Medivir AB, a research-based pharmaceutical company, announced the successful completion of the pre-clinical safety studies for MIV-818 to enable the start of phase I clinical trials in 2018.
MIV-818 is Medivir’s proprietary liver-targeted nucleotide prodrug for the treatment of hepatocellular carcinoma (HCC) and other forms of liver cancer. It is the first development project to emerge from Medivir’s in-house drug discovery efforts in oncology.
With the successful completion of the pre-clinical safety studies on MIV-818, Medivir intends to make the necessary regulatory submissions during the first half of 2018, and to start the first clinical trials of MIV-818 during the second half of 2018.
“Patients with HCC and other forms of liver cancer are in urgent need of new treatment options. MIV-818 has been designed to deliver high levels of the active form of the drug to the liver after oral administration, while minimizing its exposure elsewhere in the body. This targeted approach to cancer chemotherapy has the potential to be an important new treatment for liver cancers, either alone or in combination with other therapeutic modalities”, said Richard Bethell, Medivir’s chief scientific officer.
“We are delighted that we now can enter clinical phase with MIV-818. It clearly underlines the strength of our in-house drug discovery platform and our prodrug expertise”, said Christine Lind, CEO of Medivir.
Liver cancer is the second highest cause of cancer-related death worldwide. Of the different forms of liver cancer, HCC is the most prevalent. It is classified as an orphan disease in the West, but is more common in Asia in general, and China in particular. MIV-818 has the potential to become the first liver-targeted, orally administered drug to address HCC and other forms of liver cancer.
Medivir AB (publ) is a research-based pharmaceutical company with a focus on oncology. The company has a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs.