EDP-938 for Children with RSV

(RSVPEDs Trial)

Recruiting at 78 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

96 Participants Needed

Trial Summary

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.

How is the drug EDP-938 different from other treatments for RSV?

EDP-938 is unique because it targets the nucleoprotein of the RSV virus, blocking its replication after the virus has entered the cell, unlike older treatments that prevent the virus from entering the cell. This drug is taken orally and has shown high efficacy with a low risk of resistance, making it a promising option for treating RSV. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new medicine called EDP-938 in young children with RSV. The goal is to see if EDP-938 can safely help these children by stopping the virus from multiplying and causing illness. EDP-938 has shown strong antiviral activities in laboratory and animal studies.

Research Team

Enanta Pharmaceuticals, Inc

Principal Investigator

Enanta Pharmaceuticals, Inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2021]

2. Denmark pubmed.ncbi.nlm.nih.gov

RSV prevention and treatment in pediatric lung transplant patients: a survey of current practices among the International Pediatric Lung Transplant Collaborative. [2015]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of the 2014 American Academy of Pediatrics Policy on RSV Hospitalization in Preterm Infants in the United States. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge. [2023]