InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)
Shots:
- Innocare has reported P-IIb trial data assessing orelabrutinib (50 or 75mg, QD, PO) vs PBO in 187 SLE pts for 48wks. & NMPA approval to initiate P-III trial
- Trial met its 1EP, with 75mg achieving a significantly higher SRI-4 response at Wk. 48 vs PBO (57.1% vs 34.4%) & showing dose-dependent efficacy over 50mg; 75mg also met 2EPs with higher SRI-6 & BICLA responses at 48wks.
- Also, Orelabrutinib 75mg delivered a 35% higher SRI-4 response in pts with BILAG ≥1A or ≥2B, & a 43% higher SRI-4 response in those with BILAG ≥1A or ≥2B plus SLEDAI-2K ≥4
Ref: Innocare | Image: Innocare | Press Release
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