Digmbio's PARP1 Inhibitor selected by KDDF to support Phase 1 clinical trial

Phase 1 clinical development funding for HRD mutant cancer is being provided and safety and MTD to be confirmed.. The first patient dose is expected to begin this month.

Digmbio announced on the 14th that it was selected as a company to receive support for Phase 1 clinical trials in the 2nd National New Drug Development Project (KDDF) in 2024.

Accordingly, Digmbio plans to support for clinical research and development expenses for the second-generation PARP1 selective inhibitor ‘DM5167’ to evaluate the drug’s safety and tolerability and confirm the maximum tolerated dose (MTD) with the clinical research fund.

DM5167 is a second-generation PARP (poly ADP-ribose polymerase) inhibitor that selectively inhibits PARP1.  The company expects that it will overcome the blood toxicity that was a limitation of the existing first-generation PARP inhibitors and, in particular, have blood-to-brain penetration, so it will be effective for patients with BRCA metastatic brain tumors who were difficult to access with existing treatments.

The government-funded Phase 1 clinical trial will be divided into two parts. Part 1 will primarily evaluate the drug's safety and tolerability in patients with HRD mutations, including BRCA mutations. Part 2 will expand the evaluation of DM5167's efficacy and safety by adding patients with HRD-mutant metastatic brain tumors.

The clinical trial will be conducted at Seoul National University Hospital, Seoul National University Bundang Hospital, Severance Hospital, and Samsung Medical Center in Seoul, and the first patient administration is scheduled for October.

Kim Jeong-min, CEO of Digmbio, said, “Through this phase 1 clinical trial, we will confirm the innovative therapeutic potential of DM5167 and play a leading role in the global market.” He added, “DM5167’s PARP1 selectivity and high safety allow for combination therapy with various anticancer drugs, which will allow for expansion of indications.”