On June 5, 2022 InnoCare Pharma (HKEX: 09969), a leading biotech company, reported that Professor Zhanguo Li, the leading PI, has presented latest data of BTK inhibitor orelabrutinib for the treatment of Systemic Lupus Erythematosus (SLE) at the just-concluded EULAR 2022 European Congress of Rheumatology (Press release, InnoCare Pharma, JUN 5, 2022, View Source [SID1234615577]). The abstract was selected as late-breaking oral presentation.
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Late-breaking Oral Presentation:
Orelabrutinib, an irreversible inhibitor of Bruton’s tyrosine kinase (BTK), for the treatment of SLE: results of a randomized, double-blind, placebo-controlled, phase Ib/IIa dose-finding study
Abstract Number: LB0005
The study is aimed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), preliminary efficacy and biomarkers of orelabrutinib in patients with mild to moderate SLE who received standard of care therapy.
The study randomized 60 patients with 55 patients who completed 12-week treatment. Baseline disease characteristics were generally balanced across treatment groups. Orelabrutinib was generally well tolerated in patients with SLE.
The plasma exposure of orelabrutinib (AUC and Cmax) was proportionally increased with doses. Nearly complete BTK occupancy was achieved at all dose levels, and the occupancy lasted for 24 hours.
In all evaluable patients, the SLE Response Index (SRI)-4 response rates at week 12 were 50.0%(7/14), 61.5%(8/13) and 64.3%(9/14) in patients treated with orelabrutinib at 50mg, 80mg and 100mg respectively, compared with 35.7%(5/14) in patients treated with placebo, which indicated a trend of dose-dependent improvement.
Among the small cohort of subgroup of patients with SLEDAI-2K≥8 at screening, SRI-4 response occurred in 70%(7/10), 70%(7/10) and 66.7%(6/9) of patients who received orelabrutinib at 50mg, 80mg and 100mg, respectively, compared with 30%(3/10) who received placebo.
A biological signal of reduced proteinuria, anti-dsDNA and IgG, total B cells and increased complements C4 were also observed following orelabrutinib administration.
Professor Zhanguo Li said, "Orelabrutinib was generally well tolerated in patients with SLE. We are encouraged by the preliminary results suggesting trends in efficacy and supporting further studies in longer-term trials and larger cohorts of SLE patients."
More information can be found at EULAR official website.
About Orelabrutinib
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
On Dec. 25 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.
In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.
Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).
In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.