Study of NM8074 in Adult C3 Glomerulopathy Patients

This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.

Inclusion Criteria:Patients ≥ 18 and ≤ 65 years at the time of consentDiagnosis of C3 Glomerulopathy as confirmed by C3 nephropathy in biopsy within 12 months prior to enrollmentReduced serum C3 levels (defined as less than 0.85 x lower limit of the central laboratory normal range) at ScreeningPatients with confirmed proteinuriaWilling and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit scheduleWomen of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping of investigational drugMales must agree to use contraceptives and refrain from donating sperm for the duration of the studyPatients must have documentation of previous vaccination or be willing to be vaccinated prior to dosing with NM8074. All patients will be vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations.Estimated glomerular filtration (eGFR) rate of ≤ 60 ml/min but ≥ 20 ml/minExclusion Criteria:Use of other investigational drugs at the time of enrollmentPatients with other renal diseases that would interfere with interpretation of the studyEstimated glomerular filtration rate of ≤ 20 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at ScreeningHas alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (xULN)Has a known history of meningococcal disease or N. meningitidisCurrently active systemic infection or suspicion of active bacterial, viral, or fungal infection that requires antibiotic, antifungal, antiparasitic, or antiviral mediationsTemperature > 38°C for more than two weeks prior to screeningHistory of renal organ transplantationPregnant, planning to become pregnant, or nursing female subjectsC3G patients currently under complement blocker treatmentsParticipation in any experimental small molecule or non-antibody therapy within 60 days prior to dosing on Day 1 (participation in observational studies and/or registry studies is permitted)