Cidara Therapeutics Announces Two Presentations on CD388 in Influenza at International Conference on Antiviral Research (ICAR) 2025
Cidara Therapeutics (CDTX) announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR) focusing on their drug candidate CD388 for influenza prevention.
The first presentation covers the Phase 2b NAVIGATE trial, which has completed enrollment of over 5,000 participants in the US and UK. The trial evaluates CD388's safety and preventative efficacy, administered via subcutaneous injection. Previous Phase 1 and 2a data showed the drug was well-tolerated and efficacious in healthy volunteers.
The second presentation addresses modeling of seasonal influenza variations to support clinical dose selection. The research demonstrates that while standard proportion tests are sensitive to seasonal flu variations, their model-based analysis improves decision power for CD388's Phase 3 dose selection.
Cidara Therapeutics (CDTX) ha annunciato due prossime presentazioni alla 38ª Conferenza Internazionale sulla Ricerca Antivirale (ICAR) che si concentrano sul loro candidato farmaco CD388 per la prevenzione dell'influenza.
La prima presentazione riguarda lo studio di Fase 2b NAVIGATE, che ha completato l'arruolamento di oltre 5.000 partecipanti negli Stati Uniti e nel Regno Unito. Lo studio valuta la sicurezza e l'efficacia preventiva di CD388, somministrato tramite iniezione sottocutanea. I dati precedenti delle fasi 1 e 2a hanno dimostrato che il farmaco è stato ben tollerato ed efficace in volontari sani.
La seconda presentazione affronta la modellazione delle variazioni dell'influenza stagionale per supportare la selezione della dose clinica. La ricerca dimostra che, mentre i test di proporzione standard sono sensibili alle variazioni dell'influenza stagionale, la loro analisi basata su modelli migliora il potere decisionale per la selezione della dose di Fase 3 di CD388.
Cidara Therapeutics (CDTX) anunció dos próximas presentaciones en la 38ª Conferencia Internacional sobre Investigación Antiviral (ICAR) centradas en su candidato a fármaco CD388 para la prevención de la influenza.
La primera presentación cubre el ensayo de Fase 2b NAVIGATE, que ha completado la inscripción de más de 5,000 participantes en EE. UU. y el Reino Unido. El ensayo evalúa la seguridad y la eficacia preventiva de CD388, administrado mediante inyección subcutánea. Los datos anteriores de las fases 1 y 2a mostraron que el fármaco fue bien tolerado y eficaz en voluntarios sanos.
La segunda presentación aborda la modelización de las variaciones de la influenza estacional para apoyar la selección de dosis clínicas. La investigación demuestra que, aunque las pruebas de proporción estándar son sensibles a las variaciones de la gripe estacional, su análisis basado en modelos mejora el poder de decisión para la selección de la dosis de Fase 3 de CD388.
시다라 테라퓨틱스 (CDTX)는 독감 예방을 위한 약물 후보 CD388에 초점을 맞춘 제38회 국제 항바이러스 연구 회의 (ICAR)에서 두 가지 발표를 예정하고 있다고 발표했습니다.
첫 번째 발표는 미국과 영국에서 5,000명 이상의 참가자를 모집 완료한 2b 단계 NAVIGATE 시험을 다룹니다. 이 시험은 피하 주사를 통해 투여되는 CD388의 안전성과 예방 효능을 평가합니다. 이전의 1단계 및 2a 단계 데이터는 이 약물이 건강한 자원자에게 잘 견뎌지고 효과적임을 보여주었습니다.
두 번째 발표는 임상 용량 선택을 지원하기 위한 계절성 독감 변동 모델링을 다룹니다. 연구 결과, 표준 비율 테스트는 계절 독감 변동에 민감하지만, 모델 기반 분석은 CD388의 3단계 용량 선택에 대한 결정력을 향상시킵니다.
Cidara Therapeutics (CDTX) a annoncé deux présentations à venir lors de la 38e Conférence Internationale sur la Recherche Antivirale (ICAR) axées sur leur candidat médicament CD388 pour la prévention de la grippe.
La première présentation couvre l'essai de Phase 2b NAVIGATE, qui a complété le recrutement de plus de 5 000 participants aux États-Unis et au Royaume-Uni. L'essai évalue la sécurité et l'efficacité préventive de CD388, administré par injection sous-cutanée. Les données des phases 1 et 2a précédentes ont montré que le médicament était bien toléré et efficace chez des volontaires en bonne santé.
