Cidara Therapeutics Announces Two Presentations on Drug-Fc Conjugate, CD388, at IDWeek 2024
Cidara Therapeutics announced two presentations on its drug-Fc conjugate, CD388, at IDWeek 2024. The presentations will highlight clinical data on safety, pharmacokinetics, and prophylactic activity of CD388 for influenza prevention. An oral presentation will discuss CD388's prophylactic activity in a Phase 2a human challenge study, where a single dose prevented symptomatic disease in subjects who seroconverted after influenza challenge. A poster presentation will cover a study evaluating CD388's safety, tolerability, and pharmacokinetics in healthy subjects. Results showed rapid absorption, slow elimination, and potential for seasonal influenza prevention with one dose. No safety concerns or anti-drug antibody formation were observed, supporting annual use.
Cidara Therapeutics ha annunciato due presentazioni sul suo coniugato farmaco-Fc, CD388, durante l'IDWeek 2024. Le presentazioni metteranno in evidenza dati clinici su sicurezza, farmacocinetica e attività profilattica di CD388 per la prevenzione dell'influenza. Una presentazione orale discuterà dell'attività profilattica di CD388 in uno studio di sfida umana di Fase 2a, dove una singola dose ha prevenuto la malattia sintomatica nei soggetti che hanno seroconvertito dopo la sfida con l'influenza. Una presentazione poster tratterà uno studio che valuta la sicurezza, la tollerabilità e la farmacocinetica di CD388 in soggetti sani. I risultati hanno mostrato un'assorbimento rapido, un'eliminazione lenta e il potenziale per la prevenzione stagionale dell'influenza con una sola dose. Non sono stati osservati problemi di sicurezza né formazione di anticorpi anti-farmaco, a sostegno dell'uso annuale.
Cidara Therapeutics anunció dos presentaciones sobre su conjugado de fármaco-Fc, CD388, en IDWeek 2024. Las presentaciones destacarán datos clínicos sobre seguridad, farmacocinética y actividad profiláctica de CD388 para la prevención de la influenza. Una presentación oral discutirá la actividad profiláctica de CD388 en un estudio de desafío humano de Fase 2a, donde una sola dosis previno la enfermedad sintomática en sujetos que seroconvirtieron después del desafío de influenza. Una presentación de póster cubrirá un estudio que evalúa la seguridad, tolerabilidad y farmacocinética de CD388 en sujetos sanos. Los resultados mostraron una rápida absorción, una lenta eliminación y potencial para la prevención estacional de la influenza con una sola dosis. No se observaron preocupaciones de seguridad ni formación de anticuerpos anti-fármaco, lo que apoya el uso anual.
시다라 테라퓨틱스(Cidara Therapeutics)가 IDWeek 2024에서 약물-Fc 컨쥬게이트 CD388에 대한 두 가지 발표를 했습니다. 발표에서는 CD388의 인플루엔자 예방을 위한 안전성, 약물 동태학 및 예방 활동에 대한 임상 데이터가 강조될 것입니다. 구두 발표에서는 CD388의 예방 활동에 대한 2a상 인간 도전 연구를 논의하며, 단일 투여가 인플루엔자 도전 후 면역 반응이 발생한 피험자에서 증상성 질병을 예방한 사례에 대해 설명합니다. 포스터 발표에서는 건강한 피험자에서 CD388의 안전성, 내약성 및 약물 동태학을 평가하는 연구를 다룹니다. 결과는 빠른 흡수, 느린 배설, 한 번의 투여로 계절 인플루엔자 예방 가능성을 보여주었습니다. 안전성 문제나 약물 항체 형성은 관찰되지 않아 연간 사용을 지원합니다.
Cidara Therapeutics a annoncé deux présentations sur son conjugant médicament-Fc, CD388, lors de l'IDWeek 2024. Les présentations mettront en évidence les données cliniques sur la sécurité, la pharmacocinétique et l'activité prophylactique de CD388 pour la prévention de la grippe. Une présentation orale abordera l'activité prophylactique de CD388 dans une étude de défi humain de Phase 2a, où une seule dose a prévenu la maladie symptomatic chez des sujets ayant séroconverti après le défi de la grippe. Une présentation par affiche couvrira une étude évaluant la sécurité, la tolérabilité et la pharmacocinétique de CD388 chez des sujets sains. Les résultats ont montré une absorption rapide, une élimination lente et un potentiel de prévention saisonnière de la grippe avec une seule dose. Aucun problème de sécurité ni formation d'anticorps anti-médicament n'ont été observés, soutenant l'utilisation annuelle.
