Enanta Pharmaceuticals, Inc. · NASDAQ:ENTA

Enanta Pharmaceuticals — Corporate Update (June 2019)

17 slides from Enanta Pharmaceuticals's corporate update, Jun 14, 2019

  1. Slide 1: EDP 938-101 Phase 2a Study: Human Challenge Study Topline Results

    From Chemistry to Cures EDP 938-101 Phase 2a Study: Human Challenge Study Topline Results Conference Call and Webcast June 14, 2019 ENANTA Pharmaceuticals 1

  2. Slide 2: Forward Looking Statements Disclaimer

    Forward Looking Statements Disclaimer This presentation contains forward-looking statements concerning our RSV program, as well as our plans, objectives and expectations for EDP-938 and its development. Any statements contained herein that are not statements of historical facts may be deemed to be f

  3. Slide 3: RSV Infection: An Unmet Medical Need

    RSV Infection: An Unmet Medical Need • Respiratory Syncytial Virus (RSV) represents an important global health challenge with significant morbidity and mortality in infants, elderly, and immunocompromised populations • No approved vaccine to treat or prevent RSV mediated disease is available - The o

  4. Slide 4: RSV Life Cycle and Targets

    RSV Life Cycle and Targets N inhibitors: EDP-938 ENANTA Pharmaceuticals EDP 938-101 TOPLINE RESULTS 4 Enanta Pharmaceuticals 2019 | 4

  5. Slide 5: EDP-938 A Novel, Potent RSV N-Protein Inhibitor

    EDP-938 A Novel, Potent RSV N-Protein Inhibitor • Active in vitro against RSV-A and -B clinical isolates 4-8 • Demonstrated excellent in vivo efficacy, reducing viral load by >4-log in a pre-clinical primate RSV infection model 4-8 • Phase 1 complete in healthy subjects 9 - Safe and well-tolerated o

  6. Slide 6: Phase 2a Challenge Study (EDP 938-101) Study Design and Procedures

    Phase 2a Challenge Study (EDP 938-101) Study Design and Procedures Quarantine Before Dosing Initiation After Dosing Initiation Follow-up Screening Study Inoculation Study Dosing Day 0 Study Day Study Day Day -2/-1 Day Day 2 to ≤ 5 For 5 days 12 28 Admission Viral Monitor for Dosing Discharge Final s

  7. Slide 7: Powered for Both Viral Load and Total Symptom Score (TSS)

    EDP 938-101 Study Design Powered for Both Viral Load and Total Symptom Score (TSS) • Study designed with an 80% power to detect a 70% reduction with a two-sided alpha=0.05 and assuming an infection rate of 56% - RSV Viral Load AUC: Primary Efficacy Endpoint • To detect a 70% reduction in RT-qPCR AUC

  8. Slide 8: EDP 938-101: Participant Disposition

    EDP 938-101: Participant Disposition Day -56 to Day -3 Screening (n=155) Did not meet inclusion & exclusion criteria (n=40) Day -2 or Day -1 Quarantined and inoculated with RSV-A Memphis 37b virus (n=115) Day 1 to Day 5 Randomization (n=115) Placebo QD EDP-938 600 mg QD EDP-938 500mg LD + 300 mg BID

  9. Slide 9: Rapid and Sustained Reduction in Viral Load in Both Active Arms Compared to Placebo

    Robust Antiviral Effect Rapid and Sustained Reduction in Viral Load in Both Active Arms Compared to Placebo Dosing Period First Dose ENANTA Pharmaceuticals EDP 938-101 TOPLINE RESULTS 9 Enanta Pharmaceuticals 2019 | 9

  10. Slide 10: Highly Statistically Significant Reduction in Both EDP-938 Arms Compared to Placebo

    Highly Statistically Significant Reduction in Both EDP-938 Arms Compared to Placebo - No Statistically Significant Difference Between the Two Dosing Regimens EDP-938 EDP-938 500 mg LD + Placebo 600 mg QD 300 mg BID N 25 31 30 Viral load AUC mean (SD) 203.95 (173.50) 217.71 (217.55) 790.15 (408.80) (

  11. Slide 11: EDP-938 Shows a Rapid and Sustained Attenuation of RSV Symptoms Compared to Placebo

    EDP-938 Shows a Rapid and Sustained Attenuation of RSV Symptoms Compared to Placebo Dosing Period First Dose ENANTA Pharmaceuticals EDP 938-101 TOPLINE RESULTS 11 Enanta Pharmaceuticals 2019 | 11

  12. Slide 12: Both EDP-938 Regimens Demonstrated Highly Statistically Significant Attenuation of RSV Symptoms

    Both EDP-938 Regimens Demonstrated Highly Statistically Significant Attenuation of RSV Symptoms Compared to Placebo - No Statistically Significant Difference Between the Two Dosing Regimens EDP-938 EDP-938 500 mg LD/300 Placebo 600 mg QD mg BID N 25 31 30 AUC Total Symptom Score mean (SD) 124.47 (11

  13. Slide 13: EDP-938 Was Safe and Well Tolerated in the RSV Human Challenge Study

    EDP-938 Was Safe and Well Tolerated in the RSV Human Challenge Study • EDP-938 demonstrated a favorable safety profile over 5 days of dosing through Day 28 of follow-up • Comparable to placebo for both QD and BID dosing groups - No significant single event or pattern of events was observed compared

  14. Slide 14: Summary: EDP-938, A Highly Efficacious and Safe RSV N-Inhibitor

    Summary: EDP-938, A Highly Efficacious and Safe RSV N-Inhibitor in the Human Challenge Study • Primary and Key Secondary Efficacy Endpoints were achieved with high statistical significance at both dose levels (600mg QD and LD 500mg + 300mg BID) after 5 days of dosing • EDP-938 mean Ctrough concentra

  15. Slide 15: Acknowledgments

    Acknowledgments • We extend our thanks to the subjects who participated in this study and the hVIVO team and site personnel for their conduct of the study ENANTA Pharmaceuticals EDP 938-101 TOPLINE RESULTS 15 Enanta Pharmaceuticals 2019 | 15

  16. Slide 16: References

    References 1. Kimpen JL, Schaad UB. Treatment of respiratory syncytial virus bronchiolitis: 1995 poll of members of the European Society for Paediatric Infectious Diseases. Pediatr Infect Dis J. 1997;16(5):479-81. 2. De Vincenzo JP. Therapy of respiratory syncytial virus infection. Pediatr Infect Di

  17. Slide 17: From Chemistry to Cures

    From Chemistry to Cures ENANTA Pharmaceuticals 17

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