EDP-323

Therapeutic: EDP-323, in clinical development as a potential treatment for RSV infection

Trial Status: Actively recruiting

Trial Information: This randomized, double-blind, sponsor-open, placebo-controlled study is assessing the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects. Approximately 82 healthy subjects aged 18 to 65 years old will be enrolled. The first phase of the study assesses single ascending doses of EDP-323 or placebo in healthy subjects. A “fasted” and “fed” two-part cohort will also assess food effect. The second phase of the study assesses multiple ascending doses of EDP-323 or placebo for seven days in healthy subjects.

To be included in the study, subjects must have no clinically relevant history of illness or disease. Subjects cannot have infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day 1 visit. Pregnant or nursing females and current tobacco smokers cannot participate.

For more information, visit ClinicalTrials.gov Identifier: NCT05587478

RSVHR

Therapeutic: EDP-938, in clinical development as a potential treatment for RSV infection

Trial Status: Actively recruiting

Trial Information: The Phase 2b, randomized, double-blind, placebo-controlled, multi-center, global study is designed to evaluate the effect of EDP-938 compared with placebo on the progression of RSV infection by assessment of clinical symptoms. Approximately 180 patients will be treated with 800 mg of EDP-938 or placebo for five days and evaluated for 28 days thereafter.

The study will include non-hospitalized adults with up to 72 hours of respiratory tract infection symptoms who test positive for RSV and negative for influenza virus and SARS-CoV-2. To be included in the study, the patient must have at least one of the following conditions that predispose them to complications after RSV infection: age ≥65 years, congestive heart failure (CHF), asthma or chronic obstructive pulmonary disease (COPD). The patient must have a new onset of any of the following symptom(s) or worsening of preexisting symptom(s) consistent with a respiratory tract infection no more than 72 hours prior to the administration of the first dose of study drug: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath. The patient must have at least two of the following symptoms, one of which must be reported as at least ‘moderate’ severity: cough, cough with phlegm, wheezing, or short of breath.

The primary endpoint of the study is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) symptom scale through Day 33. Additional secondary endpoints include additional clinical efficacy measures and antiviral activity compared to placebo, pharmacokinetics, and safety of EDP-938.

For more information, visit ClinicalTrials.gov Identifier: NCT05568706

RSVTx

Therapeutic: EDP-938, in clinical development as a potential treatment for RSV infection

Trial Status: Actively recruiting

Trial Information: RSVTx is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of EDP-938 in adult hematopoietic cell transplant (HCT) recipients with acute RSV infection and symptoms of acute upper respiratory tract infection.

Approximately 200 adult subjects 18 Years to 75 years within 72 hours of symptom onset will be enrolled. Symptoms may include nasopharyngeal discharge, nasopharyngeal congestion, sneezing, sinus congestion, sore throat, hoarseness, earache, cough, shortness of breath, respiratory wheeze, or worsening of one of these symptoms if present chronically. To be included in the study, patients must have received an autologous or allogeneic HCT using any conditioning regimen and have an absolute lymphocyte count (ALC) less than 500 cells/ µL.

The primary objective of the study is theeffect of EDP-938 on development of lower respiratory tract complications in HCT subjects with acute RSV upper respiratory tract infection. The secondary objective of the study is to evaluate viral load and progression to respiratory failure, as well as pharmacokinetics and safety.

For more information, visit ClinicalTrials.gov Identifier: NCT04633187

RSVPEDs

Therapeutic: EDP-938, in clinical development as a potential treatment for RSV infection

Trial Status: Actively recruiting

Trial Information: RSVPEDs is a Phase 2, randomized double-blind, placebo-controlled, dose-ranging study to evaluate EDP-938 in hospitalized or non-hospitalized infants and children aged 28 days to 36 months who test positive for RSV.

Approximately 90 patients aged 28 days to 36 months who test positive for RSV will be enrolled. To be included in the study, patients must have one or more signs of an acute respiratory illness (e.g. fever or symptoms of fever, cough, nasal congestion, runny nose, rapid breathing, shortness of breath, or wheezing) with onset 7 days or less before the time of signing the informed consent form.

The study has two parts, with the primary objective of Part 1 being to evaluate safety and pharmacokinetics. The primary objective of Part 2 is to evaluateantiviral activity as measured by the change in RSV shedding in nasopharyngeal swab samples determined using quantitative RT-PCR.

To visit the clinical trial website for RSVPEDs, click here

For more information, visit ClinicalTrials.gov Identifier: NCT04816721