REG-Pharming announces positive Phase II topline data for leniolisib in PIDs with immune dysregulation accepted as late-breaking abstract at ESID 2026
Pharming reported positive Phase II topline data for leniolisib in genetically defined primary immunodeficiencies (PIDs) with PI3Kδ-driven immune dysregulation, with the late-breaking abstract accepted for presentation at ESID 2026 in the Netherlands, October 14-17. The single-arm, open-label, intra-patient dose-escalation study enrolled 13 subjects. Leniolisib was generally well tolerated with no new safety signals, and showed clinical improvement in lymphoproliferative disease, including a mean 26.4% spleen volume reduction and reductions in index lesion size. Nine of the 13 patients also had common variable immunodeficiency (CVID).
Key figures
- Drug Name
- leniolisib
- Phase Of Trial
- Phase II
- Trial design
- single-arm, open-label, intra-patient dose-escalation
- Subjects enrolled
- 13
- Cvid subset patients
- 9
- Cvid topline expected
- Q4 2026
- Esid presentation dates
- October 14-17, 2026, Netherlands
- Mean spleen volume reduction pct
- 26.4
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