EDP-938 for Respiratory Syncytial Virus

(RSVHR Trial)

No longer recruiting at 98 trial locations

Overseen By Enanta Pharmaceuticals, Inc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Enanta Pharmaceuticals, Inc

Must not be taking: Antivirals, Antibacterials

Disqualifiers: COPD, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called EDP-938 (also known as Zelicapavir or EP 023938) for individuals with confirmed RSV (Respiratory Syncytial Virus) infections who are not hospitalized but are at high risk for complications. The goal is to determine if EDP-938 can improve symptoms such as cough, wheezing, or shortness of breath. Participants will receive either the actual treatment or a placebo (a pill with no active medicine). This trial suits adults with asthma, COPD, or heart failure who have recently experienced symptoms like fever, fatigue, or a cough and have tested positive for RSV. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken certain antiviral, antibacterial, antifungal, or antimycobacterial medications within 7 days before joining. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that EDP-938 is likely to be safe for humans?

Research has shown that EDP-938 has been safe in past studies, meaning most participants did not experience serious side effects. In a previous study, EDP-938 was tested on people and found to be safe, with no major safety issues reported. This suggests that EDP-938 is generally safe for humans, but individual reactions can vary. As this treatment is still under investigation, more information will be collected to ensure its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for RSV?

Unlike the standard of care for Respiratory Syncytial Virus (RSV), which typically includes supportive care and the use of antiviral drugs like ribavirin, EDP-938 works differently by targeting the virus's replication process. Researchers are excited about EDP-938 because it inhibits a vital protein in RSV, potentially stopping the virus from spreading in the body more effectively than current options. This unique mechanism of action could lead to quicker symptom relief and better outcomes for patients battling RSV.

What evidence suggests that EDP-938 might be an effective treatment for RSV?

Research has shown that EDP-938, which participants in this trial may receive, holds promise for treating respiratory syncytial virus (RSV). In a previous study, it helped people with chronic obstructive pulmonary disease (COPD) recover from RSV symptoms about 6.7 days faster. EDP-938 stops the virus from replicating. Another study found that EDP-938 significantly reduced the amount of virus in the body. It has also been effective against different types of RSV. This evidence suggests that EDP-938 could be a good treatment option for RSV infections. ^{5 6 7 8 9}

Who Is on the Research Team?

Enanta Pharmaceuticals, Inc

Principal Investigator

Enanta Pharmaceuticals, Inc

Are You a Good Fit for This Trial?

Adults over 65 or those with heart failure, asthma, COPD at high risk for RSV complications can join. They must have recent respiratory symptoms and a positive RSV test. Participants need to use contraception if of childbearing potential. Exclusions include recent COVID-19 infection, severe lung function impairment, certain heart conditions, living in care facilities receiving acute respiratory management, imminent hospitalization need, recent systemic anti-infective therapy or active viral hepatitis/HIV.

Inclusion Criteria

I am 65 or older, or have CHF, asthma, or COPD.

Subject has tested positive for RSV infection using a NAAT (polymerase chain reaction [PCR] or other) on a nasal/nasopharyngeal swab sample

A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug

Exclusion Criteria

I have had a lung infection, other than RSV, within the last week.

Subject has a known positive human immunodeficiency virus infection, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled

I have not taken any antiviral, antibacterial, antifungal, or antimycobacterial medication in the last 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EDP-938 or placebo orally once daily

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EDP-938
• Placebo

Trial Overview The trial is testing EDP-938 against a placebo in non-hospitalized adults with confirmed RSV who are at high risk for complications. It's a Phase 2b study where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting (double-blind).

How Is the Trial Designed?

Group I: EDP-938 Experimental Treatment 1 Intervention

EDP-938 800 mg, once daily

Group II: Placebo Placebo Group 1 Intervention

Matching placebo, once daily

Who Is Running the Clinical Trial?

Enanta Pharmaceuticals, Inc

Lead Sponsor

Trials

42

Recruited

3,200+

Citations

1. ir.enanta.com ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-positive-topline-results-its

Press Release Details - Investors - Enanta Pharmaceuticals 6.7-Day Improvement in Time to Complete Resolution of All RSV Symptoms for Patients with Chronic Obstructive Pulmonary Disease (COPD), ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39441691/

EDP-938 Has a High Barrier to Resistance in Healthy ... EDP-938 is an oral once-daily RSV nucleoprotein (N) inhibitor with potent antiviral activity. In a human RSV challenge trial, EDP-938 significantly reduced ...

3. enanta.com enanta.com/wp-content/uploads/2022/11/EP-023938-Poster-for-RSV16-Conference.pdf

EP-023938, A Novel Non-Fusion Replication Inhibitor of ... EP-023938 is a potent inhibitor of both RSV-A and RSV-B, maintaining antiviral potency across all clinical isolates tested.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04196101

A Study to Assess EDP-938 for the Treatment of Acute ... This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP ...

5. synapse.patsnap.com synapse.patsnap.com/drug/b267e15d133843a68459ac8dac00554c

Zelicapavir - Drug Targets, Indications, Patents In a human RSV challenge trial, EDP-938 significantly reduced viral load ... The absence of an effective vaccine against respiratory syncytial virus (RSV) ...

6. enanta.com enanta.com/wp-content/uploads/2022/12/SLIDES-EDP-938-Challenge-TOPLINE-DATA-FINAL.pdf

EDP 938-101 Phase 2a Study: Human Challenge Study • EDP-938 demonstrated a favorable safety profile over 5 ... Discovery of EP-023938, a Novel Non-Fusion Inhibitor of Respiratory Syncytial Virus.

7. enanta.com enanta.com/pipeline/respiratory-syncytial-virus/

Respiratory Syncytial Virus Enanta's most advanced candidate for RSV is zelicapavir (EDP-938) ... The study also showed that zelicapavir demonstrated a favorable safety profile and was well- ...

8. medchemexpress.com medchemexpress.com/zelicapavir.html?srsltid=AfmBOoqWswi7WVXe_UQeyXQ71u3_KUNGSY5Bult--YJOLL-qi_pJ7QcA

Zelicapavir (EDP-938) | RSV Inhibitor Zelicapavir inhibits RSV strains RSV-A Long, RSV-A2, RSV-A M37, RSV-B VR-955 in cells Hep-2, A549, Vero, HBEC, reduces the level of viral RNA in ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04196101

NCT04196101 | A Study to Assess EDP-938 for the ... This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP ...