Slide 1: Zelicapavir Decreases Symptom Duration, Hospitalization, and Viral Load in High-Risk Adults with RSV
Zelicapavir Decreases Symptom Duration, Hospitalization, and Viral Load in a Global, Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of High-Risk Adults with RSV C. Harris, J. DeVincenzo, S. Chen, T. Ngo, A. Ahmad, M. Turnak, S. Rottinghaus Enanta Pharmaceuticals - Watertown, Massachuse
Slide 2: Zelicapavir (EDP-938): N-Protein Inhibitor for RSV
Zelicapavir (EDP-938): N-Protein Inhibitor for RSV • N-inhibitor in clinical development for RSV – Replication inhibitor: shuts down the production of new RSV virions (vs. fusion inhibitors that block viral entry) • Granted Fast Track designation by the FDA • Strong preclinical profile – Nanomolar p
Slide 3: Zelicapavir Phase 2b RSV High-Risk Adult Study: Design & Objectives
Zelicapavir Phase 2b RSV High-Risk Adult Study: Design & Objectives • Primary Objective: Double-Blind Treatment Phase 5 days Time to resolution** of RSV 186 adults with at least LRTD symptoms (RiiQTM one of the following: Placebo (QD) symptom scale) • COPD 28 Day Follow-up – Shortness of breath, whe
Slide 4: Patient Disposition
Zelicapavir Phase 2b RSV High-Risk Adult Study: Patient Disposition Randomized (n=187) Randomized in error (n=1) Randomized and Dosed (n=186) Safety Population: Placebo (n=65)* Zelicapavir (n=121)* All patients who received study drug Efficacy Population: Placebo (n=60) Zelicapavir (n=115) All patie
Slide 5: Baseline Characteristics (Safety & HR3 Population)
Zelicapavir Phase 2b RSV High-Risk Adult Study: Baseline Characteristics (Safety & HR3 Population) • Baseline characteristics were balanced across treatment groups • Majority of patients (~2/3) enrolled within 48 hours of symptom onset prior to randomization Safety Population HR3 Population* Zelicap
Slide 6: Baseline Characteristics (Safety & HR3 Population)
Zelicapavir Phase 2b RSV High-Risk Adult Study: Baseline Characteristics (Safety & HR3 Population) • Baseline characteristics were balanced across treatment groups Safety Population HR3 Population* Zelicapavir Placebo Zelicapavir Placebo Description (N=121) (N=65) (N=92) (N=50) CHF – n (%) 27 (22.3)
Slide 7: Favorable Safety Profile
Zelicapavir Phase 2b RSV High-Risk Adult Study: Favorable Safety Profile • Adverse events (AEs) were similar between zelicapavir dosing groups and placebo • No AEs led to treatment discontinuation or study withdrawal in zelicapavir group Zelicapavir Placebo Description (N=121) (N=65) Treatment emerg
Slide 8: Faster Time to Complete Symptom Resolution Across Multiple RiiQ Measures
Zelicapavir Phase 2b RSV High-Risk Adult Study: Faster Time to Complete Symptom Resolution Across Multiple RiiQ Measures Efficacy Population HR3 Population* 20 7.2d (34%) 18 Placebo 3.6d 6.7d (19%) (35%) 16 Zelicapavir symptom resolution by RiiQ 2.2d Median days to complete 14 (14%) 3.0d (20%) 12 0.
Slide 9: Symptom Summary for Zelicapavir Compared to Placebo
Zelicapavir Phase 2b RSV High-Risk Adult Study: Symptom Summary for Zelicapavir Compared to Placebo Symptoms Measured by RiiQ • Faster time to complete resolution of all RSV symptoms to absent – Symptom reduction of ~one week in the HR3 population for all 13 RSV symptoms and total RiiQ • No effect o
Slide 10: Hospitalization and Death Endpoints
Zelicapavir Phase 2b RSV High-Risk Adult Study: Hospitalization and Death Endpoints • Lower hospitalization rate for patients treated with zelicapavir Placebo Zelicapavir All-cause-hospitalizations 5.0% (3/60) 1.7% (2/115) RSV-associated hospitalizations • Blinded investigator attribution 5.0% (3/60
Slide 11: Virology Results for Zelicapavir Compared to Placebo
Zelicapavir Phase 2b RSV High-Risk Adult Study: Virology Results for Zelicapavir Compared to Placebo • Larger viral load decline at end of treatment (Day 5) RSV PCR viral load decline of 0.7 log for HR3 – Efficacy Population: 0.6 log population at the end of treatment – HR3 population: 0.7 log • Gre
Slide 12: Pharmacokinetics
Zelicapavir Phase 2b RSV High-Risk Adult Study: Pharmacokinetics • Zelicapavir target exposures were achieved, and were consistent with exposures observed in previously treated subjects • Mean predose (Ctrough) concentrations were 1100 and 1141 ng/mL on Days 3 and 5, respectively Visit n Mean % CV D
Slide 13: Conclusions
Zelicapavir Phase 2b RSV High-Risk Adult Study: Conclusions • Zelicapavir demonstrated compelling results on multiple clinically meaningful endpoints measuring different aspects of RSV disease Up to one week improvement in complete symptom resolution Statistically significant improvement in PGI-