Citius Pharmaceuticals Reports Productive FDA Type C Meeting to Discuss Phase 3 Mino-Lok® Program and Pathway to Approval
Citius Pharmaceuticals announced a productive Type C meeting with the FDA following the successful completion of their Phase 3 clinical trial for Mino-Lok®. The meeting focused on discussing clinical trial data and establishing a pathway for future New Drug Application (NDA) submission. The FDA provided clear and actionable guidance regarding the novel catheter lock solution designed to salvage central venous catheters in patients with bloodstream infections. The company reports that Mino-Lok® demonstrated compelling clinical outcomes in Phase 3, potentially offering an alternative to catheter removal that could reduce healthcare costs and improve patient outcomes.
Citius Pharmaceuticals ha annunciato un produttivo incontro di Tipo C con la FDA in seguito al completamento con successo del loro trial clinico di Fase 3 per Mino-Lok®. L'incontro si è concentrato sulla discussione dei dati del trial clinico e sull'istituzione di un percorso per la futura presentazione della Domanda di Nuovo Medicinale (NDA). La FDA ha fornito linee guida chiare e attuabili riguardo alla nuova soluzione di lock per cateteri progettata per salvare i cateteri venosi centrali in pazienti con infezioni del flusso sanguigno. L'azienda riporta che Mino-Lok® ha dimostrato risultati clinici convincenti nella Fase 3, offrendo potenzialmente un'alternativa alla rimozione del catetere, con la possibilità di ridurre i costi sanitari e migliorare i risultati per i pazienti.
Citius Pharmaceuticals anunció una productiva reunión de Tipo C con la FDA tras la finalización exitosa de su ensayo clínico de Fase 3 para Mino-Lok®. La reunión se centró en discutir los datos del ensayo clínico y establecer una vía para la futura presentación de la Solicitud de Nuevo Medicamento (NDA). La FDA proporcionó orientación clara y accionable sobre la nueva solución de cierre de catéteres diseñada para salvaguardar los catéteres venosos centrales en pacientes con infecciones en el torrente sanguíneo. La empresa informa que Mino-Lok® demostró resultados clínicos convincentes en la Fase 3, lo que podría ofrecer una alternativa a la extracción del catéter que podría reducir los costos de atención médica y mejorar los resultados para los pacientes.
Citius Pharmaceuticals는 Mino-Lok®의 3상 임상 시험을 성공적으로 완료한 후 FDA와의 생산적인 타입 C 회의를 발표했습니다. 이 회의는 임상 시험 데이터를 논의하고 향후 신약 신청(NDA) 제출을 위한 경로를 설정하는 데 중점을 두었습니다. FDA는 혈류 감염 환자의 중앙 정맥 카테터를 구하기 위해 설계된 새로운 카테터 락 솔루션에 대한 명확하고 실행 가능한 지침을 제공했습니다. 회사는 Mino-Lok®이 3상에서 설득력 있는 임상 결과를 보여주었으며, 이는 카테터 제거에 대한 대안을 제공하고 의료 비용을 줄이며 환자 결과를 개선할 수 있는 가능성이 있다고 보고했습니다.
Citius Pharmaceuticals a annoncé une réunion de Type C productive avec la FDA suite à l'achèvement réussi de leur essai clinique de Phase 3 pour Mino-Lok®. La réunion a été axée sur la discussion des données d'essai clinique et l'établissement d'un chemin pour la future soumission d'une Demande de Nouveau Médicament (NDA). La FDA a fourni des conseils clairs et réalisables concernant la nouvelle solution de verrouillage de cathéter conçue pour sauver les cathéters veineux centraux chez les patients atteints d'infections du sang. L'entreprise rapporte que Mino-Lok® a démontré des résultats cliniques convaincants en Phase 3, offrant potentiellement une alternative au retrait du cathéter pouvant réduire les coûts de santé et améliorer les résultats pour les patients.
Citius Pharmaceuticals gab bekannt, dass ein produktives Typ-C-Meeting mit der FDA nach dem erfolgreichen Abschluss ihrer Phase-3-Studie für Mino-Lok® stattfand. In dem Meeting lag der Fokus auf der Diskussion der Studiendaten und der Festlegung eines Wegs für die zukünftige Einreichung eines Antrags auf Zulassung neuer Arzneimittel (NDA). Die FDA gab klare und umsetzbare Hinweise zu der neuartigen Katheter-Sperrlösung, die dazu dient, zentrale venöse Katheter bei Patienten mit Blutstrominfektionen zu retten. Das Unternehmen berichtet, dass Mino-Lok® in der Phase 3 überzeugende klinische Ergebnisse gezeigt hat, was möglicherweise eine Alternative zur Katheterentfernung bietet, die die Gesundheitskosten senken und die Patientenergebnisse verbessern könnte.
- Successful completion of Phase 3 clinical trial for Mino-Lok®
- Constructive FDA guidance received for NDA pathway
- Compelling clinical outcomes demonstrated in Phase 3 trial
- None.
Insights
The FDA Type C meeting for Mino-Lok represents a significant milestone in the regulatory pathway. The FDA's constructive feedback and clear guidance suggest a well-defined path toward NDA submission, which is important for the program's advancement. The completion of the Phase 3 trial and positive engagement with regulators indicate strong progress.
Mino-Lok's potential market impact is substantial, addressing the critical issue of CLABSI/CRBSI management. Current standard of care typically requires catheter removal, leading to increased healthcare costs and patient risks. If approved, this catheter lock solution could represent a paradigm shift in treatment approach, potentially creating significant value for both healthcare providers and patients.
However, investors should note that while the meeting was productive, specific details about data requirements or timeline to NDA submission weren't disclosed, suggesting additional work may be needed before filing.
The FDA provided clear, constructive, and actionable guidance during the discussion, underscoring a pathway to support a future New Drug Application (NDA) submission for Mino-Lok. The meeting encompassed an extensive range of topics critical to the NDA process, including in-vitro, clinical efficacy and safety data, and regulatory considerations. Citius Pharma reaffirmed the potential of Mino-Lok to address a critical unmet medical need and its commitment to advancing the program.
"We are highly encouraged by the collaborative and substantive nature of our engagement with the FDA regarding the Mino-Lok program," stated Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. "The FDA's comprehensive feedback supports our commitment to advancing this novel solution for patients who face life-threatening complications from catheter-related infections. The Agency's guidance provides a strong framework for completing the remaining steps toward an NDA submission."
"We believe Mino-Lok has demonstrated compelling clinical outcomes in the Phase 3 trial, supporting its potential to significantly enhance the management of catheter-related bloodstream infections. As a groundbreaking alternative to catheter removal, Mino-Lok, if approved, could reduce healthcare costs, mitigate patient risks, and improve clinical outcomes for individuals requiring central venous catheterization. Citius Pharmaceuticals remains committed to advancing the Mino-Lok® program and will continue to provide updates on regulatory and clinical developments as they unfold," added Mazur.
About Mino-Lok®
Mino-Lok is a novel antibiotic lock solution that combines minocycline, ethanol with edetate disodium designed to treat patients with catheter-related blood stream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an alternative to removing and replacing a central venous catheter (CVC), which may lead to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.
About Citius Pharmaceuticals, Inc.
Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR™, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; Citius Pharma's ability to regain compliance with and continue to meet Nasdaq's continued listing standards; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; risks related to research using our assets but conducted by third parties; our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings which are available on the SEC's website at www.sec.gov, including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on December 29, 2023, as updated by our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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