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Pharming Group has announced positive results from the Phase II/III study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).
Commercial-stage biopharmaceutical company, Pharming Group, has announced positive results from the Phase II/III study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Currently, treatment of APDS is limited to supportive therapies, with no therapy approved for the treatment of the disease.
The study of leniolisib, which is a small-molecule PI3Kδ inhibitor, comprised two sequential parts and was sponsored by Novartis—the company that discovered and developed the drug before licensing it to Pharming in 2019. The primary efficacy results of the study have demonstrated that leniolisib is clinically effective when compared with placebo at reducing lymph node size and correcting immunodeficiency.
“These study results demonstrate the tremendous power of collaborative clinical research with scientists, clinicians, and patients working together with the pharmaceutical industry,” said Virgil Dalm, principal investigator, Erasmus University Medical Center Rotterdam, the Netherlands, in a Feb. 2, 2022 press release. “[APDS] patients have limited treatment options including symptomatic therapies, such as antibiotics, antivirals and immunoglobulin replacement therapy (IgRT) … I look forward to working with Pharming to bring leniolisib to APDS patients and studying it further in younger children, as well as other patient populations that may benefit from this precisely targeted therapy.”
Full study results will be presented at upcoming medical conferences and are also due to be published in a peer-review journal. Regulatory submissions for leniolisib as a treatment for APDS are expected to commence in the second quarter of 2022.