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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

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
ALT decrease

MYR 202
Phase 2
Germany, Russia
NCT03546621

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)
NCT02888106

Study in Hepatitis D patients, on top of peg-Interferon (INF) or TDF vs INF
(90 patients)

Study in progress

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

Study in Hepatitis D patients
(150 patients)

Study in progress

MYR204
Phase 2
Russia, France, Moldova, Romania
NCT03852433

Study in Hepatitis D patients, on top of peg-Interferon (INF)
(175 patients)

Study in progress