CD388 / Cidara Therap - LARVOL DELTA

Merck to buy Cidara Therapeutics for $9.2 billion as Keytruda patent cliff approaches (iNVEZZ) - "Merck & Co. has agreed to acquire biotechnology firm Cidara Therapeutics in a $9.2 billion deal, accelerating efforts to broaden its respiratory portfolio as it prepares for the loss of exclusivity on its blockbuster cancer drug Keytruda later this decade...At the centre of the acquisition is Cidara’s lead programme, CD388, a long-acting antiviral agent now in Phase 3 trials. The treatment is being tested as a preventive therapy for influenza in people at high risk of severe illness."

M&A • Infectious Disease

NAVIGATE-2: A Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies Following Annual Doses of CD388 (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Cidara Therapeutics Inc.

New P2 trial

ANCHOR: A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza (clinicaltrials.gov) - P3 | N=6000 | Recruiting | Sponsor: Cidara Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

NAVIGATE: Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications (clinicaltrials.gov) - P2 | N=5071 | Completed | Sponsor: Cidara Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Cidara Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for CD388 in Seasonal Influenza Prevention (GlobeNewswire) - "The Breakthrough Therapy designation is based on positive results from the Phase 2b NAVIGATE trial in which CD388 provided statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64."

Breakthrough therapy • Influenza

Prophylactic Efficacy of CD388, a Novel Drug-Fc Conjugate, in a Human Influenza A/H3N2 Virus Challenge Model: A Randomized, Controlled Phase 2a Study. (PubMed, Clin Infect Dis) - P2 | "CD388 was well-tolerated and demonstrated prophylactic activity against RT-qPCR-confirmed influenza infection in a human challenge study. The efficacy of CD388 in preventing influenza will be confirmed in larger studies. Clinical Trials Registration.  ClinicalTrials.gov identifier: NCT05523089."

Clinical • Journal • P2a data • Infectious Disease • Influenza • Respiratory Diseases

ANCHOR: A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza (clinicaltrials.gov) - P3 | N=5500 | Not yet recruiting | Sponsor: Cidara Therapeutics Inc.

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Absorption, distribution, metabolism, and excretion of an antiviral drug-Fc conjugate CD388 following subcutaneous administration of 14C-CD388 in the rat. (PubMed, Drug Metab Dispos) - "Catabolism of the Fc domain resulted in formation of metabolites containing the unmodified dimeric zanamivir plus linker. These data support the mode of action of CD388 and demonstrate that the conjugation of zanamivir to the Fc domain is stable, thereby enabling CD388 to maintain its potent antiviral activity."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Drug-Fc conjugate CD388 targets influenza virus neuraminidase and is broadly protective in mice. (PubMed, Nat Microbiol) - "CD388 improves the antiviral activity of zanamivir, demonstrating potent, universal activity across influenza A and B viruses, including high pathogenicity and neuraminidase inhibitor resistant strains, a low potential for resistance development and potent efficacy in lethal mouse infection models. These results suggest that CD388 has the potential for universal prevention of influenza A and B in healthy and high-risk populations."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Cidara Therapeutics Announces Two Presentations on CD388 in Influenza at International Conference on Antiviral Research (ICAR) 2025 (GlobeNewswire) - "Cidara Therapeutics, Inc...today announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR). The conference takes place from March 17-21, 2025 in Las Vegas, Nevada. Cidara’s presentations will highlight the study design, demographic information, and preliminary safety data from the ongoing Phase 2b NAVIGATE trial of CD388, as well as dose optimization models for evaluation of CD388 in a Phase 3 study."

Clinical • Clinical protocol • P2b data • Influenza

Cidara Therapeutics Announces Publication of CD388 Preclinical Data in Nature Microbiology (GlobeNewswire) - "The publication describes CD388 and its potential for universal activity across influenza A and B viruses in cellular and animal models. Administration of CD388 resulted in the following: Potent, universal activity against all influenza A and B virus strains, including high pathogenicity strains like H5N1, also known as avian influenza or bird flu, and strains that are resistant to approved neuraminidase inhibitors; Low potential for resistance development; Efficacy at similar exposures in immune-competent and immune-compromised lethal challenge models in mice demonstrating that efficacy is driven predominantly by the intrinsic antiviral activity of CD388."

Preclinical • Infectious Disease • Influenza

NAVIGATE: Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications (clinicaltrials.gov) - P2 | N=5000 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

NAVIGATE: Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications (clinicaltrials.gov) - P2 | N=5000 | Recruiting | Sponsor: Cidara Therapeutics Inc. | Trial completion date: May 2025 ➔ Sep 2025 | Trial primary completion date: May 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

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 (IDWeek 2024) - No abstract available

Clinical • PK/PD data • Infectious Disease • Influenza

CD388, a Novel Drug-Fc Conjugate (DFC), Demonstrates Prophylactic Activity in an Influenza Human Challenge Model (IDWeek 2024) - No abstract available

Infectious Disease • Influenza

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 (IDWeek 2024) - No abstract available

Clinical • PK/PD data • Infectious Disease • Influenza

NAVIGATE: Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications (clinicaltrials.gov) - P2 | N=5000 | Recruiting | Sponsor: Cidara Therapeutics Inc.

New P2 trial • Infectious Disease • Influenza • Respiratory Diseases

Cidara Therapeutics Restructures Workforce to Focus on Planned Clinical Development of CD388 (GlobeNewswire) - "Cidara Therapeutics...announced a reduction in its workforce to focus on the clinical development of CD388, the Company’s novel DFC candidate for influenza A and B. The planned reduction impacts approximately 30% of the Cidara workforce....These strategic initiatives are expected to substantially reduce capital needs and allow Cidara to focus on its planned Phase 2b and potential subsequent trials investigating CD388 as a single-dose, universal preventative for influenza A and B. The Company continues business development discussions for its oncology DFC programs, including CBO421, a CD73 inhibitor..."

Pipeline update • Infectious Disease • Influenza • Oncology • Solid Tumor

The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults (clinicaltrials.gov) - P2 | N=59 | Completed | Sponsor: Cidara Therapeutics Inc. | Phase classification: P2a ➔ P2

Phase classification • Infectious Disease • Influenza • Respiratory Diseases

Cidara Therapeutics to Present Preclinical Data on CD388 at ASM Microbe 2024 Conference (GlobeNewswire) - "Cidara Therapeutics, Inc....today announced the company will be presenting a poster at the American Society for Microbiology (ASM) Microbe 2024 conference to be held June 13-17, 2024 at the Georgia World Congress Center in Atlanta, Georgia."

Preclinical • Influenza

Comparison of Different Allometric Scaling Approaches to Project Human Pharmacokinetics (PK) of CD388, a Novel Drug-Fc Conjugate, in Development for Influenza Prevention (ASM Microbe 2024) - "Allometric scaling using exponents typical of small molecule therapeutics provided a better prediction of human CD388 PK that are necessary to consider evaluation in a FIH study."

PK/PD data • Infectious Disease • Influenza • Respiratory Diseases

Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: Cidara Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion

Single Ascending Dose Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza (IDWeek 2023) - No abstract available

Clinical • PK/PD data • Infectious Disease • Influenza

Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), is Driven by the Small Molecule Neuraminidase Inhibitor (NAI) (IDWeek 2023) - No abstract available

Clinical • Infectious Disease

In Vivo Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), Against Seasonal Subtypes of Influenza in Prophylaxis in Immune Competent Mice, and in a Severe Immunodeficient (SCID) Mouse Model (IDWeek 2023) - No abstract available

Preclinical • Infectious Disease • Influenza