Cidara Therapeutics, Inc. (CDTX), a biotechnology company, on Friday announced that the first participants have been dosed in its Phase 3 trial to evaluate the safety and efficacy of its drug candidate CD388 in populations at high risk for complications of influenza.
Cidara is proceeding with an expanded and accelerated development plan seeking a biologics license application (BLA) approval based on a single Phase 3 study of CD388 to treat influenza.
Influenza is a contagious viral infection that can cause mild to severe illness, sometimes resulting in death. In the US alone, the firm estimates 0.6 million to 1.3 million cases of influenza hospitalisation and 26,000 to 0.13 million influenza deaths.
CD388, a flu drug-Fc conjugate candidate of Cidara, combines zanamivir, the active ingredient of FDA-approved influenza drug Relenza, with a clinically validated human antibody fragment. It is not a vaccine, but a long-acting antiviral drug.
A drug-Fc conjugate (DFC) is a therapeutic molecule that links a drug, such as a small molecule or peptide, to a fragment of a human antibody to prolong its half-life and enhance its effectiveness.
The Phase 3 trial, named ANCHOR, is a global, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of CD388 administered as a one-time 450-milligram subcutaneous dose in adults and adolescents.
Based on the recent FDA's feedback, the study population has been expanded to also include generally healthy adults over 65 years old with no specific comorbidities, which is the simultaneous presence of two or more conditions. This is in addition to other high-risk populations with certain comorbidities and an immunocompromised status.
Earlier this Wednesday, the company reported intending to begin enrollment by the end of September 2025 in the Northern Hemisphere, with continuation into the spring of 2026 in the Southern Hemisphere, with a target enrollment of 6,000 subjects.
The study also includes an interim analysis following the Northern Hemisphere flu season to assess the trial size and powering assumptions and determine enrollment for the Southern Hemisphere flu season.
The primary endpoint of the trial will be based on laboratory-confirmed influenza, body temperature 37.2°C or 99°F, and new or worsening of either two respiratory symptoms like cough, sore throat, nasal congestion, or one respiratory symptom and one new systemic symptom like headache, fatigue, feeling feverish, or body aches.
In June, Cidara announced the positive top-line results from its Phase 2b NAVIGATE trial of CD388. In addition, CD388 was granted Fast Track Designation by the FDA in June 2023.
"As CD388 is not a vaccine, its activity does not rely on an immune response and has the potential to be an effective season-long flu preventative for those at risk from complications from influenza, those who do not respond to vaccines, or those who prefer not to receive a vaccine. We look forward to enrolling the Phase 3 study, beginning today with the 2025 Northern Hemisphere influenza season." Said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
CDTX has traded in a range of $10.14 to $90.64 in the last 1 year. The stock closed yesterday's trading at $84.76, down 4.31%.
For comments and feedback contact: editorial@rttnews.com
Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.