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Medivir receives regulatory approval from MHRA

Magnus Christensen

The company has received regulatory approval from the British Medicines & Healthcare products Regulatory Agency (MHRA) for its upcoming phase 1/2a combination study with the company’s leading candidate drug MIV-818 against liver cancer.

In the study, MIV-818 will be administered in two combinations, either with lenvatinib, a tyrosine kinase inhibitor or pembrolizumab, an anti-PD-1 check-point inhibitor.

About the trial

The planned trial will be an open-label, multi-center phase 1/2a study starting with a dose escalation part to establish the recommended phase 2 dose (RP2D). This is followed by the expansion study (phase 2a) with an initial evaluation of the safety and efficacy of the combination of MIV-818 with lenvatinib or pembrolizumab. The study will include patients with hepatocellular carcinoma (HCC) who have progressed on, or are intolerant of, first line standard therapy.

The study is planned to have two parallel dose-escalation streams. Once the RP2D has been established for the combinations, further cohorts of up to 30 patients with HCC will be enrolled in the phase 2a part of the study. The study will start in the UK and is planned later to include centers in Spain and South Korea. The first patient is expected to be enrolled in the second half of 2021.

”It is satisfactory that the preparations for the study are progressing according to plan. The MHRA approval is also an important seal of quality in the planning and design of the study,” says Magnus Christensen, Interim CEO of Medivir.

Photo of Magnus Christensen: Medivir