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Cidara Therapeutics Announces Presentations Highlighting Phase 1 and Phase 2a Clinical Data on CD388 at ESCMID 2024

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Cidara Therapeutics announced data presentations at ESCMID 2024 on CD388, highlighting Phase 1 and Phase 2a clinical data. The Phase 2a study showed CD388 was well-tolerated with significant antiviral effects in healthy volunteers challenged with influenza. The Phase 1 study demonstrated an extended half-life of 6-8 weeks, indicating potential for seasonal influenza prevention.
Cidara Therapeutics ha annunciato la presentazione di dati all'ESCMID 2024 su CD388, evidenziando i dati clinici della Fase 1 e della Fase 2a. Lo studio di Fase 2a ha mostrato che CD388 è stato ben tollerato e ha avuto effetti antivirali significativi in volontari sani sfidati con l'influenza. Lo studio di Fase 1 ha dimostrato una emivita prolungata di 6-8 settimane, indicando un potenziale per la prevenzione dell'influenza stagionale.
Cidara Therapeutics anunció la presentación de datos en el ESCMID 2024 sobre CD388, destacando los datos clínicos de la Fase 1 y Fase 2a. El estudio de Fase 2a mostró que CD388 fue bien tolerado y tuvo efectos antivirales significativos en voluntarios sanos expuestos a la influenza. El estudio de Fase 1 demostró una vida media prolongada de 6-8 semanas, sugiriendo un potencial para la prevención de la influenza estacional.
Cidara Therapeutics는 ESCMID 2024에서 CD388에 대한 데이터 발표를 발표했습니다. 연구는 1상 및 2a상 임상 데이터를 강조했습니다. 2a상 연구에서 건강한 자원 봉사자들에게 독감에 도전하면서 CD388은 잘 견디고 현저한 항바이러스 효과를 보였습니다. 1상 연구는 6-8주의 긴 반감기를 보여주었으며, 이는 계절 인플루엔자 예방에 대한 잠재력을 나타냅니다.
Cidara Therapeutics a annoncé des présentations de données lors de l'ESCMID 2024 sur le CD388, soulignant les données cliniques des phases 1 et 2a. L'étude de phase 2a a montré que le CD388 était bien toléré avec des effets antiviraux significatifs chez les volontaires sains exposés à la grippe. L'étude de phase 1 a démontré une demi-vie prolongée de 6 à 8 semaines, indiquant un potentiel pour la prévention de la grippe saisonnière.
Cidara Therapeutics hat Datenpräsentationen auf dem ESCMID 2024 über CD388 angekündigt, die auf die klinischen Daten der Phase 1 und Phase 2a hinweisen. Die Studie der Phase 2a zeigte, dass CD388 gut verträglich war und signifikante antivirale Effekte bei gesunden Freiwilligen hatte, die mit Influenza konfrontiert waren. Die Studie der Phase 1 zeigte eine verlängerte Halbwertszeit von 6-8 Wochen, was das Potenzial für die Prävention der saisonalen Grippe anzeigt.
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SAN DIEGO, April 26, 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 two poster presentations highlighting data on CD388 at the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference, being held April 27-30, 2024 in Barcelona, Spain.

The first presentation highlights data from the Phase 2a study of CD388, showing the DFC was well tolerated and demonstrated statistically significant antiviral effects when administered as a single subcutaneous dose in healthy volunteers challenged with influenza. The second presentation highlights data from a Phase 1 single ascending dose study of CD388 which showed the drug has an extended half-life of 6-8 weeks. These data underscore the potential of CD388 to provide patients with seasonal influenza prevention.   

“Data presentations at the ESCMID 2024 conference support our belief that CD388 has the potential to provide season-long, universal protection from influenza,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. “We look forward to continuing to advance this candidate through Phase 2b development after our recent reacquisition from Johnson & Johnson and move closer to providing additional preventative options to patients.”

Presentation details:
Title: Prophylactic efficacy of CD388, a novel drug-Fc conjugate (DFC), in an influenza A/H3N2 human challenge model
Presenter: Roxana E. Rojas
Date/Time: April 27, 2024, 12pm CEST

Title: CD388, a drug-Fc conjugate, shows long half-life in early clinical studies
Presenter: Ruben Faelens
Date/Time: April 27, 2024, 12pm CEST

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 is developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases. The Company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including DFCs from its proprietary Cloudbreak® platform targeting oncologic, viral and autoimmune diseases. 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,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether the CD388 Phase 2a data will be replicated in the Phase 2b clinical trial and whether CD388 will be shown to provide season-long, universal protection from influenza. 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 pre-clinical or clinical trials, delays in action by regulatory authorities, and obstacles on the enrollment of patients or other aspects of CD388 development. 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, 2023, 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
britchie@lifesciadvisors.com

MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com 


FAQ

What data was highlighted in the Phase 2a study of CD388?

The Phase 2a study of CD388 showed the drug was well tolerated and demonstrated statistically significant antiviral effects in healthy volunteers challenged with influenza.

What was the outcome of the Phase 1 single ascending dose study of CD388?

The Phase 1 single ascending dose study of CD388 showed the drug has an extended half-life of 6-8 weeks.

When and where will the data presentations on CD388 be held?

The data presentations on CD388 will be held at the 34th ESCMID conference in Barcelona, Spain on April 27, 2024.

Who is the President and CEO of Cidara Therapeutics?

Jeffrey Stein, Ph.D. is the President and CEO of Cidara Therapeutics.

What is the potential of CD388 according to Cidara Therapeutics?

Cidara Therapeutics believes that CD388 has the potential to provide season-long, universal protection from influenza.

Cidara Therapeutics, Inc.

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