Vera Therapeutics, Inc. · NASDAQ:VERA
Vera Therapeutics — Corporate Update (January 2023)
30 slides from Vera Therapeutics's corporate update, Jan 3, 2023
Slide 1: Phase 2b Clinical Trial Week 24 Results
© 2023 VERA THERAPEUTICS, INC. Phase 2b Clinical Trial Week 24 Results January 2023
Slide 2: Forward Looking Statements Disclaimer
Forward Looking Statements Disclaimer This material has been made available to you with the consent of Vera Therapeutics, Inc. ("we", "us", "our", or the "Company"). Statements contained in this presentation regarding matters, events or results that may occur in the future are “forward-looking state
Slide 3: Agenda for Today's Meeting
Agenda for Today’s Meeting Opening Remarks ORIGIN Phase 2b Topline Results Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeu
Slide 4: Atacicept for IgA Nephropathy
I © 2023 VERA THERAPEUTICS, INC. Atacicept for IgA Nephropathy Self-administered subcutaneous biologic therapy in development for IgAN Targets the source of IgAN disease, Gd-IgA1 and its immune complexes, by inhibiting two cytokines, BLyS (also known as BAFF) and APRIL, important in B cell and plasm
Slide 5: Summary of Positive Phase 2b Week 24 Results
Summary of Positive Phase 2b Week 24 Results Atacicept 150 mg dose selected for Phase 3 clinical trial, expected to initiate in 1H 2023 Atacicept met primary endpoint at week 24 Achieved statistical significance in 150 mg dose group with 33% reduction in proteinuria from baseline Trend towards furth
Slide 6: Atacicept in IgAN: Development Program Timeline
Atacicept in IgAN: Development Program Timeline JANUS Phase 2a Topline Results1 ORIGIN Phase 2b Trial: Week 24 Topline Results ORIGIN Phase 2b Trial: Week 36 Results Initiation of Phase 3 Trial June 2020 Reported today Expected Q2 2023 Expected 1H 2023 1. Reported original analysis at Barratt J, et
Slide 7: Table of Contents
Table of Contents Opening Remarks ORIGIN Phase 2b Topline Results Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Mars
Slide 8: ORIGIN Phase 2b IgAN Trial: Study Design and Objectives
ORIGIN Phase 2b IgAN Trial: Study Design and Objectives Multinational, randomized, placebo-controlled trial powered for 28% Δ between pooled 75/150 mg arms vs placebo ET = end of trial; RAASi = renin-angiotensin-aldosterone system inhibitor; UPCR = urine protein:creatinine ratio. Week 0 24 1° Endpoi
Slide 9: 30% Reduction in Proteinuria is Known to be Clinically Meaningful in IgAN Patients
30% Reduction in Proteinuria is Known to be Clinically Meaningful in IgAN Patients 1. Inker LA, et al. Am J Kidney Dis 2021;78:340-9.E1; 2. Barratt Lab, University of Leicester; 3. Barratt J, et al. Kidney Int 2022;S0085-2538(22)00836-5; 4. Tarpeyo [package insert]. 2021; 5. Travere press release; A
Slide 10: Multinational, Randomized, Placebo-controlled Phase 2b Trial
Multinational, Randomized, Placebo-controlled Phase 2b Trial Randomized Patients
Slide 11: Patient Disposition
Patient Disposition Safety data includes all post-week 24 visits available at data-cut December 23, 2022. ITT = intent to treat. 1. Discontinued to pursue elective surgery (1) and adverse event (1). 2. Initiated prohibited medication for concomitant disease. Screened, n=232 Randomized and Treated, n
Slide 12: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics Mean ± SD or n (%) Overall n=116 Atacicept 25 mg n=16 Atacicept 75 mg n=33 Atacicept 150 mg n=33 Placebo n=34 Age, y 39 40 41 38 39 Male sex 69 (59) 9 (56) 19 (58) 22 (67) 19 (56) Race White 62 (53) 7 (44) 12 (36) 17 (52) 26 (76) Asian 51 (44) 7 (44) 20 (61)
Slide 13: Atacicept Achieved Statistical Significance on Primary Endpoint
Atacicept Achieved Statistical Significance on Primary Endpoint (75/150 mg), 150 mg, and All Doses Combined 1. Placebo value from individual atacicept dose analysis; 2. Primary analysis. p-value and % change from baseline were estimated from the mixed effect model with repeated measurement (MMRM), i
Slide 14: Trend Towards Further Proteinuria Reduction vs Placebo
n= Placebo 34 34 34 12 All Atacicept 82 81 79 32 Trend Towards Further Proteinuria Reduction in All-Atacicept Group vs Placebo (38% of Patient Data at Week 36) p-value and % change from baseline were estimated from MMRM, including change from baseline in natural log transformed UPCR as the dependent
Slide 15: Stable eGFR Through Week 24
Stable eGFR Through Week 24 in All Atacicept Group n= Placebo 34 34 34 34 34 All Atacicept 82 81 82 81 79 Mean eGFR change from baseline +3 mL/min at week 24 Similar results for atacicept 150 mg alone As expected, week 24 timepoint is too early to observe eGFR decline in placebo eGFR Change Through
Slide 16: Robust Reductions in Gd-IgA1 Through Week 24
