Bulevirtide has been tested in a total of eight clinical trials (five completed and three ongoing) that include more than 269 human subjects – healthy volunteers and Hepatitis B and D patients.
Study |
Description |
Results |
---|---|---|
MYR 101 |
Safety study in healthy volunteers |
Excellent safety and tolerability in all doses ranging from 300 ng to 20 mg i.v.and 800 µg to 10 mg s.c. |
MYR 102 |
Drug interaction (Bulevirtide and Tenofovir) study in healthy volunteers |
No interaction between Bulevirtide and Tenofovir detected |
MYR 201 |
Study in Hepatitis B patients with negative HBeAg |
Bulevirtide showed a HBV DNA decline and ALT normalization in HBeAg negative chronic Hepatitis B patients |
MYR 201 |
Study in Hepatitis D patients wih HBeAg negative Hepatitis B |
Bulevirtide induced HDV RNA decline or negativation and ALT decrease in patients with HBeAg negative chronic hepatitis B co-infected with hepatitis delta |
MYR 202 |
Study in Hepatitis D patients with Bulevirtide in combination with tenofovir (TDF) and in comparison to TDF monotherapy |
Bulevirtide induced a statistically significant HDV RNA decline or negativation in all dose groups as well as a significant ALT decrease |
MYR 203 |
Study in Hepatitis D patients with Bulevirtide in combination with PEG-Interferon (PEG-INF) or TDF in comparison to PEG-INF monotherapy |
Bulevirtide monotherapy led to a linear HDV RNA decline and ALT improvement. The HDV RNA response was more effective with around 80% HDV RNA negativation in combination with PEG-IFN |
MYR204 |
Study in Hepatitis D patients, with Bulevirtide in combination with PEG-INF |
Study in progress |
MYR301 |
Study in Hepatitis D patients with Bulevirtide |
Study in progress |