Cidara Therapeutics Announces Publication of CD388 Preclinical Data in Nature Microbiology
Cidara Therapeutics (CDTX) has published preclinical data for CD388, their influenza drug-Fc conjugate (DFC), in Nature Microbiology. The study demonstrates CD388's potential as a universal preventative treatment for both influenza A and B strains.
The research highlights CD388's key capabilities including:
- Potent activity against all influenza strains, including H5N1 (bird flu)
- Effectiveness against neuraminidase inhibitor-resistant strains
- Low resistance development potential
- Similar efficacy in both immune-competent and immune-compromised models
The company is currently conducting a Phase 2b NAVIGATE trial with approximately 5,000 subjects to evaluate CD388 as a single-dose preventative treatment for seasonal influenza in healthy unvaccinated adults during the 2024-2025 flu season.
Cidara Therapeutics (CDTX) ha pubblicato dati preclinici per CD388, il loro coniugato di farmaco Fc contro l'influenza (DFC), su Nature Microbiology. Lo studio dimostra il potenziale di CD388 come trattamento preventivo universale per i ceppi di influenza A e B.
La ricerca evidenzia le principali capacità di CD388, tra cui:
- Attività potente contro tutti i ceppi di influenza, incluso H5N1 (influenza aviaria)
- Efficacia contro ceppi resistenti agli inibitori della neuraminidasi
- Basso potenziale di sviluppo di resistenza
- Efficacia simile sia in modelli immunocompetenti che immunocompromessi
L'azienda sta attualmente conducendo uno studio di Fase 2b NAVIGATE con circa 5.000 soggetti per valutare CD388 come trattamento preventivo a dose singola per l'influenza stagionale in adulti sani non vaccinati durante la stagione influenzale 2024-2025.
Cidara Therapeutics (CDTX) ha publicado datos preclínicos para CD388, su conjugado de fármaco Fc contra la influenza (DFC), en Nature Microbiology. El estudio demuestra el potencial de CD388 como un tratamiento preventivo universal para las cepas de influenza A y B.
La investigación destaca las capacidades clave de CD388, que incluyen:
- Actividad potente contra todas las cepas de influenza, incluyendo H5N1 (gripe aviar)
- Eficacia contra cepas resistentes a los inhibidores de la neuraminidasa
- Bajo potencial de desarrollo de resistencia
- Eficacia similar en modelos inmunocompetentes e inmunocomprometidos
La empresa está llevando a cabo actualmente un ensayo de Fase 2b NAVIGATE con aproximadamente 5,000 sujetos para evaluar CD388 como tratamiento preventivo de dosis única para la influenza estacional en adultos sanos no vacunados durante la temporada de gripe 2024-2025.
시다라 테라퓨틱스 (CDTX)는 그들의 인플루엔자 약물-Fc 접합체 (DFC)인 CD388에 대한 전임상 데이터를 Nature Microbiology에 발표했습니다. 이 연구는 CD388이 인플루엔자 A와 B 균주에 대한 보편적인 예방 치료제로서의 잠재력을 보여줍니다.
연구는 CD388의 주요 능력을 강조합니다:
- 모든 인플루엔자 균주에 대한 강력한 활성을 포함하여 H5N1 (조류 인플루엔자)에 대한 효과
- 뉴라민산 분해효소 억제제에 저항성인 균주에 대한 효과
- 저항성 개발 가능성이 낮음
- 면역이 있는 모델과 면역이 손상된 모델 모두에서 유사한 효능
회사는 현재 약 5,000명의 피험자를 대상으로 2024-2025 독감 시즌 동안 건강한 미접종 성인을 위한 단일 용량 예방 치료제로 CD388을 평가하기 위한 2b 단계 NAVIGATE 시험을 진행 중입니다.
Cidara Therapeutics (CDTX) a publié des données précliniques pour CD388, leur conjugué de médicament Fc contre la grippe (DFC), dans Nature Microbiology. L'étude démontre le potentiel de CD388 en tant que traitement préventif universel pour les souches de grippe A et B.
La recherche met en avant les principales capacités de CD388, notamment :
- Activité puissante contre toutes les souches de grippe, y compris H5N1 (grippe aviaire)
- Efficacité contre les souches résistantes aux inhibiteurs de la neuraminidase
- Faible potentiel de développement de résistance
- Efficacité similaire dans les modèles immunocompétents et immunodéprimés
L'entreprise mène actuellement un essai de Phase 2b NAVIGATE avec environ 5 000 sujets pour évaluer CD388 comme traitement préventif à dose unique pour la grippe saisonnière chez des adultes sains non vaccinés pendant la saison de grippe 2024-2025.
Cidara Therapeutics (CDTX) hat präklinische Daten zu CD388, ihrem Influenza-Arzneimittel-Fc-Konjugat (DFC), in Nature Microbiology veröffentlicht. Die Studie zeigt das Potenzial von CD388 als universelle präventive Behandlung für die Influenza-A- und B-Stämme.
Die Forschung hebt die wichtigsten Fähigkeiten von CD388 hervor, darunter:
- Starke Aktivität gegen alle Influenza-Stämme, einschließlich H5N1 (Vogelgrippe)
- Wirksamkeit gegen neuraminidase-resistente Stämme
- Geringes Potenzial für die Entwicklung von Resistenzen
- Ähnliche Wirksamkeit in sowohl immuncompetenten als auch immun-kompromittierten Modellen
Das Unternehmen führt derzeit eine Phase-2b NAVIGATE-Studie mit etwa 5.000 Probanden durch, um CD388 als einmalige präventive Behandlung für saisonale Influenza bei gesunden, nicht geimpften Erwachsenen während der Influenza-Saison 2024-2025 zu bewerten.
