Cidara Therapeutics Presents Data on CD388 from its Phase 2b NAVIGATE Trial and Preclinical Studies Against H5N1 at ISRV’s 8th AVG and 3rd IMRP 2025 Meeting
Cidara Therapeutics (NASDAQ:CDTX) presented significant data on CD388, its non-vaccine influenza preventative, at the International Society for Respiratory Viruses conference in Singapore. The company showcased two key presentations: results from the Phase 2b NAVIGATE trial and preclinical studies against H5N1.
The NAVIGATE study, involving over 5,000 healthy adults, demonstrated that a single subcutaneous dose of CD388 provided statistically significant protection against influenza illness over 24 weeks. The trial tested three dosage levels (150mg, 300mg, and 450mg) against placebo.
In preclinical studies, CD388 showed promising results against H5N1 (bird flu) in ferret models, with a 10 mg/kg dose achieving 100% survival rate and a 3 mg/kg dose protecting 75% of ferrets from death. The treatment significantly reduced viral titers and prevented viral spread to other organs.
Cidara Therapeutics (NASDAQ:CDTX) ha presentato dati significativi su CD388, il suo preventivo antinfluenzale non vaccinale, alla conferenza della International Society for Respiratory Viruses a Singapore. L'azienda ha messo in evidenza due presentazioni chiave: i risultati del triale di fase 2b NAVIGATE e studi preclinici contro l'H5N1.
Lo studio NAVIGATE, che ha coinvolto oltre 5.000 adulti sani, ha dimostrato che una singola dose sottocutanea di CD388 offre una protezione statisticamente significativa dall'influenza per 24 settimane. Il trial ha testato tre livelli di dosaggio (150 mg, 300 mg e 450 mg) rispetto al placebo.
Negli studi preclinici, CD388 ha mostrato risultati promettenti contro l'H5N1 (influenza aviaria) nei modelli di furetti, con una dose di 10 mg/kg che ha ottenuto un tasso di sopravvivenza del 100% e una dose di 3 mg/kg che ha protetto il 75% dei furetti dalla morte. Il trattamento ha ridotto significativamente i titoli virali e ha impedito la diffusione del virus ad altri organi.
Cidara Therapeutics (NASDAQ:CDTX) presentó datos significativos sobre CD388, su preventivo no vacunado contra la gripe, en la conferencia de la International Society for Respiratory Viruses en Singapur. La empresa mostró dos presentaciones clave: resultados del ensayo de fase 2b NAVIGATE y estudios preclínicos contra el H5N1.
El estudio NAVIGATE, que incluyó a más de 5,000 adultos sanos, demostró que una dosis única subcutánea de CD388 proporcionó una protección statistically significativa contra la gripe durante 24 semanas. El ensayo probó tres niveles de dosis (150 mg, 300 mg y 450 mg) frente a placebo.
En los estudios preclínicos, CD388 mostró resultados prometedores contra el H5N1 ( gripe aviar) en modelos de hurones, con una dosis de 10 mg/kg que logró una tasa de supervivencia del 100% y una dosis de 3 mg/kg que protegió al 75% de los hurones de la muerte. El tratamiento redujo significativamente los títulos virales y evitó la propagación del virus a otros órganos.
Cidara Therapeutics (NASDAQ:CDTX)가 싱가포르에서 열린 호흡기 바이러스 국제학회에서 비백신형 독감 예방제 CD388에 대한 중요한 데이터를 발표했습니다. 회사는 두 가지 주요 발표를 선보였습니다: 2b 단계 NAVIGATE 시험의 결과와 H5N1에 대한 전임상 연구.
NAVIGATE 연구는 5,000명 이상의 건강한 성인을 대상으로 하였으며, CD388의 단일 피하 주사가 24주간 독감 질환으로부터 통계적으로 유의한 보호를 제공함을 입증했습니다. 이 시험은 위약과 비교하여 3개의 용량 수준(150 mg, 300 mg, 450 mg)을 시험했습니다.
전임상 연구에서 CD388은 H5N1(조류 독감)에 대해 여우모형에서 유망한 결과를 보였으며, 10 mg/kg 용량에서 100% 생존율을, 3 mg/kg 용량에서 75%의 여우를 사망으로부터 보호했습니다. 치료는 바이러스 혈증을 크게 감소시키고 바이러스가 다른 장기로 확산되는 것을 방지했습니다.
Cidara Therapeutics (NASDAQ:CDTX) a présenté des données significatives sur CD388, son préventif non vaccinal contre la grippe, lors de la conférence de l’International Society for Respiratory Viruses à Singapour. L’entreprise a mis en avant deux présentations clés : les résultats de l’essai Phase 2b NAVIGATE et des études précliniques contre le H5N1.
L’étude NAVIGATE, impliquant plus de 5 000 adultes sains, a démontré qu’une dose unique sous-cutanée de CD388 offrait une protection statistiquement significative contre la grippe pendant 24 semaines. L’essai a testé trois niveaux de dosage (150 mg, 300 mg et 450 mg) par rapport au placebo.