Robust Reductions in Gd-IgA1 Through Week 24 n= Placebo 33 33 33 33 Atacicept 25 mg 16 16 16 15 Atacicept 75 mg 33 33 33 32 Atacicept 150 mg 32 32 30 29 Gd-IgA1 % Change Through Week 24 Mean ± SD % Change from Baseline in Gd-IgA -60 -56 -36 2 Week
Slide 17: Dose-dependent Reductions in Serum IgG, IgA, and IgM
Dose-dependent Reductions in Serum IgG, IgA, and IgM Through Week 24 n= Placebo 34 34 34 34 Atacicept 25 mg 16 16 16 15 Atacicept 75 mg 33 33 33 32 Atacicept 150 mg 33 33 32 32 34 34 34 34 16 16 16 15 33 33 33 32 33 33 32 31 34 34 34 34 16 16 15 14 33 33 28 23 33 32 22 19 IgG IgA IgM Mean ± SD % Cha
Slide 18: No Study Drug Discontinuation Due to IgG Levels on Atacicept
No Study Drug Discontinuation Due to IgG Levels on Atacicept No patient had study drug discontinuation, interruption, or sustained IgG <3 g/L (<300 mg/dL) through week 24 *Per ORIGIN protocol, if serum IgG was <300 mg/dL on two consecutive timepoints at least 28 days apart, the study drug was discon
Slide 19: Treatment-Emergent Adverse Events
Patients, n (%) Atacicept 25 mg n=16 Atacicept 75 mg n=33 Atacicept 150 mg n=33 Placebo n=34 TEAEs 11 (69) 24 (73) 25 (76) 27 (79) Study drug-related TEAEs1 6 (38) 16 (48) 18 (55) 14 (41) Serious TEAEs 1 (6) 1 (3) 0 3 (9) TEAEs leading to study drug discontinuation 0 0 1 (3)2 0 Deaths 0 0 0 0 Treatm
Slide 20: Infections Were Balanced Between Atacicept and Placebo
Infections Were Balanced Between Atacicept and Placebo Patients, n (%) Atacicept 25 mg n=16 Atacicept 75 mg n=33 Atacicept 150 mg n=33 Placebo n=34 Infections (all mild or moderate; no severe) 6 (38) 16 (48) 12 (36) 11 (32) Occurring in >1 patient COVID-191 4 (25) 9 (27) 8 (24) 6 (18) Upper respirat
Slide 21: Summary of Clinical Safety Data
Summary of Clinical Safety Data Atacicept was generally well tolerated in IgAN patients, with no reported deaths, low rate (2%) of serious AEs overall, and 1 patient (1%) discontinued atacicept due to AE Infections were balanced between atacicept and placebo No serious AEs in atacicept 150 mg group
Slide 22: Table of Contents
Table of Contents Opening Remarks Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall Fordyce, MD Jonathan Barrat
Slide 23: Summary of Positive Phase 2b Week 24 Results
Summary of Positive Phase 2b Week 24 Results Atacicept 150 mg dose selected for Phase 3 clinical trial, expected to initiate in 1H 2023 Atacicept met primary endpoint at week 24 Achieved statistical significance in 150 mg dose group with 33% reduction in proteinuria from baseline Trend towards furth
Slide 24: Atacicept Phase 2b Week 24 Data in Context
Atacicept Phase 2 Week 24 Data in Context Multinational, Randomized, Placebo-controlled Trials Drug Tarpeyo™ (approved) Atacicept Sibeprenlimab Sparsentan Dose Regimen & Administration 16 mg oral 9-month duration only 150 mg SC qwk selected for Ph 3 (1 x 1 mL injection) 2–8 mg/kg IV (Ph 2) 400 mg SC
Slide 25: Atacicept Has Well Characterized Safety Database vs APRIL-Only Approaches
No RCT safety data reported RCT safety data available Atacicept Has Well Characterized Safety Database vs APRIL-Only Approaches 1. Patients administered ≥1 dose of listed medication as of November 2022 review of published literature; 2. Based on published results involving safety per Levy et al Lupu
Slide 26: Atacicept Is Well Characterized Going Into Phase 3 vs APRIL-Only Approaches
Atacicept Is Well Characterized Going Into Phase 3 vs APRIL-Only Approaches This data is based on a cross-trial comparison and not a head-to-head clinical trial, such data may not be directly comparable due to differences in study protocols, conditions and patient populations. 1. Kooienga L, et al.
Slide 27: Phase 3 Pivotal Trial Design and Regulatory Update
Endpoints Primary efficacy: UPCR-24h at week 36 to support potential accelerated approval Key secondary: eGFR change up to week 104 Safety Initiation of Phase 3 Pivotal Trial Expected in 1H 2023 Atacicept Once Weekly SC Injection Formulation in Phase 3, Same as Phase 2b Week 0 Atacicept 150 mg qwk P
Slide 28: Potential Value Creation Over Next Months
Potential Value Creation Over Next 18 Months Program Indication Catalyst 2022 2023 2024+ Atacicept IgA Nephropathy Presented data on Gd-IgA1, anti-Gd-IgA1, and immune complexes from Phase 2a JANUS trial Completed enrollment in Phase 2b ORIGIN trial Present 24-week data from ORIGIN trial Present 36-w
Slide 29: Table of Contents
Table of Contents Opening Remarks Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall Fordyce, MD Jonathan Barrat
Slide 30: 8000 Marina Boulevard, Suite Brisbane, CA 94005 info@veratx.com +1 (650) 770-0077
8000 Marina Boulevard, Suite 120 Brisbane, CA 94005 info@veratx.com +1 (650) 770-0077