Cidara Therapeutics Announces First Subjects Dosed in Phase 2b NAVIGATE Trial Evaluating CD388 for the Prevention of Seasonal Influenza
Cidara Therapeutics (Nasdaq: CDTX) has announced the initiation of its Phase 2b NAVIGATE trial, evaluating CD388 for the prevention of seasonal influenza. The study has begun dosing the first subjects and aims to enroll 5,000 healthy unvaccinated adults across clinical sites in the US and UK.
The trial is designed as a randomized, double-blind, controlled study with three CD388 dose groups and a placebo group. Subjects will receive a single dose at the start of the flu season and be monitored for breakthrough cases. The study will compare rates of laboratory and clinically confirmed influenza between the CD388 and placebo groups.
CD388, developed using Cidara's proprietary Cloudbreak® platform, is a drug-Fc conjugate (DFC) immunotherapy. Unlike vaccines, it does not rely on an immune response, potentially offering protection regardless of immune status. The therapy has shown promise in preventing infection by both seasonal and pandemic strains of influenza A and B.
Cidara Therapeutics (Nasdaq: CDTX) ha annunciato l'inizio del suo studio di Fase 2b denominato NAVIGATE, che valuta CD388 per la prevenzione dell'influenza stagionale. Lo studio ha iniziato a somministrare il trattamento ai primi soggetti e mira a reclutare 5.000 adulti sani non vaccinati in vari centri clinici negli Stati Uniti e nel Regno Unito.
Il trial è progettato come uno studio randomizzato, in doppio cieco e controllato con tre gruppi di dosaggio di CD388 e un gruppo placebo. I soggetti riceveranno una singola dose all'inizio della stagione influenzale e saranno monitorati per eventuali casi di infezione. Lo studio confronterà i tassi di influenza confermata in laboratorio e clinicamente tra i gruppi CD388 e placebo.
CD388, sviluppato utilizzando la piattaforma proprietaria Cloudbreak® di Cidara, è un immunoterapia congiugata farmaco-Fc (DFC). A differenza dei vaccini, non si basa su una risposta immunitaria, offrendo potenzialmente protezione indipendentemente dallo stato immunitario. La terapia ha dimostrato di avere efficacia nella prevenzione delle infezioni sia da ceppi stagionali che pandemici di influenza A e B.
Cidara Therapeutics (Nasdaq: CDTX) ha anunciado el inicio de su ensayo clínico de Fase 2b, denominado NAVIGATE, que evalúa CD388 para la prevención de la influenza estacional. El estudio ha comenzado a administrar el tratamiento a los primeros sujetos y tiene como objetivo reclutar a 5.000 adultos sanos no vacunados en sitios clínicos en EE. UU. y Reino Unido.
El ensayo está diseñado como un estudio aleatorizado, doble ciego y controlado con tres grupos de dosis de CD388 y un grupo placebo. Los sujetos recibirán una dosis única al inicio de la temporada de gripe y serán monitorizados por casos de infección. El estudio comparará las tasas de influenza confirmada en laboratorio y clínicamente entre los grupos de CD388 y placebo.
CD388, desarrollado utilizando la plataforma Cloudbreak® propietaria de Cidara, es una inmunoterapia conjugada de fármaco-Fc (DFC). A diferencia de las vacunas, no depende de una respuesta inmunitaria, ofreciendo potencialmente protección independientemente del estado inmune. La terapia ha mostrado promesas en la prevención de infecciones por cepas estacionales y pandémicas de influenza A y B.
시다라 테라퓨틱스(Cidara Therapeutics, Nasdaq: CDTX)는 CD388을 평가하는 2b상 NAVIGATE 임상 시험의 시작을 발표했습니다. 이번 연구는 계절 독감 예방을 목표로 하며, 첫 번째 피험자들에게 약물 투여를 시작하였고 미국과 영국의 임상 사이트에서 5,000명의 건강한 미접종 성인을 모집할 계획입니다.
이 시험은 세 개의 CD388 용량 그룹과 한 개의 플라시보 그룹을 포함하는 무작위 이중 맹검 통제 연구로 설계되었습니다. 피험자들은 독감 시즌 시작 시 단 한 번의 투여를 받고, 돌발 사례를 모니터링합니다. 연구는 CD388 그룹과 플라시보 그룹 간의 실험실 및 임상적으로 확인된 독감 발생률을 비교합니다.
CD388은 시다라의 독점 Cloudbreak® 플랫폼을 사용하여 개발된 약물-Fc 접합 면역요법(DFC)입니다. 백신과는 달리 면역 반응에 의존하지 않으며, 면역 상태와 관계없이 보호를 제공할 수 있습니다. 이 요법은 계절성 및 팬데믹 A, B 독감 감염 예방에 유망한 성과를 보였습니다.
