MedPacto Receives Approval for Phase 1 and 2 Clinical Trial Plans of Bactosertib for Osteosarcoma Treatment

For Patients with Recurrent, Refractory, and Progressive Osteosarcoma

[Asia Economy Reporter Myung-Hwan Lee] MedPacto announced on the 16th that it has received approval for an Investigational New Drug (IND) application from the Ministry of Food and Drug Safety for single-agent therapy of Bexotertinib in patients with recurrent or progressive osteosarcoma.

This clinical trial is a Phase 1/2 study of single-agent Bexotertinib therapy in 54 adolescent and adult patients aged 14 years or older with recurrent, refractory, or progressive osteosarcoma.

MedPacto Headquarters Exterior [Photo by MedPacto]

MedPacto plans to evaluate the safety, tolerability, pharmacokinetics, and anticancer efficacy of single-agent Bexotertinib in the clinical trial and, based on interim analysis results, will assess safety and efficacy in a larger patient population. A MedPacto representative stated, "We initiated the domestic clinical trial with the intention of providing clinical opportunities to osteosarcoma patients in Korea who currently have no suitable treatment options," adding, "The trial will confirm the safety of single-agent Bexotertinib in osteosarcoma patients."

In August of last year, MedPacto received approval from the U.S. Food and Drug Administration (FDA) for Phase 1/2 clinical trials of single-agent Bexotertinib in osteosarcoma patients. Single-agent Bexotertinib has also been designated by the FDA as a drug for rare pediatric diseases and as a fast-track development item.

Osteosarcoma is a malignant tumor that arises from bone or bone-related cartilage and other osseous tissues, accounting for approximately 0.2% of all malignant tumors. Osteosarcoma primarily occurs in younger age groups, with about 60% of cases developing during childhood or adolescence. It is known that 25-50% of osteosarcoma patients experience metastasis to the lungs, which often leads to death.