HepaRegeniX has announced that the first patient undergoing major liver resection due to liver metastases from colorectal cancer has completed 28 days of treatment with darizmetinib in the second pilot part of its ongoing phase 1b/2a study.
The company said darizmetinib has shown a favorable safety profile to date, with no treatment‑related serious adverse events reported. The second phase 1b pilot part is expected to enrol 10 patients and finish in the fourth quarter of 2026.
Following a safety review by an independent Data Safety Monitoring Board, HepaRegeniX plans to advance darizmetinib seamlessly into the randomized phase 2a portion of the study in the same patient population. The combined phase 1b/2a design has been reviewed and authorised by the FDA, EMA and the Israel Ministry of Health, as well as ethics committees and Institutional Review Boards.
Linda Greenbaum, Chief Medical Officer at HepaRegeniX, said: “Darizmetinib is progressing rapidly through the clinic, with the first of 10 patients having completed treatment in the second part of the phase 1b study, and a favorable safety profile observed to date.”
She added: “The progress of the study reflects our streamlined trial design and the readiness of our clinical sites. The identical patient population planned for the phase 2a allows us to build on the clinical experience generated in phase 1b and maintain development momentum. While the study remains ongoing, we are encouraged by these early observations and by the potential of darizmetinib to address a significant unmet need for patients undergoing major liver resection.”
Prof Niv Pencovich, Principal Investigator at Sheba Medical Center, explained: “Major liver resection is an important part of standard of care for patients with liver metastases, but postoperative recovery of liver function remains a critical challenge. Completing treatment of the first patient undergoing major liver resection in this part of the study marks a significant milestone.”
He added: “We are proud to contribute to the clinical evaluation of darizmetinib in this setting and look forward to the findings from the program.”
The ongoing phase 1b builds on completion of the first part of the study in patients after minor liver resection, where darizmetinib showed a favorable safety profile. Patients receive 250mg twice daily for 28 days. The study is being conducted across sites in the U.S., Germany, Spain, France and Israel, all of which are expected to support the phase 2a portion.
