Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Mar 17
- 2 min read
16/03/2026
Spyre Therapeutics announced results from the Phase 2 rheumatoid arthritis sub-study (Ref)
Spyre Therapeutics announced the completion of recruitment for the rheumatoid arthritis (RA) sub-study of the Phase 2, SKYWAY/ NCT07148414 basket trial
Week 12 topline data from the RA sub-study were expected in Q3 2026
Recruitment for the psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) sub-studies of SKYWAY remained on track, and week 16 topline readouts were expected in Q4 2026
The SKYLINE platform trial in ulcerative colitis (UC) continued to enroll ahead of schedule, and part A readouts were expected to begin in Q2 2026
InnoCare Pharma announced that ICP-538 had been approved for clinical trials in China and had completed dosing of the first subject (Ref)
InnoCare pharma announced that ICP-538 (selective molecular degrader of VAV1), the first VAV1 molecular glue degrader in China and the second globally to enter clinical trials, had completed dosing for its first patient
It was intended for the development of treatments for various refractory autoimmune diseases such as inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE), and multiple sclerosis (MS)
Preclinical studies showed that ICP-538 deeply degrades VAV1, significantly reducing cytokines linked to immune-mediated diseases without affecting other proteins
At the time, no VAV1-targeted drugs were approved on the market globally
Lilly announced Phase 3 results of lebrikizumab in pediatric patients with moderate-to-severe AD (Ref)
Eli Lilly and Company announced positive topline results from its Phase 3 ADorable-1/ NCT05559359 study, which evaluated EBGLYSS (lebrikizumab; anti IL-13) for the treatment of pediatric patients with moderate-to-severe atopic dermatitis (AD)
The trial met its primary and key secondary endpoints:
Primary endpoints: 63% of patients achieved meaningful skin improvement (EASI-75) and 44% achieved clear or almost clear skin (IGA 0/1) at Week 16
key secondary endpoints: 39% of patients achieved a high bar of near-complete skin clearance (EASI-90) and 35% achieved significant itch relief (Pruritus NRS ≥4-point improvement)
The safety and tolerability profile of EBGLYSS was consistent with adult and adolescent studies, with no injection site pain reported
Lilly planned to submit these data to US and global regulators for a potential label update
Additional results from ADorable-1 and ADorable-2, a 52-week extension study of patients enrolled in ADorable-1, were to be disclosed later that year
Sun Pharma announced US FDA had accepted for review the sBLA for tildrakizumab for the treatment of adults with active PsA (Ref)
Sun Pharma announced that the US FDA had accepted for review the supplemental Biologics License Application (sBLA) for ILUMYA (tildrakizumab; anti-IL-23) for the treatment of adult patients with active psoriatic arthritis
The sBLA was supported by the Phase 3, INSPIRE-1/ NCT04314544 and INSPIRE-2/ NCT04314531 studies, which evaluated tildrakizumab in PsA
The FDA regulatory action date for this sBLA was expected by October 29, 2026
