InnoCare Pharma announced the enrollment of the first patient in the Phase III registrational clinical trial of orelabrutinib for the treatment of systemic lupus erythematosus

InnoCare Pharma (SSE code: 688428; HKEX code: 09969) today announced that the company’s self-developed novel BTK inhibitor orelabrutinib has completed the enrollment of the first patient in the registrational Phase III clinical study for the treatment of systemic lupus erythematosus (SLE).

This is a randomized, double-blind, placebo-controlled, multicenter Phase III study assessing the efficacy and safety of orelabrutinib in SLE patients, with the primary endpoint being the SLE Responder Index-4 (SRI-4) response rate at Week 52 of treatment.

The Phase IIb study of orelabrutinib for SLE met its primary endpoint, becoming the world's first BTK inhibitor to demonstrate efficacy in a Phase II clinical trial for the treatment of SLE. Under stringent corticosteroid tapering requirements, at Week 48, the once-daily (QD) 75 mg orelabrutinib dose group showed a significantly higher SLE Responder Index-4 (SRI-4) response rate compared to the placebo group (57.1% vs. 34.4%), with highly statistically significant results (p<0.05), achieving the primary endpoint. In the subgroup of patients with baseline disease activity BILAG ≥1A or ≥2B and clinical SLEDAI-2K score ≥4, the SRI-4 response rate for the 75 mg QD orelabrutinib dose group was 68%, representing a substantial increase of 43% over the placebo group. More critically, the Phase IIb clinical trial strictly followed international standards in designing the corticosteroid tapering regimen, with 71.1% of patients in the 75 mg group reducing their corticosteroid dosage to ≤7.5 mg, compared to 43.6% in the placebo group.

Dr. Jisong Cui, Co-founder, Chairman, and CEO of InnoCare Pharma, said, 'Systemic lupus erythematosus presents a significant unmet clinical need. Patients often require long-term, even lifelong medication, greatly impacting their quality of life. We will accelerate the advancement of Phase III clinical development to bring better treatment options to SLE patients.'

SLE is a systemic autoimmune disease that often leads to damage across multiple organs, especially the kidneys, musculoskeletal system, nervous system, skin, hematological system, and respiratory system—nearly all systems may be affected. According to Frost & Sullivan analysis, there are approximately 8 million people worldwide living with SLE. The '2020 China Systemic Lupus Erythematosus Development Report' indicates that there are about 1 million SLE patients in China, ranking first globally in total numbers and second in incidence. The most common SLE patients are young and middle-aged women, requiring years or even decades of long-term management, presenting a massive unmet treatment demand.

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