Slide 1: Phase 2 Study of Zelicapavir in Children: RSVPEDs Topline Results
Phase 2 Study of Zelicapavir in Children: RSVPEDs Topline Results December 9, 2024 Exhibit 99.2
Slide 2: Forward Looking Statements Disclaimer
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Slide 3: Enanta Pipeline
DISEASE TARGET DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET Virology: Liver Hepatitis C Virus Protease Hepatitis B Virus Core Virology: Respiratory Respiratory Syncytial Virus N-Protein L-Protein COVID-19 3CL Protease Immunology: Type 2 Immune Diseases Chronic Spontaneous Urticaria*** KIT At
Slide 4: RSV at a Glance
Populations at higher risk for severe illness: Pediatrics (infants and children) High-risk adults (>65 yrs, COPD, asthma, CHF) Immunocompromised (e.g., HIV, transplant) Respiratory Syncytial Virus (RSV) RSV at a Glance Children < 5 years2 Adults > 65 years3 33M global cases 3M global hospitalization
Slide 5: Zelicapavir (EDP-938): N-Protein Inhibitor for RSV
Zelicapavir is currently the only N-inhibitor in clinical development for RSV Replication inhibitor: shuts down the production of new virions (vs fusion inhibitors which block viral entry) Granted Fast Track designation by the FDA Strong preclinical profile Nanomolar potency against RSV-A and RSV-B
Slide 6: Phase 2 Study of Zelicapavir in Children: RSVPEDs Topline Results
Phase 2 Study of Zelicapavir in Children: RSVPEDs Topline Results A phase 2, randomized, double-blind, placebo-controlled, 2-part study to evaluate EDP‑938 regimens in Subjects aged 28 days to 36 months infected with respiratory syncytial virus
Slide 7: Design & Objectives
Zelicapavir Phase 2 Pediatric Study: Design & Objectives ~90 patients Dosed in 2 age cohorts: ≥28 days to <6 months ≥6 months to ≤36 months Double-Blind Treatment Phase 5 days Part 1: MAD vs Placebo Part 2: Selected dose from Part 1 vs Placebo Day 1 Day 5 Day 28 23 Day Follow-up Primary Objectives o
Slide 8: Conclusions
Well tolerated, with favorable safety profile No adverse events leading to treatment discontinuation or study withdrawal Antiviral effect observed for the primary and secondary virology endpoints in overall population Viral load decline of 1.4 log at the end of treatment in Part 2 Viral load decline
Slide 9: Patient Disposition
Zelicapavir Phase 2 Pediatric Study: Patient Disposition # Two patients discontinued the study after receiving the first dose ## One patient discontinued the study after receiving 2 doses * One patient randomized to placebo was treated with zelicapavir in error. Data for this patient are in the zeli
Slide 10: Baseline Characteristics (Safety Population)
Zelicapavir Phase 2 Pediatric Study: Baseline Characteristics (Safety Population) Baseline characteristics were balanced across treatment groups Majority hospitalized at enrollment Mean duration of symptoms prior to randomization of 4 days Description Zelicapavir (pooled) (N=70) Placebo (pooled) (N=
Slide 11: Exhibited Favorable Safety Profile in Children
Adverse events (AEs) were similar between zelicapavir dosing groups and placebo No adverse events led to treatment discontinuation or study withdrawal Zelicapavir Phase 2 Pediatric Study: Exhibited Favorable Safety Profile in Children Description Zelicapavir (pooled) (N=70) Placebo (pooled) (N=26) T
Slide 12: AEs Occurring in More than One Patient in Any Group
Zelicapavir Phase 2 Pediatric Study: AEs Occurring in More than One Patient in Any Group Preferred Term Zelicapavir (pooled) (N=70) Placebo (pooled) (N=26) Diarrhea 7 (10.0%) 1 (3.8%) Rash 3 (4.3%) 1 (3.8%) Otitis media acute 2 (2.9%) 1 (3.8%) Eczema 2 (2.9%) 1 (3.8%) Thrombocytosis 2 (2.9%) 0 (0%)
