[E-Daily Reporter NA EUN-KYUNG ] MedPacto, Inc.(235980)announced on the 16th that it has submitted a Phase 1 clinical trial plan for MP2021, a drug candidate for the treatment of bone and autoimmune diseases, to the Australian Human Research Ethics Committee (HREC).

MP2021 is a first-in-class drug candidate that targets TM4SF19, a cell membrane protein involved in the formation of osteoclasts, which break down bone. MedPacto, Inc. is developing MP2021 for indications including bone diseases such as rheumatoid arthritis, osteoporosis, and bone metastases from cancer, as well as inflammatory autoimmune diseases.

MedPacto, Inc. explained that it has confirmed MP2021’s anti-inflammatory effects and its ability to improve damage to bone and cartilage tissue in preclinical studies, and has also established its safety through toxicity assessments conducted in Europe.

The company stated that it selected Australia as the first country for clinical trials, considering factors such as the availability of clinical data acceptable to global regulatory agencies and the ease of recruiting patients with rare bone diseases. It explained that clinical data obtained in Australia can be utilized by major regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and that Australia has a high prevalence of certain degenerative bone diseases, leading to active research in this area.

Alongside the development of MP2021, MedPacto, Inc. is also concurrently developing a new therapeutic targeting TM4SF19. In addition to its existing fusion protein formulations, the company is conducting preclinical research on next-generation antibody-drug conjugate (ADC) candidates in collaboration with a Japanese pharmaceutical company.

A company official stated, “This Phase 1 clinical trial application signifies that MP2021 has entered the full-scale clinical development stage,” adding, “Alongside clinical development, we will continue to develop next-generation antibody therapies and ADCs to secure global competitiveness.”

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