Dans les études précliniques, CD388 a montré des résultats prometteurs contre le H5N1 (grippe aviaire) chez des furets, avec une dose de 10 mg/kg atteignant un taux de survie de 100% et une dose de 3 mg/kg protégeant 75% des furets de la mort. Le traitement a réduit significativement les titres viraux et a empêché la propagation du virus vers d’autres organes.
Cidara Therapeutics (NASDAQ:CDTX) hat auf der Konferenz der International Society for Respiratory Viruses in Singapur signifikante Daten zu CD388 präsentiert, dem nicht-impfstoffbasierten Grippepräventionsmittel des Unternehmens. Das Unternehmen stellte zwei zentrale Präsentationen vor: Ergebnisse der Phase-2b-NAVIGATE-Studie und präklinische Studien gegen H5N1.
Die NAVIGATE-Studie, an der über 5.000 gesunde Erwachsene teilnahmen, zeigte, dass eine einzige subkutane Dosis von CD388 einen statistisch signifikanten Schutz gegen Grippe über 24 Wochen bietet. Die Studie testete drei Dosierungsstufen (150 mg, 300 mg und 450 mg) im Vergleich zu Placebo.
In präklinischen Studien zeigte CD388 vielversprechende Ergebnisse gegen H5N1 (Vogelgrippe) in Forscherferret-Modellen, wobei eine Dosis von 10 mg/kg eine 100%-ige Überlebensrate erreichte und eine Dosis von 3 mg/kg 75% der ferrets vor dem Tod schützte. Die Behandlung senkte deutlich die Viruslast und verhinderte die Ausbreitung des Virus auf andere Organe.
Cidara Therapeutics (NASDAQ:CDTX) قدمت بيانات مهمة حول CD388، وقايتها من الإنفلونزا بدون لقاح، في مؤتمر الجمعية الدولية لفيروسات الجهاز التنفسي في سنغافورة. عرضت الشركة عرضين رئيسيين: نتائج تجربة المرحلة 2b NAVIGATE والدراسات قبل السريرية ضد H5N1.
أظهرت دراسة NAVIGATE، التي شملت أكثر من 5,000 بالغ صحي، أن جرعة واحدة تحت الجلد من CD388 وفرت حماية ذات دلالة إحصائية من الإنفلونزا طوال 24 أسبوعاً. اختبرت التجربة ثلاث مستويات جرعات (150 ملغ، 300 ملغ، 450 ملغ) مقارنةً بالدواء الوهمي.
في الدراسات قبل السريرية، أظهرت CD388 نتائج واعدة ضد H5N1 (إنفلونزا الطيور) في نماذج فئران فِرْت، مع جرعة 10 mg/kg حققت معدل بقاء بنسبة 100%، وجرعة 3 mg/kg أمنت 75% من الفئران من الموت. خفض العلاج بشكل ملحوظ أحجام الفيروس ومنع انتشار الفيروس إلى أعضاء أخرى.
Cidara Therapeutics (NASDAQ:CDTX) 在新加坡举行的呼吸道病毒国际学会会议上公布了关于 CD388 的重要数据——这是其非疫苗性流感预防药物。公司展示了两场关键报告：Phase 2b NAVIGATE 试验的结果以及针对 H5N1 的前临床研究。
NAVIGATE 研究涉及超过 5,000 名健康成人，显示单次皮下注射 CD388 在 24 周内对流感疾病具有统计学意义的保护作用。试验比较了三种剂量水平（150 mg、300 mg、450 mg）与安慰剂。
在前临床研究中，CD388 对 H5N1（禽流感）在雪貂模型中显示出有希望的结果，10 mg/kg剂量实现 100% 存活率，3 mg/kg剂量保护 75% 的雪貂免于死亡。该治疗显著降低病毒滴度，并阻止病毒传播至其他器官。
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Insights
Cidara's CD388 shows promising Phase 2b results for flu prevention and potential protection against pandemic H5N1 strain.
Cidara's presentations at the ISRV conference provide significant validation for their lead candidate CD388, a drug-Fc conjugate designed to provide season-long influenza protection with a single dose. The Phase 2b NAVIGATE trial, which enrolled over 5,000 healthy adults, achieved its primary endpoint by demonstrating statistically significant protection against laboratory-confirmed influenza over a 24-week period - essentially covering an entire flu season with one administration.
What makes CD388 particularly noteworthy is its novel mechanism as a non-vaccine preventative. Unlike traditional vaccines that require annual reformulation and administration, CD388 represents a fundamentally different approach through Cidara's Cloudbreak platform. The successful Phase 2b results suggest this approach is viable, potentially creating a new product category in the $5+ billion influenza prevention market.
