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
NCT03832114 (CLNP023X2202)
C3 glomerulopathy (C3G)
Phase 2
27
Cohort A: Ratio to Baseline of UPCR to Week 12 derived from 24hr urine collection
Cohort B: Change from Baseline in C3 Deposit Score (based on
immunofluorescence microscopy) at Week 12
Increasing doses of LNP023 up to 200mg bid:
Cohort A: Native kidney patients
Cohort B: Kidney transplanted patients
Patients with C3 glomerulopathy
H1-2021 (interim actual)
Actual: Interim analysis data from Cohort-A presented at American Society of
Nephrology (ASN 2020).
Planned: Note not to be communicated externally until accepted.
1) Planned abstract at ERA-EDTA, Q3 2021
2) Planned abstract at ASN, Q4 2021
NCT03896152 (CLNP023X2204)
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
13
Reduction of PNH associated hemolysis, based on percentage of patients with 60%
reduction in LDH or LDH below upper limit of normal up to 12 weeks of treatment.
approximately 2 year Treatment with low LNP023 dose
approximately 2 year Treatment with higher LNP023 dose
Patients with PNH, showing signs of active hemolysis, not treated with any other
complement inhibitor less than 3 months prior to study start Day 1
Primary: Q2-2020 (actual)
Extension: 2022
-Jang JH, et al. Presented at Korean Society of Hematology International
Conference and 62nd Annual Meeting (ICKSH 2021)
-Presented as an oral presentation (encore) at the European Haematology
Association (EHA 2021) congress
-Planned manuscript submission in Q3 2021
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