EDP-938 for Children with RSV

(RSVPEDs Trial)

No longer recruiting at 92 trial locations

Overseen By Enanta Pharmaceuticals, Inc

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Enanta Pharmaceuticals

Must not be taking: Immunosuppressants, Ribavirin, Palivizumab, others

Disqualifiers: Immune deficiency, Transplant, Chronic oxygen, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called EDP-938, an experimental drug for children with RSV, a virus affecting the lungs and breathing passages. Researchers aim to determine if EDP-938 is safe and effective for treating RSV infections by comparing it to a placebo, which contains no active medicine. Children diagnosed with RSV and showing symptoms of a recent respiratory illness might be suitable candidates. The goal is to find a better way to help young children recover from RSV infections. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that certain RSV treatments must not have been taken recently. It's best to discuss your specific medications with the trial team.

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

Research has shown that EDP-938 has been safe in earlier studies. In one study where participants received EDP-938 for a short time, they tolerated it well, and no major safety issues emerged. This suggests that the treatment is generally safe in the situations studied so far.

While these results are encouraging, ongoing trials continue to gather more information, especially in children with RSV. Prospective participants should consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about EDP-938 for treating RSV (Respiratory Syncytial Virus) in children because it offers a novel approach compared to existing treatments. Current options mainly focus on symptom relief or preventing severe cases with monoclonal antibodies. EDP-938 stands out by directly inhibiting the RSV virus, potentially stopping it in its tracks. This oral medication could also provide a more convenient and faster-acting solution, offering relief in just five days.

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, could effectively treat RSV, a virus affecting the lungs. In one study where participants were exposed to RSV, EDP-938 significantly reduced the virus levels in their bodies. This drug blocks a protein that RSV needs to spread. Although one study did not achieve its main goal, positive results emerged in other areas and specific groups. Overall, EDP-938 has demonstrated a strong ability to combat the virus and is less likely to become ineffective over time, suggesting it could be a promising option for treating RSV. ^{1 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?

This trial is for children with RSV infection. It includes kids aged 6 months to less than 3 years, and infants from about a month old to under 6 months who were born after at least 29 weeks of pregnancy. Caregivers must understand the study's needs and ensure the child can complete it. Children on certain life support, with recent transplants or cancer treatments, chronic oxygen therapy, immune deficiencies, or recent RSV medications are excluded.

Inclusion Criteria

I am a child aged between 28 days and 36 months, and if under 6 months, I was born after 29 weeks of gestation.

I have been diagnosed with an RSV infection.

In the Investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

Exclusion Criteria

I do not need life support treatments and am expected to survive my current illness.

I have not had, nor am I waiting for, any transplant or received chemotherapy or radiation in the last year.

I use oxygen at home regularly before being admitted.

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 for 5 days

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EDP-938

Trial Overview The study tests EDP-938 against a placebo in two parts to check its safety and effectiveness in treating RSV in children. The first part will focus on how well the drug works and if it's safe; the second part will look into how much of the drug gets into the bloodstream and how long it stays there.

How Is the Trial Designed?

Group I: EDP-938 Experimental Treatment 1 Intervention

EDP-938, oral suspension, once daily for 5 days

Group II: Placebo Placebo Group 1 Intervention

Matching placebo, orally, once daily for 5 days

Who Is Running the Clinical Trial?

Enanta Pharmaceuticals

Lead Sponsor

Trials

34

Recruited

2,400+

Enanta Pharmaceuticals, Inc

Lead Sponsor

Trials

42

Recruited

3,200+

Published Research Related to This Trial

In a phase 2a trial involving 178 participants, EDP-938 significantly reduced RSV viral load and total symptom scores compared to placebo, indicating its efficacy as a treatment for RSV infection.

All dosing regimens of EDP-938 demonstrated a safety profile similar to placebo, suggesting that it is a safe option for treating RSV without major side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge. Ahmad, A., Eze, K., Noulin, N., et al.[2023]

EDP-938, a second-generation antiviral drug for respiratory syncytial virus (RSV), has shown high efficacy in reducing viral load in the lower respiratory tract during early human trials.

The drug is rapidly absorbed after oral administration, with a half-life of 11-18 hours, and administration of up to 600 mg/day for seven days resulted in minimal significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[EDP-938, a new antiviral with inhibitory activity against the nucleoprotein of the respiratory syncytial virus]. Reina, J., Iglesias, C.[2023]

EDP-938 is a promising new antiviral drug that effectively inhibits respiratory syncytial virus (RSV) replication, showing strong activity against various RSV strains with low effective concentrations (EC50s) in human bronchial epithelial cells.

It works by targeting a specific step in the viral life cycle and has a higher barrier to resistance compared to other antiviral drugs, making it a potentially robust treatment option, as demonstrated by its efficacy in a non-human primate model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EDP-938, a novel nucleoprotein inhibitor of respiratory syncytial virus, demonstrates potent antiviral activities in vitro and in a non-human primate model. Rhodin, MHJ., McAllister, NV., Castillo, J., et al.[2021]

Citations

1. ir.enanta.com ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-presents-new-data-zelicapavir-its-n

Press Release Details ... Respiratory Syncytial Virus (RSV) at IDWeek™ 2025. Oct 20, 2025. PDF ... These data suggest that EDP-323 is highly effective in preventing RSV ...

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/2022/12/SLIDES-EDP-938-Challenge-TOPLINE-DATA-FINAL.pdf

EDP 938-101 Phase 2a Study: Human Challenge Study This presentation contains forward-looking statements concerning our RSV program, as well as our plans, objectives and.

4. 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 ...

5. fiercebiotech.com fiercebiotech.com/biotech/enanta-sees-rsv-drug-fail-phase-2b-finds-positives-secondaries-and-subgroups

Enanta sees RSV drug fail phase 2b but finds positives A phase 2b trial of Enanta Pharmaceuticals' respiratory syncytial virus (RSV) drug candidate has missed its primary endpoint.

6. medchemexpress.com medchemexpress.com/zelicapavir.html?srsltid=AfmBOoqBvcEZsZTwdD0ZrBpgxFWU1YNwyc41A4_CooQ345Plhknkx4pj

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 ...

7. adisinsight.springer.com adisinsight.springer.com/drugs/800047319

Zelicapavir - Enanta Pharmaceuticals - AdisInsight - Springer Zelicapavir also known as EDP 938 is an oral, small molecule, non-fusion N-protein inhibitor of both RSV-A and RSV-B activity, being developed by Enanta.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05568706

A Study of EDP-938 in Non-hospitalized Adults With RSV ... This is a Phase 2b, randomized, double-blind, placebo-controlled study of EDP-938 administered orally for the treatment of non-hospitalized adult subjects ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33720995/

EDP-938, a novel nucleoprotein inhibitor of respiratory ... EDP-938 is a novel non-fusion replication inhibitor of respiratory syncytial virus (RSV). It is highly active against all RSV-A and B laboratory strains and ...