Perhaps more strategically important are the preclinical results against H5N1 (avian influenza), which demonstrated 100% survival at the higher dose in ferret models. With increasing concerns about pandemic preparedness, especially for highly pathogenic strains like H5N1 with mortality rates exceeding 50% in humans, these results position CD388 as a potential tool for both seasonal and pandemic influenza protection. The data showing reduced viral load in both upper and lower respiratory tracts and prevention of neuroinvasion demonstrates a comprehensive protective effect.
This represents meaningful clinical progress for Cidara, suggesting CD388 could potentially address both the commercial seasonal influenza market and secure government stockpiling contracts for pandemic preparedness. The company's presentation of this data at a respected scientific conference provides external validation of their approach and sets the stage for continued development toward Phase 3 trials.
- Efficacy and safety results from successful NAVIGATE Phase 2b trial of CD388 for prevention of influenza illness featured in late-breaking presentation
- Preclinical data demonstrating potential efficacy of CD388 to prevent H5N1 infection featured in oral presentation
SAN DIEGO, Sept. 17, 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 two presentations during the International Society for Respiratory Viruses (ISRV) 8th AntiViral Group (AVG) Meeting and 3rd International Meeting on Respiratory Pathogens (IMRP). The conference is taking place September 17-20, 2025, in Singapore. The presentations highlight efficacy and safety data on CD388, Cidara’s non-vaccine influenza preventative, from the successful Phase 2b NAVIGATE study, as well as preclinical data on the efficacy of CD388 to prevent infection in H5N1 animal models.
“These two oral presentations further highlight the potential of CD388 to provide season long protection against influenza as well as activity against highly pathogenic pandemic strains like H5N1,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “The Phase 2b presentation represents the first description of CD388 NAVIGATE study data in an academic setting. Importantly, the preclinical results of CD388 in a ferret model suggests that CD388 has the potential to provide prophylactic protection from this potentially deadly viral infection. We look forward to disclosing additional details on the safety, PK and virology data from our Phase 2b NAVIGATE study at upcoming conferences this fall.”
Late-Breaking Abstract Title: NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Trial to Evaluate the Efficacy and Safety of CD388 for Prevention of Influenza Illness in Healthy Adults
Presenter: Rick Bright, Ph.D. Bright Global Health, Cidara Therapeutics
Session: AVG Session 3
Session Date and Time: Wednesday, September 17, 2025, 3:50 p.m. – 4:05 p.m. SGT
Summary: The Phase 2b NAVIGATE study was conducted to evaluate the safety and efficacy of a single subcutaneous dose of CD388 for the prevention of laboratory-confirmed influenza in healthy, unvaccinated adults. Over 5,000 adults aged 18-64 years old without risk factors for complications from influenza were randomized to receive CD388 (150mg, 300mg, or 450mg) or placebo. The primary endpoint was preventative efficacy over 24 weeks against laboratory confirmed influenza. Overall, CD388 demonstrated it was well tolerated with statistically significant, single-dose protection against influenza illness over 24 weeks.
Abstract Title: A Single Prophylactic Dose of CD388 Provides Protection Against Highly Pathogenic Bovine-Origin Influenza A (H5N1) Virus in the Ferret Model
Presenter: Andreev Konstantin, Ph.D. St. Jude Children’s Research Hospital
Session: Parallel Session 2 (Track 1)
Session Date and Time: Friday, September 19, 2025, 10:30 a.m. – 12:30 p.m. SGT
Summary: The prophylactic efficacy of CD388 was evaluated against lethal A (H5N1) infection in ferrets. Ferrets untreated with CD388 displayed pronounced weight loss, neurological symptoms, and survival endpoints at 4-8 days post-inoculation. A single subcutaneous dose of CD388 at 3 mg/kg administered 24 hours before H5N1 virus inoculation protected
The abstracts from Cidara’s two presentations will be available on the Cidara corporate website under “publications” following the meeting.
Cidara will also be hosting a lunch symposium at the conference on Friday, September 19, 2025, from 1:00 – 1:45 p.m. SGT in the Grand Ballroom 1, Level 4, Waterfront Conference Centre. The symposium is titled “CD388: A New Modality for Broad Influenza Protection in Healthy and High-Risk Populations,” and will be co-chaired by Frederick G. Hayden, M.D., FACP and Rick Bright, Ph.D., along with Cidara’s SVP, clinical operations, Corrina Pavetto, and Cidara’s chief scientific officer, Les Tari, Ph.D. as speakers.
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, whether the Phase 2b NAVIGATE Trial results will be predictive of efficacy or safety in a Phase 3 trial, and whether the results of a preclinical trial in a ferret model may predict the activity of CD388 against the H5N1 strain or any strain of pandemic influenza 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 associated with the enrollment of patients 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.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
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FAQ
What were the key results of Cidara's Phase 2b NAVIGATE trial for CD388?
How effective was CD388 against H5N1 (bird flu) in preclinical studies?
How many participants were involved in Cidara's NAVIGATE trial for CD388?
What is CD388 and how is it different from traditional flu vaccines?
