Cidara Therapeutics Announces First Participants Dosed in Phase 3 ANCHOR Trial Evaluating CD388 for the Prevention of Seasonal Influenza in High-Risk Populations
Cidara Therapeutics (Nasdaq: CDTX) has initiated dosing in its Phase 3 ANCHOR trial evaluating CD388, a novel non-vaccine preventative treatment for seasonal influenza. The trial aims to enroll 6,000 participants across high-risk populations, including adults over 65 and individuals with compromised immune systems or co-morbidities.
CD388 is administered as a one-time 450-milligram subcutaneous dose and, unlike traditional vaccines, does not rely on an immune response for effectiveness. The study follows positive Phase 2b NAVIGATE trial results and will include an interim analysis after the Northern Hemisphere flu season. The company has over $500 million in cash to fund the Phase 3 program through completion.
Cidara Therapeutics (Nasdaq: CDTX) ha avviato la dosizzazione nel suo studio di fase 3 ANCHOR che valuta CD388, un nuovo trattamento preventivo non vaccinale per l'influenza stagionale. Lo studio mira a reclutare 6.000 partecipanti tra le popolazioni ad alto rischio, tra cui adulti oltre 65 anni e persone con sistemi immunitari compromessi o comorbidità. CD388 viene somministrato come una dose sottocutanea unica di 450 milligrammi e, a differenza dei vaccini tradizionali, non dipende da una risposta immunitaria per l'efficacia. Lo studio segue i positivi risultati della fase 2b NAVIGATE e includerà un'analisi interima dopo la stagione influenzale dell'emisfero settentrionale. L'azienda dispone di oltre 500 milioni di dollari in cassa per finanziare il programma di fase 3 fino al completamento.
Cidara Therapeutics (Nasdaq: CDTX) ha iniciado la dosificación en su ensayo de Fase 3 ANCHOR que evalúa CD388, un nuevo tratamiento preventivo no vacunas para la gripe estacional. El ensayo pretende reclutar 6.000 participantes entre poblaciones de alto riesgo, incluidas personas mayores de 65 años y personas con sistemas inmunitarios comprometidos o comorbilidades. CD388 se administra como una dosis única subcutánea de 450 miligramos y, a diferencia de las vacunas tradicionales, no depende de una respuesta inmunitaria para su eficacia. El estudio sigue los resultados positivos de la fase 2b NAVIGATE y mostrará un análisis intermedio tras la temporada de gripe del hemisferio norte. La empresa tiene más de 500 millones de dólares en efectivo para financiar el programa de fase 3 hasta su finalización.
Cidara Therapeutics (Nasdaq: CDTX)는 계절성 독감에 대한 새로운 비백신 예방 치료제인 CD388를 평가하는 3상 ANCHOR 시험에서 투약을 시작했습니다. 이 시험의 목표는 6,000명의 고위험 인구에서 참가자를 모집하는 것이며, 65세 이상 성인 및 면역 시스템이 약화되었거나 합병증이 있는 개인이 포함됩니다. CD388은 한 번의 450밀리그램 피하 주사로 투여되며, 기존 백신과 달리 효능에 면역 반응에 의존하지 않습니다. 이 연구는 2b NAVIGATE의 긍정적 결과를 바탕으로 하며 북반구의 독감 시즌 이후 중간 분석을 포함합니다. 이 회사는 5억 달러 이상의 현금을 보유하고 있어 3상 프로그램을 완료까지 자금을 지원합니다.
Cidara Therapeutics (Nasdaq : CDTX) a commencé l'administration dans son essai de phase 3 ANCHOR évaluant CD388, un nouveau traitement préventif non vaccinatoire pour la grippe saisonnière. L'essai vise à recruter 6 000 participants parmi les populations à haut risque, notamment les adultes de plus de 65 ans et les personnes dont le système immunitaire est compromis ou présentant des comorbidités. CD388 est administré sous forme d'une dose unique sous-cutanée de 450 milligrammes et, contrairement aux vaccins traditionnels, ne dépend pas d'une réponse immunitaire pour son efficacité. L'étude s'appuie sur les résultats positifs de la phase 2b NAVIGATE et comprendra une analyse intermédiaire après la saison de grippe de l'hémisphère nord. L'entreprise dispose de plus de 500 millions de dollars en liquidités pour financer le programme de phase 3 jusqu'à son achèvement.
Cidara Therapeutics (Nasdaq: CDTX) hat mit der Dosierung in ihrer Phase-3-ANCHOR-Studie begonnen, die CD388, eine neuartige nicht-impfstoffbasierte vorbeugende Behandlung gegen saisonale Grippe, bewertet. Die Studie zielt darauf ab, 6.000 Teilnehmer aus Hochrisikogruppen zu rekrutieren, darunter Erwachsene über 65 Jahre sowie Personen mit geschwächtem Immunsystem oder Begleiterkrankungen. CD388 wird als eine einmalige subkutane Dosis von 450 Milligramm verabreicht und unterscheidet sich von herkömmlichen Impfstoffen dadurch, dass sie nicht auf eine Immunreaktion für die Wirksamkeit angewiesen ist. Die Studie baut auf den positiven Ergebnissen der Phase-2b NAVIGATE auf und wird nach der Grippesaison der Nordhalbkugel eine Zwischenanalyse umfassen. Das Unternehmen verfügt über mehr als 500 Millionen US-Dollar in bar, um das Phase-3-Programm bis zum Abschluss zu finanzieren.
