Q2 2021 Results - Reimagining Medicine
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
References
Financial performance
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Oncology
Ophthalmology
Respiratory
Sandoz Biopharmaceuticals
Global Health
Abbreviations
LNP023 - Factor B inhibition of the complement alternative
pathway
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
Target Patients
Read-out Milesstone(s)
Publication
NCT04558918 APPLY-PNH (CLNP023C12302)
Paroxysmal nocturnal haemoglobinuria
Phase 3
91
Percentage of participants achieving a sustained increase in hemoglobin levels of ≥
2 g/dL in the absence of red blood cell transfusions
Percentage of participants achieving sustained hemoglobin levels ≥12 g/dL in the
absence of red blood cell transfusions
Arm 1: Drug: LNP023, taken orally b.i.d. dosage supplied: 200 mg dosage form:
hard gelatin capsule Route of Administration: Oral
Arm 2: Drug: Eculizumab, administered as intravenous infusion every 2 weeks as
per the stable regimen, the maintenance dose is a fixed dose. Dosage supplied:
300 mg/30mL Dosage form: Concentrate solution for infusion
Drug: Ravulizumab, administered as intravenous infusion every 8 weeks, the
maintenance dose is based on body weight. Dosage Supplied: 300 mg/30mL
Dosage form: Concentrate solution for infusion
Adult patients with PNH and residual anemia, despite treatment with an intravenous
Anti-C5 antibody
Primary 2022
TBD
NCT04578834 APPLAUSE-IgAN (CLNP023A2301)
IgA nephropathy
Phase 3
450
Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine
collection) at 9 months
Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated over
24 months
Arm 1 LNP023 200mg BID
Arm 2 - Placebo BID
Primary IgA Nephropathy patients
2023
Perkovic et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1: Study
Design
Wong et al. 2021, Nephrology Dialysis Transplantation, Vol. 36, Suppl. 1:
IPTACOPAN (LNP023): A NOVEL ORAL COMPLEMENT
ALTERNATIVE PATHWAY FACTOR B INHIBITOR SAFELY AND EFFECTIVELY
STABILISES EGFR IN C3 GLOMERULOPATHY
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