Vera Therapeutics (VERA) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Therapeutic approach and clinical rationale

• Atacicept targets BAFF and APRIL cytokines to modulate B-cell activity, aiming for disease modification in IgA nephropathy.

• IgA nephropathy chosen for its high unmet need and efficient regulatory pathway.

• Competing drugs do not target B cells; atacicept aims to address the root cause by reducing immune complex formation.

• Phase II-B ORIGIN 2 trial showed a two-thirds reduction in immune complexes and over 80% resolution of hematuria.

• GFR stability at 72 weeks suggests potential to prevent dialysis or transplant.

Clinical data and patient experience

• Statistically significant reduction in proteinuria at 24 and 36 weeks, with over 30% delta from placebo.

• Over 90% of patients in open-label extension continue self-injecting atacicept at 1.5 years.

• Atacicept is the only program with two-year phase II data and home self-administration.

• 75%-80% of patients had resolution of hematuria at 72 weeks.

• The drug is delivered via a prefilled syringe, similar in convenience to Ozempic.

Competitive landscape and trial design

• Atacicept is unique in dual BAFF/APRIL inhibition; preclinical data suggest dual targeting is superior to APRIL-only approaches.

• Phase III ORIGIN trial is fully enrolled, with results expected in H1 2025.

• Phase II included patients on SGLT2 inhibitors; about 15% were on these agents, and this is expected to increase.

• Study is powered at over 90% for primary endpoint (proteinuria at nine months) and GFR.

• Atacicept is positioned to launch commercially in 2026.