2026 EULAR | Phase IIb Trial Results of Orelabrutinib for SLE Presented at Prestigious International Academic Conference

InnoCare Pharma Limited (HKEX: 09969; SSE: 688428) today announced that the Phase IIb clinical trial results of orelabrutinib, its proprietary novel BTK inhibitor, for the treatment of systemic lupus erythematosus (SLE), have been selected for presentation at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress.

The results showed that the Phase IIb study of orelabrutinib in SLE met both its primary and secondary endpoints, making it the first BTK inhibitor globally to demonstrate efficacy in a Phase II clinical trial for SLE. Additionally, orelabrutinib significantly reduced disease activity and corticosteroid (GC) use, while showing promising trends in delaying SLE flare-ups and improving biomarkers. Orelabrutinib demonstrated a favorable safety and tolerability profile in SLE patients.

Poster Presentation

Orelabrutinib (a highly selective BTK inhibitor) for the Treatment of Systemic Lupus Erythematosus (SLE): Results from a Randomized, Double-Blind, Placebo-Controlled Phase IIb Study (Abstract No.: 2253)

This study aimed to evaluate the efficacy and safety of orelabrutinib in patients with moderate-to-severe SLE. A total of 187 patients were enrolled and randomly assigned in a 1:1:1 ratio to three groups: two orelabrutinib dose groups receiving 75 mg or 50 mg once daily orally, and one placebo group. The primary endpoint was the SLE Responder Index-4 (SRI-4) response rate at Week 48. Secondary endpoints included the SRI-6 response rate and the composite British Isles Lupus Assessment Group (BILAG2004)-based Composite Lupus Assessment (BICLA) response rate at Week 48. SRI-4 and BICLA are the most widely accepted primary endpoints in randomized controlled trials for SLE.

Results showed that, under stringent corticosteroid tapering requirements, the SRI-4 response rate at week 48 in the once-daily (QD) 75 mg orelabrutinib group was significantly higher than that in the placebo group (57.1% vs. 34.4%), with high statistical significance (P= 0.01 vs. placebo), meeting the primary endpoint. The SRI-6 and BICLA response rates in the 75 mg QD orelabrutinib group were also significantly higher than those in the placebo group, with statistical significance (P< 0.05), achieving the secondary endpoints.

It is important to note that the Phase IIb clinical trial strictly adhered to international standards in designing its corticosteroid tapering protocol. In the 75 mg QD group, 71.1% of patients reduced their corticosteroid dose to ≤7.5 mg, compared with 43.6% in the placebo group. Over 48 weeks, the 75 mg QD group achieved an average cumulative corticosteroid reduction of 301 mg more than the placebo group.

Orelabrutinib demonstrated a favorable safety and tolerability profile. The overall safety profile of treatment-emergent adverse events (TEAEs) during the trial was consistent with previous studies, and no new safety signals were identified.

Currently, the registrational Phase III clinical trial of orelabrutinib for the treatment of SLE is accelerating patient enrollment.

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