Isofol Medical has received approval to start the pivotal Phase III AGENT clinical study to treat patients with metastatic colorectal cancer (mCRC) at Japanese sites.

The latest move comes following the completion of Japan’s Pharmaceutical and Medical Devices Agency (PMDA) review of the company’s clinical trial notification (CTN), which is equivalent to a US investigational new drug application (IND).

The randomised, controlled, multi-centre study will evaluate the efficacy and safety of arfolitixorin and [6R]-5,10-methylene-tetrahydrofolic acid (MTHF) compared to leucovorin, both used in combination with 5-FU, oxaliplatin, and bevacizumab.

As per the feedback received from the PMDA, the company expects that the data from the ongoing AGENT trial can be classified as the basis to submit the application for the approval of manufacturing and marketing of the drug in Japan.

The recently received CTN in Japan, along with the combination of the existing IND for arfolitixor in the US and Clinical Trial Application (CTA) in Europe, drives potential towards receiving the global approval of arfolitixor.

Isofol Medical CEO Anders Rabbe said: “Japan represents a very important potential market for Isofol and one we see as a top priority as we advance the development of arfolitixorin in mCRC patients globally.

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“We look forward to launching the pivotal Phase III AGENT clinical study in Japan in early 2020 and continuing our discussions with the PMDA and potential partners in Japan as we map out a path to market for our drug candidate.”

The primary endpoint of the AGENT (ISO-CC-007) trial is overall response rate (ORR), while the key secondary endpoints are progression-free survival (PFS) and duration of response (DOR).

Isofol expects to receive top-line data from the study in 2021.

Patient recruitment is currently underway in North America and Europe and will be expanded to include patients from Japan.

Isofol Medical chief medical officer Roger Tell said: “With the CTN now in effect, the next steps include obtaining Institutional Review Board approval and finalising agreements with each of the participating clinical sites.

“In the near term, Isofol will be focusing on these activities, with support from our Japanese CRO, CMIC Shift Zero, in preparation for the start of enrolment.”