Cidara Therapeutics to Participate in World Health Organization Meeting on H5N1 Influenza Preparedness and Response
Cidara Therapeutics (CDTX) announced its participation in a important World Health Organization (WHO) panel discussion on H5N1 influenza preparedness and response, scheduled for March 19, 2025. The virtual meeting, focusing on research preparation and response to H5N1 influenza outbreaks, will feature Cidara in the 'Other pharmaceuticals as preventive tools' panel.
The company's chief scientific officer, Les Tari, Ph.D., will discuss CD388, their long-acting antiviral influenza preventative currently undergoing a 5,000-subject Phase 2b study. The drug has shown promising results against all influenza A and B strains, including H5N1, in preclinical studies.
The WHO meeting aims to address H5N1, a highly infectious avian influenza virus affecting birds and mammals, including humans. Key objectives include identifying knowledge gaps, outlining regulatory pathways for mRNA vaccines, and reviewing therapeutics such as monoclonal antibodies and long-acting antivirals.
Cidara Therapeutics (CDTX) ha annunciato la sua partecipazione a un'importante discussione del panel dell'Organizzazione Mondiale della Sanità (OMS) sulla preparazione e risposta all'influenza H5N1, programmata per il 19 marzo 2025. L'incontro virtuale, incentrato sulla preparazione alla ricerca e sulla risposta agli focolai di influenza H5N1, vedrà Cidara nel panel 'Altri farmaci come strumenti preventivi'.
Il direttore scientifico dell'azienda, Les Tari, Ph.D., discuterà di CD388, il loro antivirale a lunga durata per la prevenzione dell'influenza attualmente in fase di studio di Fase 2b su 5.000 soggetti. Il farmaco ha mostrato risultati promettenti contro tutti i ceppi di influenza A e B, incluso l'H5N1, negli studi preclinici.
L'incontro dell'OMS mira ad affrontare H5N1, un virus altamente infettivo dell'influenza aviaria che colpisce uccelli e mammiferi, compresi gli esseri umani. Gli obiettivi chiave includono l'identificazione delle lacune di conoscenza, la definizione dei percorsi normativi per i vaccini mRNA e la revisione dei terapeutici come anticorpi monoclonali e antivirali a lunga durata.
Cidara Therapeutics (CDTX) anunció su participación en una importante discusión del panel de la Organización Mundial de la Salud (OMS) sobre la preparación y respuesta a la influenza H5N1, programada para el 19 de marzo de 2025. La reunión virtual, centrada en la preparación de la investigación y la respuesta a brotes de influenza H5N1, contará con Cidara en el panel 'Otros fármacos como herramientas preventivas'.
El director científico de la empresa, Les Tari, Ph.D., discutirá CD388, su antiviral de acción prolongada para la prevención de la influenza que actualmente está en un estudio de Fase 2b con 5,000 sujetos. El medicamento ha mostrado resultados prometedores contra todas las cepas de influenza A y B, incluida H5N1, en estudios preclínicos.
La reunión de la OMS tiene como objetivo abordar H5N1, un virus de influenza aviar altamente infeccioso que afecta a aves y mamíferos, incluidos los humanos. Los objetivos clave incluyen identificar brechas de conocimiento, delinear vías regulatorias para las vacunas de ARNm y revisar terapias como anticuerpos monoclonales y antivirales de acción prolongada.
시다라 테라퓨틱스 (CDTX)는 2025년 3월 19일 예정된 H5N1 인플루엔자 대비 및 대응에 관한 세계 보건 기구 (WHO) 패널 토론에 참여한다고 발표했습니다. H5N1 인플루엔자 발생에 대한 연구 준비 및 대응에 중점을 둔 이 가상 회의에서 시다라는 '예방 도구로서의 기타 의약품' 패널에 참여할 예정입니다.
회사의 최고 과학 책임자 Les Tari 박사는 현재 5,000명의 피험자를 대상으로 진행 중인 2b상 시험 중인 장기 작용 항바이러스 인플루엔자 예방제인 CD388에 대해 논의할 것입니다. 이 약물은 전임상 연구에서 H5N1을 포함한 모든 인플루엔자 A 및 B 균주에 대해 유망한 결과를 보였습니다.
WHO 회의는 조류와 포유류, 인간을 포함한 H5N1이라는 매우 전염성이 강한 조류 인플루엔자 바이러스에 대해 다루는 것을 목표로 합니다. 주요 목표는 지식의 격차를 식별하고, mRNA 백신에 대한 규제 경로를 개략적으로 설명하며, 단클론 항체 및 장기 작용 항바이러스제와 같은 치료법을 검토하는 것입니다.
