Brepocitinib Overview & RVT-3101 Update
RVT-3101 Was Well-Tolerated With No Safety Signals Identified in Ongoing
Phase 2b Study
Pbo
N = 45
Pooled
N = 200
Expected
Ph3 Dose
Participants with AEs
Participants with severe AES
Participants with serious AEs
56%
45%
53%
7%
2%
2%
7%
4%
3%
Participants discontinued study due to AEs
0%
0%
0%
Participants discontinued study drug due to AEs
4%
1%
1%
Participants with dose reduced or temporary discontinuation due to AEs
Deaths
0%
0%
0%
0%
0%
0%
Most Common AEs / AEs of Interest
Infection and Infestations
9%
10%
9%
Anemia
9%
4%
2%
Injection Site Reaction
COVID-19
2%
5%
5%
2%
1%
1%
•
•
•
The most common treatment emergent AEs were infections, anemia and injection site reactions, which were balanced across arms
There were no dose-related trends for AEs; severe and serious AEs were sporadic and generally considered not related to drug
No impact of immunogenicity on clinical efficacy or safety results
ADA rate of 46% and neutralizing antibody rate of 8% at expected Phase 3 dose
O
Immunogenicity results in-line with approved biologics*
Humira showed ADA rates of 32 - 46% and neutralizing antibody rates of 11 - 23% at week 241
-
Skyrizi showed ADA rates of 19% and neutralizing antibody rates of 8% at week 162
roivant
Reflects interim results from induction period of study (through week 14). If a given patient had more than one occurrence in the same event category, only the most severe occurrence was counted.
Patients were only counted once per treatment per event.
*Based on published data. No head-to-head studies were performed with approved biologics.
1. Hanauer et al 2021; Weinblatt et al 2017; Cohen et al 2019
2. Skyrizi (risankizumab) FDA Summary Basis of Approval
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