EDP-323 / Enanta Pharma - LARVOL DELTA

Post-Exposure Prophylaxis (PEP) of Respiratory Syncytial Virus (RSV) Infection After High-Inoculum RSV Human Challenge: Analysis of a Randomized Double-Blind, Placebo-Controlled Trial of EDP-323, an Oral, Non-Nucleoside Polymerase Inhibitor Antiviral (IDWeek 2025) - No abstract available

Clinical • Infectious Disease • Respiratory Syncytial Virus Infections

EDP-323, a First-in-Class, Oral, RSV-Specific, Non-Nucleoside L-Protein Inhibitor Antiviral Rapidly Reduces Total RSV Symptoms, Lower Respiratory Tract RSV Symptoms and Viral Load After Human Viral Challenge (IDWeek 2025) - No abstract available

Infectious Disease

A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Enanta Pharmaceuticals, Inc | Recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323. (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Enanta Pharmaceuticals, Inc | Recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

EDP-323, a First-In-Class, Once-Daily, Oral L-Protein Inhibitor for the Treatment of RSV: Results From a Phase 1 Study in Healthy Adults. (PubMed, Clin Transl Sci) - "The half-life of EDP-323 (t1/2 = 10.8-16.6 h) supported once-daily dosing, and no food effect was observed. EDP-323 demonstrated a favorable safety and PK profile, supporting its potential as a once-daily oral treatment for RSV."

Clinical • Journal • P1 data • Infectious Disease • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Enanta Pharmaceuticals, Inc

New P1 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

EDP-323, a first-in-class, oral, RSV L-protein inhibitor reduces disease severity (respiratory mucus production) and accelerates viral clearance in a human viral challenge study (ESCMID Global 2025) - No abstract available

Respiratory Syncytial Virus Infections

Enanta Pharmaceuticals to Present Data for its Respiratory Syncytial Virus Program at the 13th International RSV Symposium (Businesswire) - "Enanta Pharmaceuticals, Inc...today announced that an oral presentation and three posters, including one late breaker, highlighting the company’s respiratory syncytial virus (RSV) program, will be presented at the 13th International RSV Symposium (RSV 2025) being held March 12-15 at Bourbon Cataratas do Iguazu, in Iguazu Falls, Brazil. Results from a Phase 2 human challenge study of EDP-323, an RSV L-protein inhibitor...will be highlighted in an oral presentation. Data from a Phase 2 study of zelicapavir, an N-protein inhibitor, for the treatment of RSV in young children will be presented in a late breaker poster. An additional poster will highlight distinctions among fusion, N, and L inhibitors with respect to preclinical antiviral effect and resistance profiles, while a third poster will detail PK and PK/PD results from the EDP-323 Phase 2 human challenge study."

Clinical data • Preclinical • Infectious Disease • Respiratory Syncytial Virus Infections

A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323. (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Enanta Pharmaceuticals, Inc

New P1 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model (clinicaltrials.gov) - P2 | N=142 | Completed | Sponsor: Enanta Pharmaceuticals, Inc | Recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model (clinicaltrials.gov) - P2 | N=114 | Recruiting | Sponsor: Enanta Pharmaceuticals, Inc

New P2 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

EDP-323, a First-in-Class, Once-Daily, Oral L-Protein Inhibitor for the Treatment of RSV: Results from a Phase 1 Study in Healthy Subjects and Correlation with In Vitro Antiviral Activity (ESWI 2023) - No abstract available

P1 data • Preclinical

A Study of EDP-323 in Healthy Subjects (clinicaltrials.gov) - P1 | N=82 | Completed | Sponsor: Enanta Pharmaceuticals, Inc | Recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-323, its Oral, L-Protein Inhibitor in Development for the Treatment of Respiratory Syncytial Virus (Businesswire) - "Enanta Pharmaceuticals, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV)....Enanta plans to present new preclinical PK data at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April and expects to report topline data from the Phase 1 study this quarter."

Fast track designation • P1 data • Preclinical • Infectious Disease • Respiratory Syncytial Virus Infections

Pharmacokinetics of EDP-323, a potent, once-daily, oral antiviral treatment for respiratory syncytial virus (ECCMID 2023) - No abstract available

PK/PD data • Respiratory Diseases

A Study of EDP-323 in Healthy Subjects (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: Enanta Pharmaceuticals, Inc

New P1 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections