Medpacto has begun clinical trials for its drug candidate 'MP2021' aimed at treating bone diseases and autoimmune disorders in Australia. The company aims to accelerate drug development by securing global clinical data.
On July 16, Medpacto announced that it has submitted the clinical trial plan for MP2021 to the Human Research Ethics Committee (HREC) in Australia.
MP2021 is a first-in-class drug candidate targeting the cell membrane protein 'TM4SF19,' which induces the formation of multinucleated osteoclasts that destroy bone. The clinical trials will focus on treating bone diseases such as rheumatoid arthritis, osteoporosis, and bone metastasis from cancer, as well as inflammatory autoimmune diseases.
Medpacto confirmed that it has observed the anti-inflammatory effects of MP2021 and its ability to improve bone and cartilage tissue damage during preclinical stages. The company also stated that it has ensured safety through toxicity assessments conducted in Europe.
Australia was selected as the site for the Phase 1 clinical trial to obtain clinical data that meets global standards and to recruit patients with rare bone-related diseases. Data from the Australian trials can be recognized by global regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Preclinical research results for MP2021 in treating psoriasis were published in the international journal Inflammation Research in April. Alongside this clinical trial, Medpacto is also pursuing the development of new modalities targeting TM4SF19. In addition to the existing fusion protein formulation, the company is collaborating with a Japanese pharmaceutical firm to conduct preclinical research on antibody-drug conjugate (ADC) candidates.
A Medpacto representative stated, "The application for the Phase 1 clinical trial in Australia signifies that our new pipeline has entered a full-fledged clinical stage. We aim to demonstrate our global market competitiveness through clinical trials and research on next-generation antibody therapies and ADC technology integration."
* This article has been translated by AI.
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