Slide 1: Top-Line Results of the Phase 2a Part of the Phase 2/3 Trial of S-217622
Top-Line Results of the Phase 2a Part of the Phase 2/3 Trial of S-217622, the COVID-19 Therapeutic Drug February 7, 2022 Isao Teshirogi, Ph.D. President and CEO
Slide 2: Phase 2a Part (of Phase 2/3 trial)
Phase 2a Part（of Phase 2/3 trial） Mild/moderate and asymptomatic/only mild Mild/moderate and asymptomatic/only mild symptoms Subjects SARS-CoV-2-infected subjects symptoms SARS-CoV-2-infected subjects ＜Common criteria＞ Clinical trial Multicenter, randomized, placebo-controlled, • 12 to < 70 years of
Slide 3: Main Endpoints
Main Endpoints 【Antiviral effect】 → Primary endpoint Change from baseline in SARS-CoV-2 viral titer at each time point （Viral titer: Amount of infectious virus (living virus) contained in the sample） 【Antiviral effect】 • Change from baseline in SARS-CoV-2 viral RNA at each time point （Viral RNA: Amo
Slide 4: Key Demographics of Subjects
Key Demographics of Subjects Background information in the ITT* population low dose high dose placebo N=16 N=14 N=17 Male 8 8 13 Sex Female 8 6 4 Min 22 23 16 Age Max 59 63 61 mild/moderate 14 12 14 Severity asymptomatic/ only mild 2 2 3 Vaccination of Yes 14 (87.5%) 12 (85.7%) 12 (70.6%) SARS-CoV-2
Slide 5: Efficacy
Efficacy – Antiviral effect (Viral titer/RNA) – Clinical Symptom improvement – Effect in preventing exacerbations
Slide 6: Antiviral Effect: Viral Titer, Viral RNA
Antiviral Effect: Viral Titer, Viral RNA Mean change from baseline in viral titer Mean change from baseline in amount of viral RNA vs Placebo group * < 0.05 vs Placebo group * < 0.05 ANCOVA with covariates of study cohorts (mild/moderate ANCOVA with covariates of study cohorts (mild/moderate or asym
Slide 7: Antiviral Effect: Proportion of Patients with Positive Viral Titer
Antiviral Effect: Proportion of Patients with Positive Viral Titer Proportion of patients with viral titer positivity Day 1 Day 2 Day 4 Day 6 Before the 1st dose After the 1st dose After the 3rd dose After the 5th dose vs Placebo group *< 0.05 100% Mantel-Haenszel test stratified by study cohorts (m
Slide 8: Antiviral Effect: Time to the First Negative SARS-CoV-2 Viral Titer
Antiviral Effect: Time to the First Negative SARS-CoV-2 Viral Titer Kaplan-Meier Plot for time to the First Negative SARS-CoV-2 Viral Titer 100 S-217622: S-217622: Placebo SARS-CoV-2 viral titer (%) 80 Proportion of negative low dose high dose N = 15 N = 13 N = 14 60 50% Median (hours) 61.3 62.7 111
Slide 9: Clinical improvement: Change from Baseline in COVID-19 Symptom Score
Clinical improvement: Change from Baseline in COVID-19 Symptom Score Mean change from baseline in 12 COVID-19 symptom total score Change in total score of 12 symptoms 0.0 S-217622 high dose -2 S-217622 low dose Placebo -4 Mean ± standard deviation -6 -8 12 symptoms of COVID-19 -10 Systemic symptom
Slide 10: Effect in preventing exacerbations
Effect in preventing exacerbations 8-Point Ordinal Scale* exacerbation rate (exploratory analysis) (Proportion of first exacerbated subjects with 3 or higher on 8-Point Ordinal Scale* score at any point after the treatment) ⇒Proportion of subjects whose condition worsened after the treatment and was
Slide 11: Safety
for youl_/) Safety @®SHIONOGI
Slide 12: Treatment-emergent adverse events (TEAE) / Treatment-related TEAE
Treatment-emergent adverse events (TEAE) / Treatment-related TEAE Treatment-emergent adverse events (TEAE) S-217622: low dose S-217622: high dose Placebo N = 21 N = 23 N = 24 Subjects with any TEAE 11 16 9 Percentage of subjects 52.4% 69.6% 37.5% Treatment-related TEAE S-217622: low dose S-217622: h
Slide 13: Treatment-emergent adverse events (TEAE) (5% or more)
Treatment-emergent adverse events (TEAE) （5% or more） Treatment-emergent adverse events (TEAE) （5% or more） S-217622: low dose S-217622: high dose Placebo N = 21 N = 23 N = 24 Subjects with any TEAE (Percentage of subjects) 11（52.4%） 16（69.6%） 9（37.5%） Nasopharyngitis 2（9.5%） 0 0 Headache 1（4.8%） 3（
Slide 14: Treatment-related TEAE (5% or more)
Treatment-related TEAE (5% or more) Treatment-related TEAE (5% or more) S-217622: low dose S-217622: high dose Placebo N = 21 N = 23 N = 24 Subjects with any treatment-related 5（23.8%） 10（43.5%） 0 TEAE (percentage of subjects) High density lipoprotein (HDL) decreased 3（14.3%） 8（34.8%） 0 Blood trigly
Slide 15: Summary
Summary • Antiviral effect – The S-217622 arms showed a significant difference compared to the placebo group with respect to each of the following: > Rapid reductions in viral titer and viral RNA > On day 4, the proportion of subjects with positive viral titer decreased by approximately 60- 80% comp
Slide 16: S-217622: Current Status and Future Plans
S-217622：Current Status and Future Plans Feb. 7, 2022 2021FY 2022FY 9 10 11 12 1 2 3 4 5 6 7 8 9 10 Phase 2/3 trial Mild/moderate: Plan to Initiate Phase 3 Phase 2b part Phase 3 part part on February 8, 2022 Phase 2a part Asymptomatic/only mild symptoms: Phase 2b/3 part Continue Phase 2b/3 part Phas
Slide 17: Appendix
for youl_/) Appendix @®SHIONOGI
Slide 18: Nonclinical Efficacy: Activity against Omicron Variant
Nonclinical Efficacy: Activity against Omicron Variant Activity against omicron variant In vitro assay using VeroE6T cells Major mutation site SARS-CoV-2 variant EC50 (μM) Spike-protein 3CL-protease WK-521 strain 0.37 - - α variant 0.31/0.46/0.33 N501Y, D614G - (QHN001/QHN002/QK002) β variant 0.40 K
Slide 19: Reference: Mean Change from Baseline in Virus RNA (other antivirals)
Reference: Mean Change from Baseline in Virus RNA (other antivirals) Molnupiravir Phase 2 *1 PAXLOVID HR Phase 3 *2 REGEN-COV HR Phase 3 *3 Molnupiravir Nirmatrelvir 300 mg REGEN-COV Placebo Placebo Placebo 800 mg ritonavir 100 mg 2,400 mg Day 3 N 51 56 Mean* -1.050 -0.847 Diff* vs placebo -0.203 --
Slide 20: Forward-Looking Statements
Forward-Looking Statements • Forecast or target figures in this material are neither official forecasts of earnings and dividends nor guarantee of target, achievement and forecasts, but present the midterm strategies, goals and visions. Official earnings guidance should be referred to in the disclos