HepaRegeniX reported that the first patient undergoing major liver resection for colorectal cancer liver metastases completed a 28-day treatment with darizmetinib in the second pilot part of its ongoing Phase 1b/2a study.
Darizmetinib has demonstrated a favorable safety profile to date, with no treatment-related serious adverse events reported, and the second Phase 1b pilot part is expected to enroll 10 patients and complete in the fourth quarter of 2026.
Following a planned safety review by an independent Data Safety Monitoring Board, the company anticipates seamlessly advancing darizmetinib into the randomized phase 2a portion in the same patient population; the seamless design was reviewed and authorized by the FDA, EMA, and the Israel Ministry of Health and by ethics committees and institutional review boards.
Enrolled patients receive 250 mg of darizmetinib orally twice daily for 28 days, and the study is being conducted at sites in the U.S., Germany, Spain, France and Israel.
The company claims darizmetinib is an oral inhibitor of MKK4 that in preclinical models selectively inhibits MKK4, stabilizes and protects hepatocytes and accelerates regenerative processes, and the company highlights potential applications including expanding surgical eligibility, preventing post transplant liver failure and treating acute and chronic liver diseases.
