MedPacto wins approval for Australian Phase 1 trial of MP2021, a new drug candidate for bone and autoimmune diseases

[Financial News] MedPacto is set to begin a Phase 1 clinical trial of MP2021, a drug candidate being developed to treat bone and autoimmune diseases.
MedPacto said on the 6th that Australia's Human Research Ethics Committee (HREC) had approved the Phase 1 clinical trial plan for MP2021. With this approval, MedPacto has secured a second drug candidate in clinical development, following Vactosertib.
MP2021 is a first-in-class drug candidate that targets TM4SF19, a cell membrane protein that induces the formation of multinucleated osteoclasts that destroy bone.
The Phase 1 trial will assess the safety of MP2021 in healthy adults. MedPacto plans to develop it to treat bone diseases, including rheumatoid arthritis, osteoporosis, and bone metastasis by cancer cells, as well as inflammatory autoimmune diseases.
MedPacto previously said that, when it applied for the clinical trial in July, it planned to conduct the trial in Australia to obtain early clinical data meeting global standards and recruit patients with rare bone-related diseases.
Clinical data obtained in Australia can be used by global regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Australia is also known to have a high incidence of some deforming bone diseases, with research into them being active.
MP2021 was selected as a project under the Korea Drug Development Fund (KDDF) in 2023 and is receiving government research funding.

[email protected] Jeong Sang-hee Reporter