Vera Therapeutics, Inc. · NASDAQ:VERA
Vera Therapeutics — Technical Presentation (June 2023)
15 slides from Vera Therapeutics's technical presentation, Jun 17, 2023
Slide 1: 36-Week Efficacy & Safety of Atacicept 150 mg in the ORIGIN Phase 2b Study
36-Week Efficacy & Safety of Atacicept 150 mg in the ORIGIN Randomized, Double-blind, Placebo-controlled Phase 2b Study in IgAN and Persistent Proteinuria Richard Lafayette1, Bart Maes2, Celia Lin3, Sean Barbour4, Richard Phoon5, Sung Gyun Kim6, Vladimir Tesar7, Jürgen Floege8, Vivekanand Jha9, Jona
Slide 2: Disclosure of Interest and Forward Looking Statements
Disclosure of Interest for Richard Lafayette • Consultant for Vera, Omeros, Calliditas, Chinook, Alexion, Otsuka, Novartis, GSK, Alnylam • Employee of Stanford University Medical Center, which has received research funding from Vera, Omeros, ChemoCentryx, Chinook, Alexion, Otsuka, Calliditas, Roche,
Slide 3: Atacicept: Dual Inhibitor (BAFF/APRIL) of B Cells and Plasma Cells
Atacicept: Dual Inhibitor (BAFF/APRIL) of B Cells and Plasma Cells with Potential to Address Multiple Autoimmune Diseases BAFF APRIL Atacicept • Fully humanized TACI-Ig fusion protein, subcutaneously administered • Low nanomolar potency vs BAFF (Kd 1.45 nM) and APRIL (Kd 0.672 nM) • Reduces overstim
Slide 4: Atacicept Targets Upstream Hits of IgAN Pathogenesis
Atacicept Targets Upstream Hits of IgAN Pathogenesis B Cell Maturation and Class-Switching Systemic Circulation Glomerulonephritis Lymphoid tissue BAFF IgA1 2 Plasma cell Plasma cell 6 mistrafficking to the Gd-IgA1-containing APRIL systemic circulation immune complexes deposit in glomeruli 1 B cell
Slide 5: ORIGIN Phase 2b IgAN Trial: Study Design and Objectives
ORIGIN Phase 2b IgAN Trial: Study Design and Objectives Multinational, randomized, placebo-controlled trial Double-Blind Treatment Open-label Extension Placebo n=30 Atacicept 25 mg qwk n=15 Atacicept 150 mg qwk Atacicept 75 mg qwk n=30 Atacicept 150 mg qwk n=30 Week 0 24 36 96/ET 1° Endpoint 2° Endp
Slide 6: Patient Disposition
Patient Disposition Screened, n=232 Screen Failures, n=116 Randomized and Treated, n=116 All Atacicept, n=82 Placebo, n=34 n=82 Safety and ITT population n=34 n=73 (89%) Prespecified Week 36 PP analysis n=26 (76%) Excludes patients with protocol violations as identified by blinded third-party CRO Di
Slide 7: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics Overall Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo Mean ± SD or n (%) n=116 n=16 n=33 n=33 n=34 Age, y 39 ± 12.6 40 ± 15.0 41 ± 12.6 38 ± 11.4 39 ± 13.0 Male sex 69 (59) 9 (56) 19 (58) 22 (67) 19 (56) Race White 62 (53) 7 (44) 12 (36) 17 (52) 2
Slide 8: Mean ± SE % Change from Baseline in UPCR-24h
UPCR % Change with Atacicept 150 mg at Week 36 ITT Analysis PP Analysis1 20 Mean ± SE % Change from Baseline in UPCR-24h 10 3% 5% 0 -10 -20 -30 Δ 35% -33% -40 p=0.012 Δ 43% -40% p=0.003 -50 Placebo Atacicept 150 mg Placebo Atacicept 150 mg n=34 n=33 n=26 n=26 p-values, percentage changes from baseli
Slide 9: Mean ± SE % Change from Baseline in eGFR
eGFR Change with Atacicept 150 mg Through Week 36 15 Mean ± SE % Change from Baseline in eGFR 10 5 1.6% Δ 11% p=0.038 0 5.8 mL/min/1.73 m2 -5 Absolute difference in mean change at week 36 -10 -8.5% -15 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 Week n= Placebo 34 34 34 34 34 30 Atacicept 15
Slide 10: Dose-dependent Reductions Observed in Serum IgG, IgA, and IgM Through Week 36
Dose-dependent Reductions Observed in Serum IgG, IgA, and IgM Through Week 36 IgG IgA IgM 0 0% 0 0 -4% -3% * Mean ± SE % Change from Baseline * * * * -14% * -20 * -20 * -20 * * * * * * -32% * -32% * -37% -40 * -40 * * -40 * * * * * * * -54% * -60 -60 * -60 * -59% -63% * * * * -70% * -73% -80 -80 * *
Slide 11: Mean ± SE % Change from Baseline in Gd-IgA1
Gd-IgA1 % Change Through Week 36 20 Mean ± SE % Change from Baseline 0 -7% * in Gd-IgA1 -20 * * * * -40 * -39% * * -60 * -62% * -64% * * -80 0 4 8 12 16 20 24 28 32 36 Week n= Placebo 33 33 33 33 29 Atacicept 25 mg 16 16 16 15 15 Atacicept 75 mg 33 33 33 33 33 Atacicept 150 mg 32 32 30 30 30 ITT ana
Slide 12: Treatment-Emergent Adverse Events Through Week 36
Treatment-Emergent Adverse Events Through Week 36 Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo Patients, n (%) n=16 n=33 n=33 n=34 TEAEs 11 (69) 24 (73) 25 (76) 27 (79) Study drug-related TEAEs1 6 (38) 17 (52) 19 (58) 14 (41) Serious TEAEs 0 1 (3)2 1 (3)3 3 (9)4 TEAEs leading to study dr
Slide 13: Infections Were Balanced Between Atacicept and Placebo Through Week 36
Infections Were Balanced Between Atacicept and Placebo Through Week 36 Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo Patients, n (%) n=16 n=33 n=33 n=34 Infections1 6 (38) 16 (48) 13 (39) 11 (32) Occurring in >1 patient COVID-19 4 (25) 9 (27) 8 (24) 6 (18) Upper respiratory tract infectio
Slide 14: Conclusions
Conclusions • The Phase 2b trial met its primary endpoint of significant proteinuria reduction at week 24 in IgAN patients at high risk of disease progression • At week 36, patients receiving atacicept 150 mg had a statistically significant 43% reduction in proteinuria compared to placebo • Patients
Slide 15: Thank you to all our ORIGIN Phase 2b study volunteers
Thank you to all our ORIGIN Phase 2b study volunteers and the ORIGIN investigators and study staff Scan for more information about atacicept © 2023 VERA THERAPEUTICS, INC.
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