Myrcludex B has been tested in a total of six clinical trials (four completed and two ongoing) that include 239 human subjects – healthy volunteers and Hepatitis B and D patients.
| Study | Description | Results |
|---|---|---|
| MYR 101 Phase 1a Germany |
Safety study in healthy volunteers (36 patients) |
Excellent safety and tolerability |
| MYR 102 Phase 1 Germany |
Drug interaction study in healthy volunteers (12 patients) |
No interaction detected |
| MYR 201 Phase 1b/2a Russia NCT02881008 |
Study in Hepatitis B patients (40 patients) |
HBV DNA decline ALT normalization |
| MYR 201 (HDV substudy) Phase 1b/2a Russia NCT02637999 |
Study in Hepatitis D patients (16 patients plus comparison arm) |
HDV RNA decline or negativation |
| MYR 202 Phase 2 Germany, Russia |
Study in Hepatitis D patients, on top of tenofovir (TDF) vs TDF (120 patients) |
HDV RNA decline or negativation in all dose groups ALT decrease Liver stiffness improvement |
| MYR 203 Phase 2 Russia (ongoing) |
Study in Hepatitis D patients, on top of peg-Interferon (INF) vs INF | Study in progress |