Enanta Pharmaceuticals Announces First Patient Dosed in the RESOLVE Phase 2b/3 Study of Zelicapavir, a Potential First-in-Disease Treatment for Respiratory Syncytial Virus (RSV)
Key Highlights
- ➤RESOLVE Phase 2b/3 trial dosed its first patient in high-risk adult RSV outpatients
- ➤Topline Phase 2b data expected in 2027
- ➤Phase 2b will enroll at least 200 patients; Phase 3 approximately 660
- ➤Prior HR3 trial showed 6.7-day symptom-resolution benefit for zelicapavir
- ➤Prior trial RSV-related hospitalizations were 0% zelicapavir versus 5% placebo
Expert Statements
Scott T. Rottinghaus, Chief Medical Officer of Enanta Pharmaceuticals
“We are excited to advance our zelicapavir program into a Phase 2b/3 study with the dosing of the first patient in RESOLVE”
Scott T. Rottinghaus, Chief Medical Officer of Enanta Pharmaceuticals
“Based on learnings from our Phase 2 RSVHR study, the RESOLVE trial is enrolling adults at high risk for severe outcomes from RSV.”
Scott T. Rottinghaus, Chief Medical Officer of Enanta Pharmaceuticals
“These patients with congestive heart failure, chronic obstructive pulmonary disease, or age of 75 or older have substantial disease burden and the potential to benefit from an RSV treatment.”
Scott T. Rottinghaus, Chief Medical Officer of Enanta Pharmaceuticals
“The Phase 2b portion is designed to confirm the treatment effect size and generate an additional dataset with the goal of strengthening the clinical evidence supporting zelicapavir.”
Scott T. Rottinghaus, Chief Medical Officer of Enanta Pharmaceuticals
“Together with LOTUS, our pediatric Phase 2b trial, this progress positions us to deliver two important Phase 2b data readouts in 2027 and marks a significant step forward in the development of zelicapavir.”
Scott T. Rottinghaus, Chief Medical Officer of Enanta Pharmaceuticals
“With no approved RSV antiviral therapies currently available, these advancements underscore the potential for zelicapavir to become a first-in-disease antiviral treatment.”
Juan Antonio Carmona Herrera, Principal Investigator in the RESOLVE study and President of C&A Clinical Trials Corp.
“RSV remains a significant cause of illness, particularly among older adults and individuals with underlying health conditions who are at heightened risk of severe disease. Despite RSV’s burden, there are no treatment options available”
Juan Antonio Carmona Herrera, Principal Investigator in the RESOLVE study and President of C&A Clinical Trials Corp.
“An effective antiviral has the potential to change the way RSV is managed by directly targeting the virus, with the goal of reducing disease severity, preventing complications, and improving patient outcomes.”
Juan Antonio Carmona Herrera, Principal Investigator in the RESOLVE study and President of C&A Clinical Trials Corp.
“The development of a treatment specifically for RSV would represent an important advancement for physicians and the millions of patients at risk of serious illness each year.”
Enanta Pharmaceuticals Announces First Patient Dosed in the RESOLVE Phase 2b/3 Study of Zelicapavir, a Potential First-in-Disease Treatment for Respiratory Syncytial Virus (RSV)
* Global Phase 2b/3 Study Will Evaluate Symptom Duration and Hospitalization Rates in Adult Outpatients at High Risk of Severe Outcomes from RSV
Get started
Create a free account to read the full story.