- Pharming Group (PHARM, Financial) to present results from Phase III clinical trials on leniolisib for pediatric APDS at the 2025 Clinical Immunology Society Meeting.
- Six poster presentations scheduled, including studies on immune dysregulation and demographic characteristics in APDS patients.
- Regulatory approval for leniolisib in pediatric patients with APDS remains pending.
Pharming Group N.V. (PHARM) has announced its participation in the 2025 Annual Meeting of the Clinical Immunology Society (CIS), set to occur from May 1-4 in Philadelphia, USA. The event will feature multiple presentations focusing on the company's ongoing research on leniolisib, specifically targeting pediatric patients aged 4-11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).
The company will present six posters covering various aspects of leniolisib's clinical applications and related studies. The presentation topics include the Phase 3 study outcomes of leniolisib in pediatric APDS patients, the impact of immune dysregulation in common variable immunodeficiency, and patient demographics from the APDS-CHOIR registry. These research initiatives offer promising insights, although the safety and efficacy of leniolisib in this pediatric cohort have not yet received regulatory approval.
In addition to APDS, leniolisib's effects on autoimmune lymphoproliferative syndrome (ALPS-FAS) are being explored preclinically, though those findings are yet to be translated into clinical results. Furthermore, Pharming is actively pursuing regulatory approval in multiple regions and is continuing its research into leniolisib's potential applications in primary immunodeficiencies with immune dysregulation.