(RTTNews) - InnoCare Pharma Limited (INCPF), a biopharmaceutical company, on Friday announced promising Phase 2b results for Orelabrutinib in treating systemic lupus erythematosus (SLE). The data was presented at the 2026 Congress of the European Alliance of Associations for Rheumatology (EULAR).
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that effects the skin, joints, kidneys, and associated organ systems in affected individuals. The disease is often treated with corticosteroids, which can cause significant cumulative toxicity.
Orelabrutinib is a novel (Bruton-Kinase) BTK- inhibitor that was developed as an immunotherapy for cancers and autoimmune diseases.
The randomized, double-blind, placebo-controlled Phase 2b trial was conducted on 187 patients with moderate to severe SLE. The primary endpoint was set at a SLE response index-4 (SRI-4) response rate, as observed at Week 48. Secondary endpoints measured improvements on the SRI-4, BILAG 2004, and BICLA scales, which are globalized indices used to measure SLE responses.
Patients treated with a daily 75 mg daily dose of Orelabrutinib showed higher SRI-6 and BICLA response rates when compared to the placebo group. 71.2% of patients showed a reduction of dependence on corticosteroids, while the dependence in the placebo group decreased by 43.6%.
The company plans to initiate a Phase 3 trial based on the strength of Phase 2b results and has accelerated enrollment for the same.
INCPF is currently trading at $1.55.
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