Cidara Therapeutics Completes Enrollment of Phase 2b NAVIGATE Trial Evaluating CD388 for Prevention of Seasonal Influenza
Cidara Therapeutics (CDTX) has completed enrollment of 5,000 subjects in its Phase 2b NAVIGATE trial, evaluating CD388 for pre-exposure prophylaxis of seasonal influenza. The study, conducted across US and UK clinical sites, is designed to assess the efficacy and safety of CD388 as a long-acting, universal influenza preventative.
The randomized, double-blind, controlled trial involves healthy, unvaccinated adult subjects not at risk of influenza complications. Participants receive single doses of CD388 (150mg, 300mg, or 450mg) or placebo at the start of flu season and are monitored for breakthrough cases throughout the season. The trial will evaluate safety, pharmacokinetics, and rates of laboratory and clinically confirmed influenza.
Cidara Therapeutics (CDTX) ha completato l'arruolamento di 5.000 soggetti nel suo trial di Fase 2b NAVIGATE, che valuta il CD388 per la profilassi pre-esposizione dell'influenza stagionale. Lo studio, condotto in siti clinici negli Stati Uniti e nel Regno Unito, è progettato per valutare l'efficacia e la sicurezza del CD388 come preventiva universale a lungo termine contro l'influenza.
Il trial randomizzato, in doppio cieco e controllato, coinvolge soggetti adulti sani e non vaccinati che non sono a rischio di complicazioni influenzali. I partecipanti ricevono dosi singole di CD388 (150mg, 300mg o 450mg) o placebo all'inizio della stagione influenzale e sono monitorati per casi di influenza durante tutta la stagione. Il trial valuterà la sicurezza, la farmacocinetica e i tassi di influenza confermata in laboratorio e clinicamente.
Cidara Therapeutics (CDTX) ha completado la inscripción de 5,000 sujetos en su ensayo de Fase 2b NAVIGATE, que evalúa el CD388 para la profilaxis previa a la exposición a la influenza estacional. El estudio, llevado a cabo en sitios clínicos de EE. UU. y el Reino Unido, está diseñado para evaluar la eficacia y seguridad del CD388 como un preventivo universal de larga duración contra la influenza.
El ensayo es aleatorizado, doble ciego y controlado, e involucra sujetos adultos sanos no vacunados que no están en riesgo de complicaciones por influenza. Los participantes reciben dosis únicas de CD388 (150mg, 300mg o 450mg) o placebo al inicio de la temporada de influenza y se les monitoriza por casos de influenza durante toda la temporada. El ensayo evaluará la seguridad, la farmacocinética y las tasas de influenza confirmada en laboratorio y clínicamente.
시다라 치료제 (CDTX)는 계절성 인플루엔자에 대한 노출 전 예방을 위해 CD388을 평가하는 2b기 NAVIGATE 시험에 5,000명의 피험자 등록을 완료했습니다. 미국과 영국의 임상 사이트에서 실시되는 이 연구는 CD388의 장기적인 범용 인플루엔자 예방효과와 안전성을 평가하기 위해 설계되었습니다.
이 무작위, 이중 맹검, 대조군 시험은 인플루엔자 합병증 위험이 없는 건강한 비백신 성인 피험자를 포함합니다. 참가자는 인플루엔자 시즌 시작 시 CD388(150mg, 300mg 또는 450mg) 또는 위약의 단일 용량을 받으며, 시즌 전체에 걸쳐 돌발 사례를 모니터링합니다. 이 시험은 안전성, 약물 동태학 및 실험실에서 확인된 인플루엔자와 임상적으로 확인된 인플루엔자 비율을 평가할 것입니다.
Cidara Therapeutics (CDTX) a achevé le recrutement de 5 000 sujets dans son essai de Phase 2b NAVIGATE, évaluant le CD388 pour la prophylaxie pré-exposition de la grippe saisonnière. L'étude, réalisée sur des sites cliniques aux États-Unis et au Royaume-Uni, est conçue pour évaluer l'efficacité et la sécurité du CD388 en tant que préventif universel à action prolongée contre la grippe.
