Cidara Therapeutics Announces Two Presentations on Innovative Drug-Fc Conjugate, CD388, at the 2024 OPTIONS XII for the Control of Influenza Conference
Cidara Therapeutics (Nasdaq: CDTX) announced two presentations on its influenza drug-Fc conjugate (DFC) candidate, CD388, at the OPTIONS XII conference in Brisbane, Australia. The presentations will highlight safety and pharmacokinetic data from clinical studies.
The oral presentation will summarize safety data from three CD388 clinical trials involving 108 subjects followed for 5-14 months. No dose-, route- or repeat-dose-related treatment-emergent adverse events were observed, supporting CD388's safety profile for single-dose seasonal influenza prevention.
The poster presentation will focus on pharmacokinetics and safety data from 27 healthy Japanese volunteers dosed subcutaneously with CD388. Results showed low-to-moderate variability across doses and were similar to previous studies in Western participants. No clinically significant treatment-emergent adverse events were reported.
Cidara Therapeutics (Nasdaq: CDTX) ha annunciato due presentazioni sul suo candidato farmaco-Fc coniugato contro l'influenza (DFC), CD388, durante la conferenza OPTIONS XII a Brisbane, Australia. Le presentazioni metteranno in evidenza i dati di sicurezza e farmacocinetica provenienti da studi clinici.
La presentazione orale riassumerà i dati di sicurezza provenienti da tre trial clinici su CD388, che hanno coinvolto 108 soggetti seguiti per un periodo di 5-14 mesi. Non sono stati osservati eventi avversi emergenti legati alla dose, alla via di somministrazione o alla somministrazione ripetuta, supportando il profilo di sicurezza di CD388 per la prevenzione dell'influenza stagionale con dose singola.
La presentazione del poster si concentrerà sulla farmacocinetica e sui dati di sicurezza di 27 volontari giapponesi sani a cui è stata somministrata CD388 per via sottocutanea. I risultati hanno mostrato una bassa-moderata variabilità tra le dosi e sono stati simili a studi precedenti condotti su partecipanti occidentali. Non sono stati riportati eventi avversi clinicamente significativi emergenti dal trattamento.
Cidara Therapeutics (Nasdaq: CDTX) anunció dos presentaciones sobre su candidato a fármaco-conjugado Fc para la influenza (DFC), CD388, en la conferencia OPTIONS XII en Brisbane, Australia. Las presentaciones destacarán los datos de seguridad y farmacocinética de estudios clínicos.
La presentación oral resumirá los datos de seguridad de tres ensayos clínicos de CD388 que involucraron a 108 sujetos seguidos durante 5-14 meses. No se observaron eventos adversos emergentes relacionados con la dosis, la vía de administración o la dosis repetida, lo que respalda el perfil de seguridad de CD388 para la prevención de la influenza estacional con una sola dosis.
La presentación del cartel se centrará en la farmacocinética y los datos de seguridad de 27 voluntarios japoneses sanos a los que se les administró CD388 por vía subcutánea. Los resultados mostraron baja a moderada variabilidad entre las dosis y fueron similares a estudios previos en participantes occidentales. No se informaron eventos adversos clínicamente significativos emergentes del tratamiento.
Cidara Therapeutics (Nasdaq: CDTX)는 호주 브리스번에서 열린 OPTIONS XII 회의에서 인플루엔자 약물 Fc 접합체 후보인 CD388에 대한 두 가지 발표를 했습니다. 이번 발표는 임상 연구에서의 안전성 및 약리학적 데이터를 강조할 것입니다.
구두 발표는 5-14개월 동안 추적된 108명의 피험자를 포함한 세 가지 CD388 임상 시험에서의 안전성 데이터를 요약할 것입니다. 용량, 경로 또는 반복 투여와 관련된 치료에 의해 발생한 이상 반응은 관찰되지 않았으며, 이는 단일 용량으로 계절성 인플루엔자를 예방하기 위한 CD388의 안전성 프로필을 지지합니다.
포스터 발표는 CD388을 피하 주사로 투여받은 27명의 건강한 일본 자원봉사자의 약리학적 및 안전성 데이터에 집중할 것입니다. 결과는 용량 간 낮은-중간 변동성을 보였으며, 이는 서구 참가자를 대상으로 한 이전 연구와 유사했습니다. 임상적으로 중요한 치료에 의해 발생한 이상 반응은 보고되지 않았습니다.
Cidara Therapeutics (Nasdaq: CDTX) a annoncé deux présentations concernant son candidat médicament-Fc conjugué contre la grippe (DFC), CD388, lors de la conférence OPTIONS XII à Brisbane, en Australie. Les présentations mettront en évidence les données de sécurité et de pharmacocinétique provenant d'études cliniques.
