InnoCare Pharma’s orelabrutinib is progressing to a pivotal trial in systemic lupus erythematosus (SLE) after the drug displayed encouraging activity in a mid-stage trial.
During the Phase IIb study (NCT05688696), 187 patients with SLE were randomised to receive 48 weeks of treatment with either 75mg or 50mg orelabrutinib or placebo.
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Within the 48-week treatment window, the Bruton’s tyrosine kinase (BTK) inhibitor triggered a 57.1% improvement in patients’ SLE response index-4 (SRI-4) rates in the high dose cohort, meeting the trials primary endpoint.
This response rate was significantly higher than the SRI-4 score improvement of 34.4% observed in the placebo group.
Orelabrutinib also offered significant improvements to two other key measures of SLE severity and progression within the Phase IIb study, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) scores compared with placebo, meeting the study’s secondary endpoints.
The oral therapy’s impact on SLE disease activity and deterioration was dose-dependent, with the 75mg cohort experiencing a more profound impact than the 50mg group.
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By GlobalDataAlongside its promising efficacy profile, InnoCare stated that orelabrutinib was well tolerated across the patients enrolled onto the Phase IIb study. The company is yet to provide details on the drug’s safety profile, though it noted that it was “consistent with the mechanism of action of BTK inhibition”.
According to the Chinese biopharma, orelabrutinib is the first BTK inhibitor to exhibit efficacy in SLE at the Phase II stage, marking its potential as a first-in-class therapy for this indication.
To further assess the potential of orelabrutinib in SLE, InnoCare will progress the therapy to pivotal trials in the disease. The Chinese Center for Drug Evaluation (CDE) has already greenlit the upcoming study.
If orelabrutinib were to gain approval for SLE, it would become the fourth indication under the drug’s belt, with the pill having previously received approval from the Chinese National Medical Products Administration (NMPA) in various forms of lymphoma and leukaemia.
An annual sales and consensus forecast by GlobalData predicts that orelabrutinib will make $529m for InnoCare across its approved indications in 2031.
BTK inhibitors rise to prevalence in autoimmune space
BTK inhibitors have been available as a treatment option in the oncology space for years, with the first being Johnson & Johnson and AbbVie-owned Pharmacyclics’ Imbruvica (ibrutinib), which was approved by the US Food and Drug Administration (FDA) in 2013.
While BTK inhibitors are commonly used across the haematological cancer treatment paradigm, they have also attracted the attention of autoimmune researchers. This is primarily due to their capacity to inhibit the production of harmful autoantibodies associated with autoimmune disease pathology.
This has led to the development of BTK inhibitors for various forms of multiple sclerosis (MS), with Roche looking to gain approval for fenebrutinib in relapsing and primary progressive forms of the disease.
Sanofi is also seeking approval of its BTK inhibitor, tolebrutinib, in relapsing MS. Analysts at GlobalData, parent company of Clinical Trials Arena, forecast that it will become the first BTK inhibitor to obtain approval in this indication, despite a few bumps in the road throughout its development.
Novartis’ remibrutinib, which is already FDA approved for the treatment of chronic hives, is also in development for relapsing MS.