La deuxième présentation aborde la modélisation des variations saisonnières de la grippe pour soutenir la sélection de la dose clinique. La recherche démontre que, bien que les tests de proportion standard soient sensibles aux variations saisonnières de la grippe, leur analyse basée sur des modèles améliore le pouvoir décisionnel pour la sélection de la dose de Phase 3 de CD388.
Cidara Therapeutics (CDTX) hat zwei bevorstehende Präsentationen auf der 38. Internationalen Konferenz zur Antiviralen Forschung (ICAR) angekündigt, die sich auf ihren Arzneimittelkandidaten CD388 zur Influenza-Prävention konzentrieren.
Die erste Präsentation behandelt die Phase-2b-Studie NAVIGATE, die die Rekrutierung von über 5.000 Teilnehmern in den USA und Großbritannien abgeschlossen hat. Die Studie bewertet die Sicherheit und die präventive Wirksamkeit von CD388, das subkutan injiziert wird. Frühere Daten der Phase 1 und 2a zeigten, dass das Medikament gut verträglich und wirksam bei gesunden Freiwilligen war.
Die zweite Präsentation befasst sich mit der Modellierung saisonaler Influenza-Variationen zur Unterstützung der klinischen Dosiswahl. Die Forschung zeigt, dass, während Standardproportionsprüfungen empfindlich auf saisonale Grippevariationen reagieren, ihre modellbasierte Analyse die Entscheidungskraft für die Dosiswahl der Phase 3 von CD388 verbessert.
- Completed enrollment of large-scale Phase 2b trial with over 5,000 participants
- Positive Phase 1 and 2a clinical data showing good tolerability and efficacy
- Advanced modeling analysis improves clinical dose selection process
- None.
SAN DIEGO, March 18, 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 two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR). The conference takes place from March 17-21, 2025 in Las Vegas, Nevada. Cidara’s presentations will highlight the study design, demographic information, and preliminary safety data from the ongoing Phase 2b NAVIGATE trial of CD388, as well as dose optimization models for evaluation of CD388 in a Phase 3 study.
Presentation details:
Title: NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Study to Evaluate the Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for Prevention of Influenza in Subjects not at Risk for Influenza Complications
Presenter: James Alexander
Abstract number: 361
Date/Time: Poster Session 1: Tuesday, March 18, 2025, 5:15-6:15pm PT; Poster Session 2: Thursday, March 20, 2025, 9-10am PT
Summary: The Phase 2b NAVIGATE trial to evaluate the safety and preventative efficacy of CD388 in a real-world environment completed enrollment of more than 5,000 participants in the United States and the UK. Prior Phase 1 and Phase 2a clinical data have shown that CD388, administered by subcutaneous injection, appeared to be well-tolerated and efficacious in healthy human volunteer studies. The results of the Phase 2b trial will inform dose selection and design for the planned Phase 3 development program.
Title: Real World Data-Based Modeling of Seasonal Influenza Variations to Support Clinical Dose Selection of CD388, A Novel Antiviral in Development for Prevention of Seasonal and Pandemic Influenza
Presenter: Shawn Flanagan
Abstract number: 352
Date/Time: Poster Session 1: Tuesday, March 18, 2025, 6:15-7:15pm PT; Poster Session 2: Thursday, March 20, 2025, 8-9am PT
Summary: In trials involving community acquired infections, like influenza, variations in disease incidence over time may complicate interpretation of drug effect in Phase 2 and Phase 3 trials across multiple seasons, especially for long-acting drugs like CD388. Advanced model-based analysis was conducted to improve decision power based on simulated Phase 2 results over different flu seasons. While a standard proportions test was shown to be sensitive to influenza seasonal variations, the model-based analysis was not and increased decision power for clinical dose selection of CD388 for Phase 3.
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, 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
What are the key findings from CD388's Phase 2b NAVIGATE trial by Cidara (CDTX)?
How is Cidara (CDTX) addressing seasonal variation challenges in CD388's clinical trials?
What is the current development stage of Cidara's (CDTX) CD388 influenza prevention drug?
What population is being studied in CDTX's NAVIGATE trial for CD388?