- Successful preclinical results published in prestigious Nature Microbiology journal
- CD388 demonstrates universal effectiveness against all influenza strains including resistant variants
- Large-scale Phase 2b trial with 5,000 subjects currently ongoing
- Product shows potential for both regular and immunocompromised populations
- Still in clinical development phase with no guaranteed market approval
- Efficacy in human trials yet to be proven
Insights
The publication of CD388 preclinical data in Nature Microbiology represents significant scientific validation for Cidara's Cloudbreak platform. This is particularly noteworthy as publication in such a prestigious journal indicates rigorous peer review of their drug-Fc conjugate approach.
The preclinical data reveals three critical advantages: universal activity against influenza strains (including highly pathogenic H5N1), low resistance potential, and efficacy regardless of immune status. This last point addresses a critical unmet need, as current influenza vaccines provide suboptimal protection for immunocompromised patients.
Mechanistically, CD388 targets viral neuraminidase while leveraging the Fc domain for extended half-life - combining small molecule potency with antibody-like durability. This fundamental design appears to drive efficacy through direct antiviral activity rather than immune stimulation, explaining its effectiveness in immunocompromised models.
The advancement to a ~5,000 subject Phase 2b trial demonstrates confidence in the approach, though investors should recognize that preclinical success doesn't guarantee clinical outcomes. The timing during a "particularly severe" flu season offers ideal conditions for demonstrating efficacy, potentially enhancing the signal detection compared to milder seasons.
This Nature Microbiology publication enhances Cidara's scientific credibility at a important time as the company approaches data readout from its Phase 2b NAVIGATE trial. The study's large size (~5,000 subjects) and the "particularly severe" 2024-2025 flu season create favorable conditions for demonstrating clinical benefit.
The influenza prevention market represents a substantial opportunity. Current vaccines show variable effectiveness (typically
Beyond CD388 specifically, this publication validates Cidara's proprietary Cloudbreak platform, potentially increasing partnership interest across their pipeline. The drug-Fc conjugate approach represents a differentiated technology that could be applied to multiple infectious disease targets.
While this scientific validation is meaningful, investors should focus primarily on the upcoming Phase 2b results as the decisive near-term catalyst. Success would likely trigger significant value creation, while failure would raise questions about the platform's clinical translatability. The publication reduces scientific risk somewhat but does not eliminate the substantial clinical development risks ahead.
Data highlights potential of CD388 as a potent, universal antiviral for influenza prevention regardless of immune status
SAN DIEGO, March 17, 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 the publication of preclinical data assessing CD388, the company’s influenza DFC, in the peer-reviewed scientific journal Nature Microbiology. The article, entitled “Drug-Fc Conjugate CD388 targets influenza virus neuraminidase and is broadly protective in mice,” highlights the potential of CD388 as a potent, universal preventative for influenza A and B in healthy and high-risk populations.
“This publication, combined with the promising clinical data we’ve generated to date, further validates our Cloudbreak DFC platform and the potential of CD388 to offer universal protection against both seasonal and pandemic influenza strains,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “While vaccines play a vital role in flu prevention, they do not offer sufficient protection, particularly for immune-compromised individuals, underscoring the critical need for a durable, broadly acting antiviral like CD388. We look forward to the results of our ~5,000 subject Phase 2b NAVIGATE study that is evaluating CD388 during the particularly severe 2024-2025 flu season.”
Les Tari, Ph.D., chief scientific officer of Cidara added, “DFCs are a unique drug modality with the potential to enhance the efficacy and safety of targeted small molecules, while combining them with the long half-lives of monoclonal antibodies. These preclinical data indicate that CD388’s efficacy is driven by the intrinsic antiviral activity of the drug, potentially enabling it to work as a long-term preventative against influenza regardless of immune status.”
Key Findings
- The publication describes CD388 and its potential for universal activity across influenza A and B viruses in cellular and animal models.
- Administration of CD388 resulted in the following:
- Potent, universal activity against all influenza A and B virus strains, including high pathogenicity strains like H5N1, also known as avian influenza or bird flu, and strains that are resistant to approved neuraminidase inhibitors
- Low potential for resistance development
- Efficacy at similar exposures in immune-competent and immune-compromised lethal challenge models in mice demonstrating that efficacy is driven predominantly by the intrinsic antiviral activity of CD388
- Administration of CD388 resulted in the following:
CD388 is currently under clinical evaluation in the ~5000 patient Phase 2b NAVIGATE trial, evaluating CD388 for the single-dose prevention of seasonal influenza in healthy unvaccinated adult subjects.
About CD388
CD388 is an investigational drug-Fc conjugate (DFC) comprising 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 Phase 2b enrollment 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 and when we will complete our Phase 2b NAVIGATE trial, and whether animal data will be predictive of safety or effectiveness of CD388 in prevention of influenza infection in humans. 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, the impacts of the realignment and restructuring being different than expected 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 most recent Quarterly Report on Form 10-Q 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
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LifeSci Communications
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FAQ
What are the main findings of CD388's preclinical study published in Nature Microbiology?
How many participants are involved in CDTX's Phase 2b NAVIGATE trial for CD388?
What advantage does CD388 offer over traditional flu vaccines according to CDTX?
What is the current development stage of Cidara's CD388 influenza treatment?