Cidara Therapeutics (Nasdaq: CDTX) قد بدأت إعطاء الجرعات في تجربتها من المرحلة الثالثة ANCHOR التي تقيم CD388، وهو علاج وقائي جديد غير لقاح للإنفلونزا الموسمية. تهدف التجربة إلى تسجيل 6,000 مشارك من فئات عالية الخطورة، بما في ذلك البالغون الذين تجاوزوا 65 عامًا والأشخاص ذوو الجهاز المناعي الضعيف أو المصابين بأمراض مصاحبة. يتم إعطاء CD388 كجرعة تحت جلديه أحادية بوزن 450 ملغ، وبخلاف اللقاحات التقليدية، لا يعتمد فعاليته على استجابة مناعية. تستند الدراسة إلى نتائج إيجابية من تجربة المرحلة 2b NAVIGATE وستتضمن تحليلًا وسيطيًا بعد موسم الإنفلونزا في النصف الشمالي من الكرة الأرضية. لدى الشركة أكثر من نصف مليار دولار نقدًا لتمويل برنامج المرحلة 3 حتى الانتهاء.
Cidara Therapeutics（纳斯达克：CDTX） 已在其3期 ANCHOR 试验中开始给药，评估 CD388，一种用于季节性流感的新型非疫苗预防治疗。试验旨在在高风险人群中招募 6,000 名参与者，包括65岁以上的成年人以及免疫系统受损或合并症患者。CD388 以一次性 450 毫克皮下注射给药，与传统疫苗不同，效果不依赖免疫反应。研究基于2b阶段 NAVIGATE 的积极结果，并将在北半球流感季结束后进行中期分析。公司手头拥有超过 5亿美元现金，足以资助3期项目直到完成。
- Strong cash position of over $500 million to fund Phase 3 program
- Positive results from Phase 2b NAVIGATE trial in healthy adults
- Single Phase 3 trial could be sufficient for BLA approval if successful
- FDA feedback led to expanded study population, increasing market potential
- Large-scale Phase 3 trial with 6,000 participants increases operational complexity
- Results dependent on seasonal flu patterns during trial period
Insights
Cidara's Phase 3 trial launch for CD388 marks significant progress toward a potential season-long influenza preventative for vulnerable populations.
Cidara's initiation of the Phase 3 ANCHOR trial represents a critical advancement in their clinical development program for CD388, a novel drug-Fc conjugate (DFC) designed to prevent seasonal influenza. Unlike traditional vaccines that require immune response, this non-vaccine approach could be transformative for vulnerable populations who typically respond poorly to vaccination.
The trial design shows considerable rigor with plans to enroll 6,000 participants across three key demographics: immune-compromised individuals (minimum 10%), high-risk people with comorbidities, and healthy adults over 65. This comprehensive population sampling will generate robust efficacy data across the spectrum of at-risk groups.
The company's strategic approach includes an interim analysis after the Northern Hemisphere flu season to refine enrollment parameters for the Southern Hemisphere phase – demonstrating scientific adaptability that could optimize study outcomes while potentially accelerating development timelines.
Most notably, CD388's mechanism as a one-time 450-milligram subcutaneous dose could provide season-long protection without requiring immune response, addressing a significant gap in current influenza prevention strategies. Their previous Phase 2b NAVIGATE results in healthy unvaccinated adults provide encouraging evidence supporting progression to this pivotal trial.
The regulatory strategy appears well-aligned with FDA expectations, as the company anticipates this single Phase 3 trial could support a BLA submission if successful. With
- Phase 3 study expected to enroll 6,000 participants starting in the Northern Hemisphere
- Participants will include adults over 65 years of age in addition to individuals with high-risk co-morbidities and immune compromised status
SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that the first participants have been dosed in its Phase 3 trial to evaluate the safety and efficacy of CD388, a non-vaccine preventative of seasonal influenza, in populations at high-risk for complications of influenza. Based on feedback from the FDA, the study population has been expanded to also include generally healthy adults over 65 years old with no specific co-morbidities in addition to other high-risk populations with certain comorbidities and immune compromised status.
“Dosing of the first participants in our Phase 3 trial marks an important milestone in the development of CD388, a potentially transformational preventative for those at high-risk of complications from influenza,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “The positive results from our recent Phase 2b NAVIGATE trial show that CD388 can be an important new option for preventing influenza illness in healthy, unvaccinated adults. As CD388 is not a vaccine, its activity does not rely on an immune response and has the potential to be an effective season-long flu preventative for those at risk from complications from influenza, those who do not respond to vaccines or those who prefer not to receive a vaccine. We look forward to enrolling the Phase 3 study, beginning today with the 2025 Northern Hemisphere influenza season.”
The Phase 3 trial, named ANCHOR, is a global, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of CD388 administered as a one-time 450-milligram subcutaneous dose in adults and adolescents. The company plans to enroll a minimum of
Further information on the ANCHOR trial can be found at https://clinicaltrials.gov/study/NCT07159763.
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel DFCs comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. 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 FDA. Cidara announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025. 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 benefits of and future plans for CD388, the expected timing, study design and target enrollment for the Phase 3 registrational trial of CD388, the potential to obtain BLA approval based on a single Phase 3 clinical trial and Cidara’s ability to fully fund the planned Phase 3 development program through completion. 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 associated with the enrollment of participants or other aspects of CD388 or other DFC development, having to use cash in ways other than as 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 Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 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's Phase 3 ANCHOR trial for CD388?
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