[Edaily Reporter KIM SAE-MI ] MedPacto, Inc.(235980)announced on the 6th that it has received approval for the Phase 1 clinical trial plan (IND) for “MP2021,” a drug candidate for the treatment of bone and autoimmune diseases, from the Australian Human Research Ethics Committee (HREC).

This clinical trial is designed to evaluate the safety of MP2021 in healthy adults. MedPacto, Inc. plans to develop MP2021 as a treatment for bone diseases and inflammatory autoimmune diseases, including rheumatoid arthritis, osteoporosis, and bone metastases from cancer.

MP2021 is a new drug candidate that targets “TM4SF19,” a cell membrane protein involved in the formation of multinucleated osteoclasts, which break down bone. MedPacto, Inc. is developing MP2021 as a first-in-class drug.

Previously, in July, MedPacto, Inc. submitted an application for a Phase 1 clinical trial of MP2021 in Australia. The company selected Australia as the initial clinical trial site to rapidly secure clinical data that meets global standards and to facilitate patient recruitment for future clinical trials targeting rare bone-related diseases.

According to the company, the clinical data obtained in Australia can be used as supporting documentation for subsequent clinical development submissions to major regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Australia has a relatively high incidence of certain degenerative bone diseases, leading to active research in this area.

A MedPacto, Inc. official stated, “With this approval, MedPacto, Inc. now has its second clinical-stage drug candidate, following ‘Baekto-Sotip.’”

Meanwhile, MP2021 was selected as a project by the Korea Drug Development Fund (KDDF) in 2023 and is receiving government research funding.