Medivir said it is targeting accelerated approval of its lead candidate fostroxacitabine bralpamide (fostrox) once it completes a Phase IIb trial in hepatocellular carcinoma (HCC).
CEO Jens Lindberg told the Clinical Trials Arena that the Swedish company is looking to initiate the Phase IIb trial by the end of the year once getting approval from the US Food and Drug Administration (FDA).
The trial will investigate Medivir’s lead candidate fostrox as a second-line combination therapy with Eisai’s Lenvima (lenvatinib).
The trial will involve around 210 patients, who will be randomised a 2:1 ratio of treatment to placebo.
Patients in the treatment arm will receive 30mg fostrox taken orally for five days in a 21-day cycle, alongside the recommended dose of Lenvima.
The trial will take place at around 30 sites worldwide, including the UK, Spain, US, and South Korea, among other countries.
The primary endpoint for the trial is set to be progression free survival (PFS) as opposed to overall response rate (ORR).
If the trial is successful, Lindberg said the company will use the data to apply to the FDA for accelerated approval.
Fostrox acts by inhibiting the activity of DNA polymerase, an enzyme responsible for DNA replication by gathering nucleotides. By inhibiting the DNA replication, an aberrant cell cycle gets under control and ameliorates the condition.
The company previously reported topline results from its Phase I/IIa trial (NCT03781934) which was positive and demonstrated a good safety and tolerability profile for the combination therapy.
HCC landscape
HCC is the most common type of liver cancer, accounting for 70% to 90% of liver cancer cases. According to GlobalData, the global HCC market is expected to grow from $1.4bn in 2019 to $5.5bn in 2029.
Systemic anti-tumour therapy, including molecular targeted therapy, chemotherapy, and immune checkpoint inhibitors combined with anti-angiogenic monoclonal antibodies, are the main treatments for advanced HCC.
GlobalData is the parent company of Clinical Trials Arena.
