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MYR Pharmaceuticals — Treatment of HBV & HDV Infections

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Clinical Trials

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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
Phase 1a
Germany
Blank et al. (2016)

Safety study in healthy volunteers
(36 patients)

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
Phase 1
Germany
Blank et al. (2018)

Drug interaction (Bulevirtide and Tenofovir) study in healthy volunteers
(12 patients)

No interaction between Bulevirtide and Tenofovir detected

MYR 201
Phase 1b/2a
Russia
NCT02881008

Study in Hepatitis B patients with negative HBeAg 
(40 patients)

Bulevirtide showed a HBV DNA decline and ALT normalization in HBeAg negative chronic Hepatitis B patients 

MYR 201
(HDV substudy)
Phase 1b/2a
Russia
NCT02637999

Study in Hepatitis D patients wih HBeAg negative Hepatitis B
(16 patients plus comparison arm)

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
Phase 2
Germany, Russia
NCT03546621

Study in Hepatitis D patients  with Bulevirtide in combination  with tenofovir (TDF) and in comparison to TDF monotherapy
(120 patients)

Bulevirtide induced a statistically significant HDV RNA decline or negativation in all dose groups as well as a significant ALT decrease
in the 5 mg and 10 mg BLV arm.
Liver stiffness improvement was also shown for Bulevirtide treatment arms in contrast to TDF monotherapy.

MYR 203
Phase 2
Russia (ongoing)
NCT02888106

Study in Hepatitis D patients with Bulevirtide in combination with PEG-Interferon (PEG-INF) or TDF in comparison to PEG-INF monotherapy
(90 patients)

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
Phase 2
Russia, France, Moldova, Romania
NCT03852433

Study in Hepatitis D patients, with Bulevirtide in combination with  PEG-INF
(175 patients)

Study in progress

MYR301
Phase 3
Germany, Russia, Italy, Georgia, USA, Sweden
NCT03852719

Study in Hepatitis D patients  with Bulevirtide
(150 patients)

Study in progress