Cidara Therapeutics kündigte zwei Präsentationen zu ihrem Medikament-Fc-Konjugat CD388 auf der IDWeek 2024 an. Die Präsentationen werden klinische Daten zu Sicherheit, Pharmakokinetik und prophylaktischer Aktivität von CD388 zur Influenza-Prävention hervorheben. Eine mündliche Präsentation wird die prophylaktische Aktivität von CD388 in einer Phase 2a-Human-Challenge-Studie erörtern, in der eine Einzeldosis die symtomatischen Erkrankungen bei Probanden verhinderte, die nach der Influenza-Herausforderung serokonvertiert haben. Eine Posterpräsentation wird eine Studie vorstellen, die die Sicherheit, Verträglichkeit und Pharmakokinetik von CD388 bei gesunden Probanden bewertet. Die Ergebnisse zeigten eine schnelle Absorption, langsame Elimination und das Potenzial zur saisonalen Influenza-Prävention mit einer einzigen Dosis. Es wurden keine Sicherheitsbedenken oder die Bildung von Anti-Arzneimittel-Antikörpern festgestellt, was die jährliche Anwendung unterstützt.
- CD388 demonstrated prophylactic activity against influenza in a Phase 2a human challenge study
- Single dose of CD388 showed potential for season-long prevention of influenza
- CD388 exhibited rapid absorption and slow elimination, supporting one-dose-per-season administration
- No anti-drug antibody formation observed with repeat administration, supporting annual use
- No safety concerns were noted in the clinical studies
- None.
SAN DIEGO, Oct. 16, 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 upcoming presentations at IDWeek 2024, to be held October 16–19, 2024 in Los Angeles, CA. The presentations will highlight clinical data on the safety, pharmacokinetics, and prophylactic activity of Cidara’s clinical-stage influenza DFC asset, CD388.
“We are pleased to share these clinical results at this year’s IDWeek, which underscore the potential for CD388 as an effective and well-tolerated DFC for single-dose, season-long prevention of influenza,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We hope to share the results of our ongoing NAVIGATE Phase 2b clinical trial of CD388 at next year’s meeting.”
Oral Presentation
| Title: | CD388, a Novel Drug-Fc Conjugate (DFC), Demonstrates Prophylactic Activity in an Influenza Human Challenge Model |
| Presenter: | Taylor Sandison, MD, MPH, Cidara Therapeutics |
| Session: | Inhaling Insight: Advancements in Respiratory Viral Infections |
| Session Location: | 408A |
| Date/Time: | Saturday, October 19, 2:21–2:39 PM Pacific Time (PT) |
| Summary: | An analysis was conducted to determine prophylactic activity of CD388 against influenza disease in a Phase 2a human challenge study. The study found that a single subcutaneous dose of CD388 administered 5 days prior to influenza challenge was effective in preventing symptomatic disease among those who demonstrated seroconversion following influenza challenge. |
Poster and Rapid-Fire Presentation:
| Title: | Single-Dose and Repeat Single-Dose Ascending Dose Study Evaluating Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza |
| Presenter: | Shawn Flanagan, Ph.D., Cidara Therapeutics |
| Session: | Novel Agents |
| Session Location: | Halls JK |
| Date/Time: | Friday, October 18, 2024, 12:15–1:30 PM (12:15 - 12:45 for rapid fire presentation) PT |
| Summary: | The safety, tolerability, and pharmacokinetics (PK) of CD388 were evaluated in healthy subjects administered either intramuscularly or subcutaneously with varying dosages of the drug. Absorption of CD388 was rapid both intramuscularly and subcutaneously, and elimination was slow, indicating that seasonal influenza prevention could be achieved with one dose per season. There was a lack of anti-drug antibody formation with repeat administration, supporting annual use of CD388, and no safety concerns were noted. |
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,” “may,” “believe,” “plan,” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to plans and timing for initiating a Phase 2b clinical trial for CD388 and whether the safety and pharmacokinetic data observed in clinical trials to date will be confirmed with larger studies in different patient populations. 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.
INVESTOR CONTACT:
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(212) 915-2578
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