La présentation orale résumera les données de sécurité de trois essais cliniques sur CD388 impliquant 108 sujets suivis pendant 5 à 14 mois. Aucun événement indésirable émergent lié à la dose, à la voie d'administration ou au traitement répété n'a été observé, soutenant le profil de sécurité de CD388 pour la prévention de la grippe saisonnière avec une dose unique.
La présentation par affiche se concentrera sur les données de pharmacocinétique et de sécurité de 27 volontaires japonais en bonne santé ayant reçu CD388 par voie sous-cutanée. Les résultats ont montré une variabilité faible à modérée entre les doses et étaient similaires aux études précédentes sur des participants occidentaux. Aucun événement indésirable cliniquement significatif n'a été signalé.
Cidara Therapeutics (Nasdaq: CDTX) gab zwei Präsentationen zu seinem Influenza-Arzneimittel-Fc-Konjugat (DFC)-Kandidaten CD388 auf der OPTIONS XII-Konferenz in Brisbane, Australien, bekannt. Die Präsentationen werden die Sicherheits- und Pharmakokinetikdaten aus klinischen Studien hervorheben.
Die mündliche Präsentation wird die Sicherheitsdaten aus drei klinischen Studien zu CD388 zusammenfassen, an denen 108 Probanden über einen Zeitraum von 5-14 Monaten beteiligt waren. Es wurden keine dosis-, verabreichungsweg- oder wiederholungsbezogenen behandlungsbedingten unerwünschten Ereignisse beobachtet, was das Sicherheitsprofil von CD388 zur Prävention von saisonaler Influenza mit einer Einzeldosis unterstützt.
Die Posterpräsentation wird sich auf Pharmakokinetik- und Sicherheitsdaten von 27 gesunden japanischen Freiwilligen konzentrieren, die CD388 subkutan verabreicht erhielten. Die Ergebnisse zeigten eine geringe bis moderate Variabilität zwischen den Dosen und waren ähnlich zu früheren Studien mit westlichen Teilnehmern. Es wurden keine klinisch signifikanten behandlungsbedingten unerwünschten Ereignisse berichtet.
- CD388 demonstrated a favorable safety profile in clinical trials
- Pharmacokinetic data supports potential use in both immune compromised and immune competent populations
- CD388 shows promise for season-long protection against influenza A and B
- Clinical data supports further studies for single-dose prevention of seasonal influenza
- Pharmacokinetic results in Japanese participants were similar to those in Western participants
- None.
SAN DIEGO, Sept. 25, 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 presentations at OPTIONS XII for the Control of Influenza conference, to be held September 29 through October 2, 2024 in Brisbane, Australia. The presentations, one oral and one poster, will highlight safety and pharmacokinetic (PK) data from clinical studies of CD388, Cidara’s influenza drug-Fc conjugate (DFC) candidate.
“We are pleased to have the opportunity to present at this year’s OPTIONS XII conference and share the clinical data on our universally active influenza preventative, CD388,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “These data support the safety of CD388 administered over a range of doses via multiple routes of administration. Moreover, the pharmacokinetic data support the potential use of CD388 in immune compromised as well as immune competent populations to provide season-long protection against influenza A and B.”
Oral Presentation
Title: Safety Data from Phase 1 and Phase 2a Studies of CD388, a Drug Fc-conjugate for Seasonal Pan-Influenza Prophylaxis
Presenter: Taylor Sandison, MD, MPH, Chief Medical Officer, Cidara Therapeutics
Date/Time: Tuesday, October 1, 2024, 15:51–16:04 AEST
This presentation summarizes the safety data from three CD388 clinical trials that involved 108 subjects who were followed for approximately 5–14 months. There were no dose-, route- or repeat-dose-related treatment-emergent adverse events (TEAEs). Overall, CD388 administered via subcutaneous or intramuscular injection was safe and well-tolerated in all three clinical trials. These data support further clinical studies with CD388 for single-dose prevention of seasonal influenza.
Poster Presentation
Title: Pharmacokinetics and Safety of CD388 Following Subcutaneous Administration in Healthy Japanese Participants
Presenter: Taylor Sandison, MD, MPH, Chief Medical Officer, Cidara Therapeutics
Date/Time: Sunday, September 29, 18:30-20:30 AEST
This presentation summarizes the pharmacokinetics (PK) and safety data of 27 healthy volunteers of Japanese descent dosed subcutaneously with a single dose of CD388 (50, 150, or 450 mg) or placebo. Overall PK parameters showed low-to-moderate variability across all doses and were similar to results from a previous Phase 1 clinical study in Western participants. Safety observations were comparable across the study arms. There were no clinically significant treatment-emergent adverse events (TEAE). These data support further clinical studies with CD388 in the Japanese population for prevention of seasonal influenza.
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 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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LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
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FAQ
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