Cidara Therapeutics (CDTX) a annoncé sa participation à une importante discussion de panel de l'Organisation mondiale de la santé (OMS) sur la préparation et la réponse à l'influenza H5N1, prévue pour le 19 mars 2025. La réunion virtuelle, axée sur la préparation de la recherche et la réponse aux épidémies d'influenza H5N1, mettra en avant Cidara dans le panel 'Autres médicaments comme outils préventifs'.
Le directeur scientifique de l'entreprise, Les Tari, Ph.D., discutera de CD388, leur antiviral à action prolongée pour la prévention de l'influenza, actuellement en cours d'étude de Phase 2b sur 5 000 sujets. Le médicament a montré des résultats prometteurs contre toutes les souches d'influenza A et B, y compris H5N1, dans des études précliniques.
La réunion de l'OMS vise à aborder H5N1, un virus de la grippe aviaire hautement infectieux affectant les oiseaux et les mammifères, y compris les humains. Les objectifs clés incluent l'identification des lacunes de connaissances, la définition des voies réglementaires pour les vaccins à ARNm et l'examen des thérapies telles que les anticorps monoclonaux et les antiviraux à action prolongée.
Cidara Therapeutics (CDTX) gab bekannt, dass sie an einer wichtigen Podiumsdiskussion der Weltgesundheitsorganisation (WHO) zur Vorbereitung und Reaktion auf H5N1-Influenza teilnehmen wird, die für den 19. März 2025 geplant ist. Das virtuelle Treffen, das sich auf die Forschungsvorbereitung und die Reaktion auf H5N1-Influenza-Ausbrüche konzentriert, wird Cidara im Panel 'Andere Arzneimittel als präventive Werkzeuge' präsentieren.
Der wissenschaftliche Leiter des Unternehmens, Les Tari, Ph.D., wird über CD388 sprechen, ihr langwirksames antivirales Mittel zur Prävention von Influenza, das sich derzeit in einer Phase-2b-Studie mit 5.000 Probanden befindet. Das Medikament hat in präklinischen Studien vielversprechende Ergebnisse gegen alle Influenza-A- und B-Stämme, einschließlich H5N1, gezeigt.
Das Ziel des WHO-Meetings ist es, H5N1, ein hochinfektiöses Vogelgrippevirus, das Vögel und Säugetiere, einschließlich Menschen, betrifft, zu behandeln. Zu den wichtigsten Zielen gehören die Identifizierung von Wissenslücken, die skizzierung von regulatorischen Wegen für mRNA-Impfstoffe und die Überprüfung von Therapeutika wie monoklonalen Antikörpern und langwirksamen Antiviralen.
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SAN DIEGO, March 19, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies, today announced participation in the “Other pharmaceuticals as preventive tools” panel at a World Health Organization (WHO) global meeting on H5N1 influenza preparedness and response. The meeting, titled “What research is important to prepare and respond to H5N1 influenza outbreaks,” will be held virtually on March 19, 2025, from 1:00-7:15pm Central European Time (CET)/5:00-11:15am Pacific Time (PT), and the panel discussion will take place from 6:30-7:00 pm CET/10:30-11:00am PT.
“Global discussion forums are critical for the development of effective treatments to combat outbreaks of influenza, including the growing threat of H5N1,” said Les Tari, Ph.D., chief scientific officer of Cidara. “As the virus spreads, the need for robust strategies to prevent and respond to flu outbreaks is becoming increasingly critical. Our long-acting antiviral influenza preventative, CD388, currently in a 5,000 subject Phase 2b study, shows promise as a new modality that has demonstrated potent activity against all influenza A and B strains, including H5N1, in preclinical studies. I look forward to discussing the potential of CD388 with global leaders as a universal preventative of influenza outbreaks.”
H5N1 is one of several influenza viruses that causes a highly infectious respiratory disease in birds called avian influenza (or "bird flu"). Infections in mammals, including humans, have also been documented.
Meeting details:
Influenza H5 pathogens have been included in the list of priority pathogens by the WHO R&D Blueprint for Epidemics. To coordinate efforts for research preparedness of H5N1 outbreaks, this global consultation will review current and novel vaccines and preventive pharmaceuticals. The key objectives of this meeting are to identify knowledge gaps and priority research questions, outline regulatory pathways for mRNA vaccines and other novel approaches, and review other therapeutics, including monoclonal antibodies and long-acting antivirals.
About CD388
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/.
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company announced completion of enrollment of its Phase 2b NAVIGATE trial in December 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “intends,” “believes,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the potential of and future plans for CD388, whether CD388 will have activity against H5N1 and other potential pandemic influenza strains, and promising CD388 clinical data generated to date. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles on the enrollment of patients or other aspects of CD388 or other DFC development and other risks and uncertainties associated with Cidara’s business in general. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and other filings subsequently made with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
(628) 234-3889
mfitzhugh@lifescicomms.com
FAQ
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