InnoCare Pharma announces phase IIb study of orelabrutinib met primary endpoint

InnoCare Pharma (INCPF) announced that the phase IIb clinical study of novel BTK inhibitor orelabrutinib has met the primary endpoint in patients with systemic lupus erythematosus. InnoCare has also received approval from the Center for Drug Evaluation, CDE, to conduct a phase III registrational clinical trial. Orelabrutinib demonstrated outstanding efficacy and well-tolerated safety profile in patients with SLE who had received 48 weeks of treatment in the phase IIb study. A total of 187 patients were enrolled and randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg QD, and placebo.