L'essai randomisé, en double aveugle et contrôlé, implique des adultes en bonne santé, non vaccinés et non à risque de complications grippales. Les participants reçoivent des doses uniques de CD388 (150mg, 300mg ou 450mg) ou un placebo au début de la saison de la grippe et sont surveillés pour des cas d'influenza tout au long de la saison. L'essai évaluera la sécurité, la pharmacocinétique et les taux de grippe confirmés en laboratoire et cliniquement.
Cidara Therapeutics (CDTX) hat die Einschreibung von 5.000 Probanden in seine Phase-2b-Studie NAVIGATE abgeschlossen, die CD388 zur Präexpositionsprophylaxe gegen saisonale Influenza bewertet. Die Studie, die an klinischen Standorten in den USA und im Vereinigten Königreich durchgeführt wird, ist darauf ausgelegt, die Wirksamkeit und Sicherheit von CD388 als langfristige universelle Influenza-Prävention zu beurteilen.
Die randomisierte, doppelblinde, kontrollierte Studie umfasst gesunde, nicht geimpfte erwachsene Probanden, die kein Risiko für Influenza-Komplikationen haben. Die Teilnehmer erhalten zu Beginn der Influenza-Saison Einzelgaben von CD388 (150mg, 300mg oder 450mg) oder ein Placebo und werden während der gesamten Saison auf Durchbruchsfälle überwacht. Die Studie wird die Sicherheit, Pharmakokinetik und die Raten von im Labor und klinisch bestätigter Influenza bewerten.
- Successful completion of planned enrollment target of 5,000 subjects
- Strategic timing of trial completion coinciding with northern hemisphere flu season
- Trial advancement positions company to evaluate potential long-acting universal flu prevention
- None.
Insights
The completion of enrollment for the Phase 2b NAVIGATE trial represents a significant milestone in CD388's development pathway. With 5,000 subjects enrolled across US and UK sites, this large-scale trial provides robust statistical power to evaluate efficacy. The timing aligns strategically with the northern hemisphere flu season, optimizing the potential to gather meaningful efficacy data.
The trial design is particularly noteworthy, testing three different dosing levels (
The study's emphasis on both laboratory and clinical confirmation of influenza cases strengthens the trial's validity. If successful, CD388 could potentially revolutionize flu prevention by offering long-acting protection through a single dose.
This development holds substantial market potential for Cidara Therapeutics. The global influenza vaccine market is projected to reach
Cidara's stock could see increased attention as results from this trial emerge, given the substantial market opportunity and innovative approach. The successful completion of enrollment reduces operational risk and provides clearer visibility on potential timeline to results. With a market cap of
SAN DIEGO, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced it has reached full planned enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial across clinical sites in the US and UK. The trial is designed to evaluate the efficacy and safety of CD388, the company’s DFC for the pre-exposure prophylaxis of seasonal influenza.
“Completing the NAVIGATE study at the beginning of the northern hemisphere flu season was a critical milestone to evaluate the efficacy and safety of CD388 as a potential long-acting, universal influenza preventative,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Thanks to the efforts of our investigators and clinical teams, we are now well-positioned to advance the study as this year’s flu season unfolds.”
The Phase 2b NAVIGATE clinical trial is a randomized, double-blind, controlled trial in healthy, unvaccinated adult subjects who are not at risk of complications from influenza. The objective of the study is to evaluate safety, pharmacokinetics and the rates of laboratory and clinically confirmed influenza in subjects receiving the single doses of CD388 (150mg, 300mg, 450mg) or placebo administered once at the beginning of the flu season. Subjects are then followed for the remainder of the influenza season to monitor for breakthrough cases.
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 initiation of a Phase 2b trial in September 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, our Phase 2b NAVIGATE trial study design and locations for sites and the impact of new SAB members. 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.
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