibercept is a significant milestone in Opthea's journey towards commercialization. This achievement demonstrates the company's ability to consistently produce high-quality, commercial-scale batches of the drug substance, which is important for regulatory approval and market launch.
The validation of the manufacturing process through three consecutive successful batches is a critical component of the CMC module for the potential BLA filing. This progress significantly de-risks the program from a manufacturing perspective, potentially streamlining the regulatory review process. However, investors should note that while this is a positive step, it does not guarantee FDA approval, as clinical efficacy and safety data from the ongoing Phase 3 trials will be equally important.
Sozinibercept's development for wet AMD treatment is noteworthy in the ophthalmology field. The completion of the drug substance PPQ campaign suggests that Opthea is making steady progress towards potentially bringing a new therapy to market. Wet AMD is a leading cause of vision loss in older adults and new treatment options are always welcome.
The fact that Opthea has two fully enrolled Phase 3 trials ongoing is promising, as it indicates the company is in the final stages of clinical development. If sozinibercept demonstrates efficacy and safety in these trials and with the manufacturing process now validated, it could potentially offer a new alternative for patients who may not respond well to current treatments. However, it's important to await the clinical trial results before drawing conclusions about the drug's potential impact on wet AMD treatment landscape.
Opthea's progress with sozinibercept is strategically significant. The completion of the drug substance PPQ campaign not only validates their manufacturing capabilities but also positions the company for potential market entry. This milestone, combined with the ongoing Phase 3 trials, suggests Opthea is nearing the final stages of development for sozinibercept in wet AMD.
Investors should consider that while this news is positive, several critical steps remain, including the completion of clinical trials, the drug product PPQ campaign and the actual BLA submission and review. The timeline for the drug product PPQ update in early 2025 indicates that market launch, if approved, is still some time away. Nevertheless, Opthea's progress in manufacturing readiness could potentially accelerate the path to commercialization if clinical trials yield positive results, potentially improving the company's competitive position in the ophthalmology market.
Three consecutive commercial-scale batches successfully produced
Major milestone for potential BLA filing of sozinibercept in wet AMD
Progress update of drug product PPQ campaign expected in early 2025
MELBOURNE, Australia and PRINCETON, N.J., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept. The PPQ campaign consisted of the production of three successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process. The batches have been produced following an extensive manufacturing process development program.
“The successful completion of the drug substance PPQ campaign is an important step towards de-risking the program and a potential biologics license application (BLA) filing of sozinibercept in wet AMD,” commented Fred Guerard, PharmD, Chief Executive Officer of Opthea. “While we continue to advance our two fully enrolled, pivotal Phase 3 trials of sozinibercept in wet AMD, we now have demonstrated our ability to consistently manufacture quality drug substance at commercial scale, which will serve as a key component of our BLA Chemistry, Manufacturing and Controls (CMC) module.”
“In achieving this commercialization milestone, we believe Opthea is well positioned to supply both our planned drug product PPQ campaign, as well as our initial launch materials,” concluded Mark O’Neill, Vice President, Technical Operations, Opthea. “We expect to share a progress update of our drug product PPQ campaign in early 2025.”
About Opthea
Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Opthea’s lead product candidate, sozinibercept, is being evaluated in two fully enrolled pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents.
To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn.
Forward Looking Statements
This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding the Company’s continued efforts to advance its BLA preparations for FDA approval, the Company’s commercialization potential and timing of the progress update of the Company’s drug product PPQ campaign. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept safety, tolerability and therapeutic efficacy, clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 30, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law.
Authorized for release to ASX by Frederic Guerard, CEO
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FAQ
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