CD388 for Flu Prevention

(ANCHOR Trial)

Recruiting at 149 trial locations

Overseen By Head of Clinical Operations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Cidara Therapeutics Inc.

Must not be taking: Zanamivir, Monoclonal antibodies

Disqualifiers: Pregnancy, Influenza, Severe CKD, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial aims to test the effectiveness of the new treatment, CD388, in preventing the flu compared to a placebo. Participants will receive CD388 through subcutaneous injections (a shot under the skin), and the study will assess the treatment's safety and tolerability. Suitable candidates for this trial include individuals with conditions such as moderate to severe asthma, chronic lung disease, heart disease, insulin-dependent diabetes, or moderate kidney issues, who have experienced frequent flu complications in the past. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking flu prevention treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain drugs or biologic agents for influenza prevention or treatment within a specific timeframe before the study. It's best to discuss your current medications with the study team to ensure they don't conflict with the trial requirements.

Is there any evidence suggesting that CD388 is likely to be safe for humans?

Research has shown that CD388 is safe for use. In a study where participants were exposed to the flu, CD388 proved to be safe and well-tolerated, with no major side effects reported. This finding suggests that CD388 could be a safe option for preventing the flu, even for those at higher risk of complications. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CD388 for flu prevention because it offers a new way to tackle the virus compared to traditional vaccines and antiviral medications like oseltamivir. Unlike most flu treatments that target the virus after infection, CD388 is designed to prevent the flu by blocking the virus from entering cells in the first place. This means it could potentially offer broader and longer-lasting protection. Additionally, CD388 is administered through a simple subcutaneous injection, which could make it more convenient for people who prefer not to receive traditional vaccines.

What evidence suggests that CD388 might be an effective treatment for flu prevention?

Studies have shown that CD388, which participants in this trial may receive, can effectively prevent the flu. In earlier research, one dose of CD388 provided 76% protection against the flu for 24 weeks, outperforming a placebo. The level of protection varied with different doses, with lower doses offering slightly less protection. Overall, CD388 has shown promise as a strong defense against flu infections, surpassing some vaccines. ^{3 5 6 7 8}

Who Is on the Research Team?

Nicole Davarpanah, MD, JD

Principal Investigator

Cidara Therapeutics Inc.

Are You a Good Fit for This Trial?

This trial is for adults and adolescents at high risk of flu complications. Participants will receive a single dose of CD388 or placebo through three subcutaneous injections to see if it prevents symptomatic, lab-confirmed influenza.

Inclusion Criteria

Written informed consent and any locally required authorization obtained from the participant before performing any protocol-related procedures

Has negative rapid antigen tests for influenza and SARS-CoV-2 prior to dosing at Day 1

BMI is ≥ 18 kg/m^2 at screening

Exclusion Criteria

Had close contact with individuals with confirmed influenza or SARS-CoV-2

Known or suspected allergy or history of serious adverse reactions to specified medications

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of CD388 or placebo via 3 subcutaneous injections

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

3 visits (in-person) on Day 8, Day 29, and Day 197

What Are the Treatments Tested in This Trial?

Interventions

• CD388

Trial Overview The study tests the effectiveness of CD388 in preventing the flu compared to a placebo. It involves one-time administration via subcutaneous injections and monitors participants for signs of influenza infection.

How Is the Trial Designed?

Group I: CD388 Experimental Treatment 1 Intervention

Participants are randomized to receive 450 milligrams (mg) CD388 by SQ injection. Participants are randomized at a 1:1 ratio between the 2 arms.

Group II: Placebo Placebo Group 1 Intervention

Participants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1 ratio between the 2 arms.

Who Is Running the Clinical Trial?

Cidara Therapeutics Inc.

Lead Sponsor

Trials

12

Recruited

7,400+

Citations

1. cidara.com cidara.com/news/cidara-therapeutics-announces-positive-topline-results-from-its-phase-2b-navigate-trial-evaluating-cd388-a-non-vaccine-preventative-of-seasonal-influenza/

Cidara Therapeutics Announces Positive Topline Results ... Single doses of 450mg, 300mg and 150mg of CD388 conferred 76%, 61% and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05523089

The Effectiveness of CD388 to Prevent Flu in an Influenza ... The purpose of this study is to evaluate the preventative antiviral activity of CD388, as compared to saline placebo, when administered as a single dose to ...

3. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf465/8276183

Prophylactic Efficacy of CD388, a Novel Drug–Fc Conjugate ... Conclusions. CD388 was well-tolerated and demonstrated prophylactic activity against RT-qPCR–confirmed influenza infection in a human challenge ...

4. vaccineadvisor.com vaccineadvisor.com/news/novel-antiviral-gets-breakthrough-tx-status-for-universal-flu-protection/

Novel Antiviral Gets Breakthrough Tx Status for Universal ... Over 24 weeks, statistically significant prevention efficacy (PE) was observed for all 3 doses of CD388 compared with placebo (PE: 150mg: 57.7% ...

5. cidrap.umn.edu cidrap.umn.edu/influenza-general/experimental-flu-drug-may-protect-better-flu-vaccines-company-data-show

Experimental flu drug may protect better than flu vaccines, ... Single doses of 150 milligrams (mg), 300 mg, and 450 mg provided 58%, 61%, and 76% protection from symptomatic flu, respectively, for about 6 ...

6. cidara.com cidara.com/news/cidara-therapeutics-receives-u-s-fda-breakthrough-therapy-designation-for-cd388-in-seasonal-influenza-prevention/

Cidara Therapeutics Receives U.S. FDA Breakthrough ... As a long-acting prophylactic drug, CD388's activity does not rely on an immune response, making it a potential prevention option for high-risk ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07159763

A Study to Evaluate the Safety and Efficacy of CD388 ... The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo ...

8. nature.com nature.com/articles/s41564-025-01955-3

Drug–Fc conjugate CD388 targets influenza virus ... CD388 improves the antiviral activity of zanamivir, demonstrating potent, universal activity across influenza A and B viruses.