Vera Therapeutics : Effect of Atacicept on Renal Function in SLE Patients

Effect of Atacicept on Renal Function in SLE Patients

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David Isenberg1, Celia J.F. Lin2, Amy Kao3, Aida Aydemir 3, Caroline Gordon4

Institutions:

1. Centre for Rheumatology, University College London
2. Vera Therapeutics, Inc., Brisbane, CA, United States
3. EMD Serono Research & Development Institute, Inc (a business of Merck KGaA)
4. Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, United Kingdom

Disclosures

• David Isenberg: Consultant for Vera Tx, Servier, AstraZeneca, Idorsia, EMD Serono, and Amgen. His honoraria are passed onto a local arthritis charity
• Celia J.F. Lin: Employee of Vera Therapeutics
• Amy Kao: Own stocks and employee of EMD Serono Research & Development Institute, Inc (a business of Merck KGaA)
• Aida Aydemir: Employee of EMD Serono Research & Development Institute, Inc (a business of Merck KGaA)
• Caroline Gordon: Speakers bureau for UCB, Consultant for the Center for Disease Control and Prevention, Amgen, Astra-Zeneca, AbbVie, EMD Serono, MGP, Sanofi, and UCB. Educational grant from UCB to Sandwell and West Birmingham Hospitals NHS Trust that supported previous research work unrelated to any specific drug (last payment July 2019)

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Atacicept is a Dual Inhibitor (BLyS and APRIL) of Plasma Cells and B Cells

Key Considerations

• Fully humanized fusion protein, subcutaneously administered weekly

• Dual blockade by TACI-Ig shown to be more potent than blocking BLyS alone or APRIL alone1 and has benefit of targeting long-lived plasma cells2, in addition to B cells, thus reducing autoantibody production3

1 Haselmayer P et al. Eur J Immunol 2017;00:1-11.2Hiepe F et al. Nat Rev Rheumatol 2011;3:170-178.3Gordon et al. 2017

3 Arthritis & Rheumatology 69(1): 122-130.

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Atacicept demonstrated clinical efficacy in SLE, with a delayed time to first flare in treated patients compared to placebo

APRIL-SLE Trial Design

Multicenter, double-blind,placebo-controlled, randomized, dose-ascending study

Trial	Patients (n=461) with active SLE1
Population

• Subcutaneous injection

Dosing • Randomized to atacicept 75 or 150 mg or placebo

• Twice-weeklydosing for four weeks, then weekly dosing for 48 weeks

1 Defined as y category A or B manifestations (excluding a single B score in haematology) on the BILAG index. 2 Defined as BILAG flare score A or B. Source: Isenberg, D, Gordon C, Licu D, et al. Ann Rheum Dis. 2015 Nov; 74(11):2006-15.

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Primary endpoint not met for atacicept 75 mg; however, ad hoc analysis showed treatment benefit of atacicept 150 mg in prevention of flare

Proportion of Subjects Who Experienced a Flare in the 52-Week Treatment Period by Analysis Population in APRIL-SLE

Population	Statistic	Placebo	Atacicept 75 mg	Atacicept 150 mg
mITT	n	154	157	144
	Presence of a flare, n (%)	82 (53.25)	90 (57.32)	52 (36. 11)
	Odds Ratioa		1.160	0.490
	[95% Cl]		[0.74, 1.82]	[0.31, 0.78]
	p-value		0.518	0.003
PC	n	81	84	81
	Presence of a flare, n (%)	49 (60.49)	49 (58.33)	35 (43.21)
	Odds Ratioa		0.893	0.491
	[95% CI]		[0.48, 1.67]	[0.26, 0.92]
	p-value		0.724	0.027

Source: Study 27646 CSR Tables 15.2.1.1a, Table 15.2.1.1b, Table 15.2.1.1c, Table 15.2.1.1d

Cl= confidence interval; mITT = modified Intent-to-Treat (all randomized and treated subjects); PC= potential

completer (all randomized and treated subjects who were randomized at least 52 weeks before discontinuation of the atacicept 150 mg group, and who therefore had the opportunity to complete the 52-week treatment period before this treatment group was discontinued).

1. Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at Screening. Race and disease severity were not statistically significant in the model.

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