Vera Therapeutics, Inc. · NASDAQ:VERA
Vera Therapeutics — Technical Presentation (October 2024)
14 slides from Vera Therapeutics's technical presentation, Oct 26, 2024
Slide 1: Long-term Results From the ORIGIN Phase 2b Study of Atacicept for the Treatment of IgAN
Long-term Results From the ORIGIN Phase 2b Study of Atacicept for the Treatment of IgAN Jonathan Barratt,1 Sean Barbour,2 Robert Brenner,3 Kerry Cooper,3 Xuelian Wei,3 Necmi Eren,4 Jürgen Floege,5 Vivekanand Jha,6 Sung Gyun Kim,7 Bart Maes,8 Richard Phoon,9 Harmeet Singh,10 Vladimir Tesar,11 Richard
Slide 2: Disclosures
Disclosures Vera Therapeutics, Alnylam Pharmaceuticals, Argenx, Astellas Pharma, Consulting and Speaker Fees BioCryst Pharmaceuticals, Calliditas Therapeutics, Chinook Therapeutics, Dimerix, Galapagos, Novartis, Omeros, Travere Therapeutics, Visterra Argenx, Calliditas Therapeutics, Chinook Therapeu
Slide 3: IgAN is a B-cell mediated disease with kidney pathology
IgAN is a B-cell mediated disease with kidney pathology B Cell Activation Formation of Circulating Immune Complexes Immune Complex Deposition Leading to Glomerulonephritis and Kidney Damage Autoantigen (Gd-IgA1) BAFF TACI B cell Glomerulus APRIL Autoantibody (anti-Gd-IgA1) 1 2 3 4 5 BAFF and APRIL a
Slide 4: Atacicept is a dual inhibitor of BAFF and APRIL
Atacicept is a dual inhibitor of BAFF and APRIL Rational drug design: native TACI receptor fused to Fc — fully humanized soluble fusion protein BAFF APRIL Atacicept BAFF APRIL t1/2=35 days1 Kd Kd 1.45 nM2 0.672 nM2 TACI receptor TACI receptor B cell Fc domain B cell of IgG1 Fc = fragment crystalliza
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 of atacicept self-administered at home via weekly 1-mL SC injection Double-Blind Treatment OLE Placebo n=30 Atacicept 25 mg QW n=15 Atacicept 150 mg QW Atacicept 75 mg QW n=30 Atacicept 150 mg
Slide 6: Demographics and baseline characteristics
Demographics and baseline characteristics1 Atacicept treated participants2 n=113 Age, median (range), y 37 (18, 67) Male sex, n (%) 67 (59) Race, n (%) White 59 (52) Asian 51 (45) Native Hawaiian or Other Pacific Islander 1 (1) Other/not reported 2 (2) eGFR, mean ± SD, mL/min/1.73 m2 62 ± 28 UPCR by
Slide 7: Participant disposition through 96 weeks
Participant disposition through 96 weeks 232 screened 116 failed screening Randomized 116 randomized and treated double-blind treatment period 82 atacicept1 34 placebo1 2 discontinued treatment2 3 discontinued treatment3 80 (98%) Completed week 36 and entered OLE 31 (91%) OLE period 111 entered OLE
Slide 8: 36-week results consistent with disease modifying IgAN profile
ORIGIN Phase 2b 36-week results consistent with disease modifying IgAN profile Placebo Atacicept 150 mg 15 Reduction in Gd-IgA1 0 Resolution of hematuria -5% Mean ± SE % Change from BL in % Participants (95% CI)2 0 -20 Mean Change from BL -15 -7% in Gd-IgA11 -40 -30 -60 -45 p<0.001 p<0.001 -60 -80 -
Slide 9: 96-week long-term results consistent with disease modifying IgAN profile
ORIGIN Phase 2b long-term results consistent with disease modifying IgAN profile Data from first dose of atacicept through 96 weeks 0 Reduction in Gd-IgA1 0 Resolution of hematuria Mean ± SE % Change from BL in % Participants (95% CI)2 -15 -20 Mean Change from BL in Gd-IgA11 -30 -40 -45 -60 -60 -80
Slide 10: Atacicept eGFR slope profile consistent with general population without kidney disease
Atacicept treated participants have an eGFR slope profile consistent with the general population without kidney disease 4 Slope, mL/min/y Change from Baseline in 0 eGFR, mL/min/1.73m2 Atacicept ~ -0.6 General population ~ -1 -4 estimate1 IgAN natural history -8 including supportive CKD therapy2 ~ -6
Slide 11: Atacicept well tolerated through 96 weeks: OLE AE profile consistent with randomized period
Atacicept well tolerated through 96 weeks: OLE AE profile consistent with randomized period Double-Blind Open-Label Extension Baseline to Week 36 Week 36 to 961 Placebo All Atacicept Atacicept 150 mg Participants, n (%) n=34 n=82 n=111 TEAEs 28 (82) 60 (73) 85 (77) Infections and infestations 11 (32
Slide 12: Conclusions
Conclusions • Participants treated with atacicept for 96 weeks demonstrated sustained and substantial reductions in Gd-IgA1, hematuria and UPCR with long-term stabilization of eGFR • The cumulative favorable safety profile remains consistent with that observed during the randomized 36 weeks of ORIGI
Slide 13: Acknowledgments
Acknowledgments Thank you to all our ORIGIN Phase 2b study volunteers and their families and the ORIGIN investigators, study staff, and collaborators Australia R Francis, V Levidiotis, E Pedagogos, R Phoon, J Ryan Belgium A Bouquegneau, B Maes, M Speeckaert Canada S Barbour Czech Republic I Rychlik,
Slide 14: Long-term Results From an Open-label Extension Study of Atacicept for IgA Nephropathy
Scan to view manuscript Long-term Results From an Open-label Extension Study of Atacicept for the Treatment of IgA Nephropathy Jonathan Barratt,1 Sean J. Barbour,2 Robert M. Brenner,3 Kerry Cooper,3 Xuelian Wei,3 Necmi Eren,4 Jürgen Floege,5 Vivekanand Jha,6-8 Sung Gyun Kim,9 Bart Maes,10 Richard Ph
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