An open-label extension study evaluating the safety of zagociguat in participants with MELAS who completed TIS6463-203

Trial status: Authorised Vital sign measurements, ECG assessments, clinical laboratory tests, and C-SSRS responses at each scheduled timepoint, DEXA hip and lumbar spine BMD at each scheduled timepoint, Concentrations of CTX and P1NP at each scheduled timepoint, Incidence of SLE. Time to first SLE from Day 1, NMDAS scores at each scheduled timepoint, Concentrations of lactate, GDF-15, FGF-21, B2M, serum amyloid P component, TNFR-2, vWF, ICAM-1, NfL, and VCAM-1 at each scheduled timepoint, CGI-C overall MELAS scale score at each scheduled timepoint, eGFR and UACR at each scheduled timepoint, HbA1c level at each scheduled timepoint, Concentrations of troponin I, NT-proBNP, and creatine kinase (CK)-MB at each scheduled timepoint, Exploratory pharmacokinetics: Concentrations of zagociguat at each scheduled time point Incidence of treatment-emergent adverse events (TEAEs)

Vital sign measurements, ECG assessments, clinical laboratory tests, and C-SSRS responses at each scheduled timepoint, DEXA hip and lumbar spine BMD at each scheduled timepoint, Concentrations of CTX and P1NP at each scheduled timepoint, Incidence of SLE. Time to first SLE from Day 1, NMDAS scores at each scheduled timepoint, Concentrations of lactate, GDF-15, FGF-21, B2M, serum amyloid P component, TNFR-2, vWF, ICAM-1, NfL, and VCAM-1 at each scheduled timepoint, CGI-C overall MELAS scale score at each scheduled timepoint, eGFR and UACR at each scheduled timepoint, HbA1c level at each scheduled timepoint, Concentrations of troponin I, NT-proBNP, and creatine kinase (CK)-MB at each scheduled timepoint, Exploratory pharmacokinetics: Concentrations of zagociguat at each scheduled time point

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 14 participants