Structure Therapeutics, Inc. · NASDAQ:GPCR
Structure Therapeutics — Corporate Update (September 2023)
24 slides from Structure Therapeutics's corporate update, Sep 29, 2023
Slide 1: GSBR-1290 Phase 1b MAD Results September 29, 2023
GSBR-1290 Phase 1b MAD Results September 29, 2023
Slide 2: Attendees
Attendees • Raymond Stevens, Ph.D., Chief Executive Officer • Mark Bach, M.D., Ph.D., Chief Medical Officer • Blai Coll, M.D., Ph.D., VP Clinical Development • Jun Yoon, Chief Financial Officer • Danielle Keatley, Investor Relations
Slide 3: Forward looking statements
Forward looking statements This presentation contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be deemed forward-looking s
Slide 4: Agenda
Agenda • Opening Remarks (Ray Stevens) • GSBR-1290 Phase 1b MAD Study Top Line Data (Blai Coll) • GSBR-1290 Program Update and Next Steps (Mark Bach) • Conclusion (Ray Stevens) • Q&A
Slide 5: Disrupting the GLP-1R peptide-dominated market with oral small molecules
Disrupting the GLP-1R peptide-dominated market with oral small molecules 2005/2010 2014 2017 2019 2021 2022 Our powerful platform enables a franchise approach to potentially replace the marketed peptides GLP-1R GLP-1R/GIPR Peptide Drugs on the Market Incretin drugs evolution – Aimed at improving con
Slide 6: Positive results from Phase 1b MAD study and program update
Positive results from Phase 1b MAD study and program update • GSBR-1290 (Oral small molecule GLP-1R agonist) demonstrates once-a-day dosing • Topline data from Phase 1b MAD study (4 wk): - Significant weight reduction with once-a-day dosing at 28 days - Encouraging safety and tolerability profile wi
Slide 7: Study Top Line Data
GSBR-1290 Phase 1b MAD Study Top Line Data (Blai Coll, M.D., Ph.D., VP Clinical Development)
Slide 8: Study design
GSBR-1290 Phase 1b MAD study design: Key eligibility criteria Cohort 1 n=8 (6:2) 5 mg 15 mg 30 mg 60 mg Follow up Cohort 3 n=8 (6:2) 0 1 2 3 4 5 weeks 10 mg 30 mg Follow up 0 1 2 3 4 5 weeks Cohort 2 n=8 (6:2) 10 mg 30 mg 60 mg 90 mg Follow up Healthy overweight/obese adult men and women BMI ≥27.0 a
Slide 9: Study: Participant disposition
GSBR-1290 Phase 1b MAD study: Participant disposition GSBR-1290 Phase 1b MAD study Randomized (N=24) GSBR-1290 30 mg (N=6) GSBR-1290 60 mg (N=6) GSBR-1290 90mg (N=6) Placebo (N=6) Discontinue study drug due to AE 0 0 0 0 Dose down titrated or hold 0 0 0 0 Completed study 6 (100%) 6 (100%) 5 (83.3%)*
Slide 10: Baseline characteristics
Mean (SD) Median GSBR-1290 30 mg (N=6) GSBR-1290 60 mg (N=6) GSBR-1290 90 mg (N=6) Placebo pooled (N=6) Age, years 49.7 (9.1) 54.5 41.5 (5.4) 43 49.8 (19.9) 48 45.2 (14.6) 41 Sex, female N (%) 2 (33) 4 (66) 2 (33) 5 (83) Weight, Kg 104.6 (19.5) 103.5 93.8 (11.7) 89.1 88.7 (18) 89.8 92.2 (13.3) 90.2
Slide 11: Efficacy-Clinical activity: weight change at Day 28
-0.5% -1.6% -5.2% -5.4% -6.0% -5.0% -4.0% -3.0% -2.0% -1.0% 0.0% Placebo 30 mg 60 mg 90 mg % Weight change from baseline to Day 28 GSBR-1290 Phase 1b MAD study: Efficacy-Clinical activity Positive signs of clinical activity at Day 28 with once-a-day dosing of GSBR-1290 • Changes in body weight (BW)
Slide 12: Efficacy-Clinical activity: fasting plasma glucose
GSBR-1290 Phase 1b MAD study: Efficacy-Clinical activity Changes in mean fasting plasma glucose placebo-adjusted GSBR-1290 30 mg GSBR-1290 60 mg GSBR-1290 90 mg FPG, mg/dL Consistent decrease in fasting plasma glucose (FPG) at ascending doses of GSBR-1290 -8 -7.8 -7.6 -7.4 -7.2 -7 -6.8 -6.6 -6.4 Mea
Slide 13: Efficacy-Clinical activity: changes in heart rate
