Medivir selects global CRO partner for upcoming phase 2b study in HCC with fostrox + Lenvima and initiates study feasibility

Rhea-AI Summary

Medivir AB (NASDAQ: MVIR) has announced the selection of a global CRO partner for its upcoming phase 2b study focused on treating second-line hepatocellular carcinoma (HCC) with fostroxacitabine bralpamide (fostrox) and Lenvima. The study aims to compare the efficacy of fostrox + Lenvima versus Lenvima alone. This global, randomized study follows a supportive Type C interaction with the FDA and will be conducted across the US, EU, and Asia. The initiative intends to identify optimal sites and investigators by early 2025, leveraging high interest from HCC experts. The selected CRO, known for its expertise in oncology and HCC studies, will help ensure the study's successful execution.

Positive

• Medivir has partnered with a global CRO known for expertise in oncology and HCC.
• The phase 2b study design received supportive feedback from the FDA.
• High interest from HCC experts for study participation.
• Global study encompassing US, EU, and Asia enhances recruitment potential.

Negative

• Potential delays if study feasibility and site selection are not completed as planned.
• Risk of unsuccessful recruitment impacting study timelines and outcomes.

STOCKHOLM, June 19, 2024 /PRNewswire/ -- Medivir AB (NASDAQ: MVIR) (STOCKHOLM: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that it has selected a global CRO partner for the planned phase 2b study evaluating fostroxacitabine bralpamide (fostrox) + Lenvima® vs Lenvima alone in second line HCC.

In the next phase of development, Medivir is planning for a global, randomized phase 2b study aligned with its recent supportive Type C interaction with the FDA. The objective is to evaluate the combination of fostrox + Lenvima in second line advanced HCC with the aim of becoming the first, approved treatment alternative after current first line treatment.

The study is planned to enroll patients broadly in the US, EU and Asia, building on countries and sites participating in currently ongoing phase 1b/2a, which will ensure that recruitment requirements for a potential accelerated or conditional approval are fulfilled. A key next step is to initiate study feasibility to identify optimal sites and investigators to enable study start in early 2025. Already now, we have received high level of interest from experts in HCC regarding potential participation in the study.

-          "With the selection of a CRO partner, following our recent Type C meeting with the FDA, we are confidently moving forward with the enhanced phase 2b study design. It has been a thorough process to select the best possible partner to ensure optimal execution of the upcoming study across all geographies. The selected CRO partner has a global footprint, with a strong track record in performing oncology studies in general and HCC studies in particular. We are now moving forward with next steps, which include performing the feasibility, operational and regulatory study preparations as well as finalisation of the study protocol to open an IND in the USA.", says Malene Jensen, VP Clinical Development at Medivir.

For additional information, please contact
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: magnus.christensen@medivir.com

About fostrox

Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing harmful effects on normal livercells. This is achieved by coupling a chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in advanced HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. The unmet medical need is especially high in second line where there are no approved treatments post first line standard of care. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent¹⁾. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

About Medivir

Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.

1) Rumgay et al.,European Journal of Cancer 2022 vol.161, 108-118.

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SOURCE Medivir

FAQ

What is the focus of Medivir's upcoming phase 2b study?

The study focuses on evaluating fostroxacitabine bralpamide (fostrox) + Lenvima versus Lenvima alone in second-line hepatocellular carcinoma (HCC).

When is Medivir planning to start the phase 2b study?

Medivir aims to start the phase 2b study in early 2025.

Which regions will be involved in Medivir's phase 2b study?

The study will be conducted globally, including the US, EU, and Asia.

What is Medivir's stock symbol?

Medivir's stock symbol is MVIR.

Why is Medivir conducting a phase 2b study with fostrox and Lenvima?

Medivir aims to evaluate the combination of fostrox and Lenvima as a second-line treatment for advanced HCC, potentially becoming the first approved alternative after current first-line treatments.