Cidara Therapeutics (Nasdaq: CDTX) a annoncé le lancement de son essai de Phase 2b intitulé NAVIGATE, évaluant CD388 pour la prévention de la grippe saisonnière. L'étude a commencé à traiter les premiers sujets et vise à recruter 5 000 adultes en bonne santé non vaccinés dans des centres cliniques aux États-Unis et au Royaume-Uni.
L'essai est conçu comme une étude randomisée, en double aveugle et contrôlée avec trois groupes de dosage CD388 et un groupe placebo. Les sujets recevront une dose unique au début de la saison grippale et seront surveillés pour des cas d'infection. L'étude comparera les taux de grippe confirmés au laboratoire et cliniquement entre les groupes CD388 et placebo.
CD388, développé à l'aide de la plateforme Cloudbreak® propriétaire de Cidara, est une immunothérapie à conjugaison médicament-Fc (DFC). Contrairement aux vaccins, elle ne repose pas sur une réponse immunitaire, offrant potentiellement une protection indépendamment de l'état immunitaire. Cette thérapie a montré des résultats prometteurs dans la prévention des infections par les souches saisonnières et pandémiques de la grippe A et B.
Cidara Therapeutics (Nasdaq: CDTX) hat den Start seiner Phase 2b NAVIGATE-Studie bekannt gegeben, die CD388 zur Prävention von saisonaler Influenza bewertet. Die Studie hat mit der Dosierung der ersten Probanden begonnen und zielt darauf ab, 5.000 gesunde, nicht geimpfte Erwachsene an klinischen Standorten in den USA und im Vereinigten Königreich einzuschreiben.
Die Studie ist als randomisierte, doppelblinde, kontrollierte Studie mit drei CD388-Dosierungsgruppen und einer Placebo-Gruppe konzipiert. Die Probanden erhalten zu Beginn der Grippesaison eine einmalige Dosis und werden auf Durchbruchfälle überwacht. Die Studie vergleicht die Raten von im Labor und klinisch bestätigten Influenzafällen zwischen den CD388- und Placebo-Gruppen.
CD388, das mit der proprietären Cloudbreak®-Plattform von Cidara entwickelt wurde, ist eine Drug-Fc-Konjugat (DFC) Immuntherapie. Im Gegensatz zu Impfstoffen ist es nicht auf eine Immunreaktion angewiesen und könnte Schutz unabhängig vom Immunstatus bieten. Die Therapie hat vielversprechende Ergebnisse bei der Prävention von Infektionen durch saisonale und pandemische Stämme von Influenza A und B gezeigt.
- Initiation of Phase 2b NAVIGATE trial for CD388, a potential influenza prevention therapy
- Large-scale study with 5,000 subjects across US and UK sites
- CD388's potential to work regardless of immune status
- Demonstrated potential to prevent both seasonal and pandemic influenza A and B strains
- None.
The Phase 2b trial will enroll 5,000 subjects across clinical sites in the US and UK
SAN DIEGO, Sept. 23, 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 the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of influenza during the current flu season.
The Phase 2b clinical trial is a randomized, double blind, controlled trial targeting 5,000 healthy unvaccinated adult subjects who are not at risk of complications from influenza. Three CD388 dose groups or placebo will be administered to subjects as a single dose at the beginning of the influenza season. Subjects will then be followed for the remainder of the influenza season to monitor for breakthrough cases. Rates of laboratory and clinically confirmed influenza will be compared between subjects receiving the various single doses of CD388 or placebo. The study will include sites in the US and UK.
“Effective new options are needed to prevent influenza, particularly for people who do not respond well to seasonal flu vaccines,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara Therapeutics. “Since CD388 is not a vaccine, its activity does not rely upon an immune response and is thereby expected to work regardless of immune status. In addition, CD388 has demonstrated the potential to prevent infection by both seasonal and pandemic strains of influenza A and B. We are pleased to reach this important milestone, and look forward to monitoring the progress of the NAVIGATE study as this year’s flu season unfolds.”
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 plans to advance CD388 into a Phase 2b trial in the 2024 Northern Hemisphere influenza season. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which will be developed 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,” “may,” “believe,” “plan,” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to plans and timing for the Phase 2b NAVIGATE clinical trial for CD388, including the speed of patient enrollment and the frequency of influenza infections observed. 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 preclinical or clinical trials, unanticipated impacts of the workforce reduction, difficulties in obtaining potential partners or other obstacles to clinical development. 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 Securities and Exchange Commission. 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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FAQ
What is the purpose of Cidara Therapeutics' Phase 2b NAVIGATE trial for CD388?
How many subjects will be enrolled in Cidara's (CDTX) Phase 2b NAVIGATE trial?
What makes CD388 different from traditional flu vaccines?
Where will Cidara Therapeutics (CDTX) conduct the Phase 2b NAVIGATE trial for CD388?