Slide 13: Achieved Target Exposure Levels in Children
Goal was to achieve similar drug exposures to the exposures proven to be efficacious in the Phase 2 adult challenge study Target drug exposures achieved across all age groups and dosing cohorts (Parts 1 and 2) A dose of 5 mg/kg was selected for age ≥ 28 days to <12 months A dose of 7.5 mg/kg was sel
Slide 14: Primary Endpoint – RSV PCR Viral Load for All Patients (Part 1 & 2)
Zelicapavir Phase 2 Pediatric Study: Primary Endpoint – RSV PCR Viral Load for All Patients (Part 1 & 2) Trend toward greater viral load decline in patients treated with zelicapavir compared to placebo LS Mean Viral Load Change from Baseline (+/-SE) (log10 copies/mL) Study Day Zelicapavir (n=69) Pla
Slide 15: Primary Endpoint of Part 2: RSV PCR Viral Load
Zelicapavir Phase 2 Pediatric Study: Primary Endpoint of Part 2: RSV PCR Viral Load Viral load decline of 0.96 log at Day 3 and 1.41 log at Day 5 Zelicapavir (n=34) Placebo (n=10) LS Mean Viral Load Change from Baseline (+/-SE) (log10 copies/mL) Study Day Δ = -0.96 Δ = -1.41 Δ = -0.43 Δ = 0.84
Slide 16: Prespecified mITT-3 Population: RSV PCR Viral Load
Zelicapavir Phase 2 Pediatric Study: Prespecified mITT-3 Population: RSV PCR Viral Load Viral load decline of 0.88 log at Day 3 and 1.18 log at Day 5 LS Mean Viral Load Change from Baseline (+/-SE) (log10 copies/mL) Study Day Zelicapavir (n=28) Placebo (n=10) Δ = -0.88 Δ = -1.18 Δ = -0.57 Δ = -0.20
Slide 17: Secondary Endpoint: Proportion with Undetectable Viral Load over Time
Zelicapavir Phase 2 Pediatric Study: Secondary Endpoint: Proportion with Undetectable Viral Load over Time Greater proportion of zelicapavir treated patients had undetectable viral load at Days 5 and 9 compared to placebo Proportion of Patients with Undetectable RSV RNA (%) Study Day Overall Efficac
Slide 18: Secondary Endpoint: Time to Undetectable Viral Load
Zelicapavir Phase 2 Pediatric Study: Secondary Endpoint: Time to Undetectable Viral Load Zelicapavir showed a qualitative improvement in time to undetectable viral load at early timepoints, although median time to undetectable viral load was similar between groups Probability of Detectable RSV RNA (
Slide 19: Virology Summary
Antiviral effect observed for the primary and secondary virology endpoints in overall population Viral load decline in Part 2 of 1.0 log at Day 3 and 1.4 log at Day 5 vs placebo Rapid and robust virology effects observed in prespecified subset of patients who were randomized within 3 days of symptom
Slide 20: Exploratory Endpoint: RSV Signs/Symptoms
Zelicapavir Phase 2 Pediatric Study: Exploratory Endpoint: RSV Signs/Symptoms No validated symptom tool approved by regulatory agencies available for pediatric RSV RESOLVE-P (RESpiratory ObservabLE Reported Outcome-Pediatric) Proprietary tool in development by Enanta in alignment with regulatory age
Slide 21: Exploratory Endpoint – RSV Signs/Symptoms
Zelicapavir Phase 2 Pediatric Study: Exploratory Endpoint – RSV Signs/Symptoms Study was not powered to evaluate effects on signs/symptoms ReSViNET: No difference in signs/symptoms between treatment arm and placebo RESOLVE-P: Small patient dataset (n=15) Trend towards greater sign/symptom reduction
Slide 22: Conclusions
Well tolerated, with favorable safety profile No adverse events leading to treatment discontinuation or study withdrawal Antiviral effect observed for the primary and secondary virology endpoints in overall population Viral load decline of 1.4 log at the end of treatment in Part 2 Viral load decline
Slide 23: Phase 2 Study of Zelicapavir in Children: RSVPEDs Topline Results
Phase 2 Study of Zelicapavir in Children: RSVPEDs Topline Results December 9, 2024