GSBR-1290 Phase 1b MAD study: Efficacy-Clinical activity Changes in heart rate placebo-adjusted • Higher pulse rate observed with GSBR-1290 as expected for the class • Increases consistent with other GLP-1RAs 1,2 • No dose-dependency observed 1,2 Granhall C, Donsmark M, Blicher TM, et al. Clin Pharm
Slide 14: Safety and Tolerability: Summary of TEAEs
GSBR-1290 Phase 1b MAD study: Safety and Tolerability Summary of Treatment Emergent Adverse Events (TEAEs) Event, N (%) GSBR-1290 30 mg (N=6) GSBR-1290 60 mg (N=6) GSBR-1290 90 mg (N=6) Placebo pooled (N=6) Any TEAE 5 (83) 6 (100) 6 (100) 4 (66) Any TEAE by maximum severity Mild 4 (66) 4 (66) 3 (50)
Slide 15: Safety and Tolerability: most common TEAEs GI-related
GSBR-1290 Phase 1b MAD study: Safety and Tolerability Most common TEAEs were GI-related as expected for GLP1-RAs Event, N (%) GSBR-1290 30 mg (N=6) GSBR-1290 60 mg (N=6) GSBR-1290 90 mg (N=6) Placebo pooled (N=6) Nausea 1 (16.7) 5 (83.3) 5 (83.3) 0 Vomiting 0 3 (50) 3 (50) 0 Diarrhea 1 (16.7) 3 (50)
Slide 16: Safety and Tolerability: temporal course and severity of nausea
GSBR-1290 Phase 1b MAD study: Safety and Tolerability Temporal course and severity of nausea 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Week 1 Week 2 Week 3 Week 4 GSBR1290 90 mg mild GSBR-1290 90 mg moderate Placebo 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Week 1 Week 2 Week 3 Week 4 GSBR1290 60 mg mild
Slide 17: Safety and Tolerability: temporal course and severity of vomiting
GSBR-1290 Phase 1b MAD study: Safety and Tolerability Temporal course and severity of vomiting 0% 10% 20% 30% 40% 50% 60% Week 1 Week 2 Week 3 Week 4 GSBR1290 60 mg mild GSBR-1290 60 mg moderate Placebo 0% 10% 20% 30% 40% 50% 60% Week 1 Week 2 Week 3 Week 4 GSBR1290 90 mg mild GSBR-1290 90 mg modera
Slide 18: Promising oral small molecule GLP-1R agonist
GSBR-1290: Promising oral small molecule GLP-1R agonist Promising safety and tolerability profile Once-a-day dosing Encouraging weight reduction at 4 weeks GSBR-1290 exhibited encouraging safety and tolerability profile with no adverse event-related discontinuations at all doses at 4wk GSBR-1290 ear
Slide 19: Program Update and Next Steps
GSBR-1290 Program Update and Next Steps (Mark Bach, M.D., Ph.D., Chief Medical Officer)
Slide 20: Phase 2a study in T2DM and overweight/obese
GSBR-1290 Phase 2a study in T2DM and overweight/obese over 12 weeks Cohort 5A (n=18) PBO PBO PBO PBO PBO PBO Follow up Cohort 5B (n=10) 5 mg 10 mg 20 mg 30 mg 45 mg 45 mg X 7 weeks Follow up Cohort 5C (n=26) 5 mg 15 mg 30 mg 60 mg 90 mg 90 mg X 7 weeks Follow up 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 we
Slide 21: Program progress and upcoming milestones
GSBR-1290: Program progress and upcoming milestones 2023 2024 Phase 1b/MAD data (4 wk) • N=24, healthy overweight/obese participants, up to 90 mg • No adverse event-related discontinuations up to 90 mg • Statistically significant reductions in weight at 60 and 90 mg (up to 4.9% placebo-adjusted) Pha
Slide 22: Closing
Closing (Raymond Stevens, Ph.D., CEO)
Slide 23: Next steps: Continue to execute on oral incretin franchise strategy
Next steps: Continue to execute on oral incretin franchise strategy GSBR-1290 (Oral GLP-1R) GLP-1R+ Combo (GLP-1R/GIPR) GLP-1R+ Combo (GLP-1R/Amylin) 2023 2024 Phase 1b/MAD data (4 wk) Phase 2a T2D data (12 wk) JP PK/ethno-bridging study (4 wk) Phase 2a Obesity data (12 wk) Capsule to tablet PK/brid
Slide 24: Thank you!
Thank you! CONTACT US FOR ADDITIONAL INFORMATION: Email: ir@structuretx.com http://www.structuretx.com
Structure Therapeutics — Corporate Update (September 2023) on 6ix