Pharming Group N.V. announced that the first patient has been dosed in a Phase II, proof-of-concept clinical trial of leniolisib for Common Variable Immunodeficiency (CVID) with immune dysregulation. This multi-center trial includes sites in the US, UK, and EU.
This marks the second Phase II clinical trial studying leniolisib for additional primary immunodeficiencies (PIDs), aiming to expand the therapeutic reach of the drug. CVID patients exhibit clinical phenotypes similar to Activated Phosphoinositide 3-kinase Delta Syndrome (APDS), for which leniolisib is already approved.
The global prevalence of CVID is estimated at approximately 39 per million, representing a significantly larger patient population than APDS. This trial underscores Pharming's strategy to leverage leniolisib's mechanism of action to address broader immune dysregulation disorders and grow the Joenja franchise.
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