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MedPacto laboratory.

MedPacto announced on the 19th that it received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) protocol amendment to add a medium-dose patient cohort in the Phase 2 clinical trial of Vactosertib, a treatment for osteosarcoma, a rare bone cancer.

The clinical trial is currently underway simultaneously in South Korea and the U.S. Earlier in South Korea, the company received approval in September from the Ministry of Food and Drug Safety for an identical clinical trial modification.

The approved amendment adds a 200 mg BID (twice daily) medium-dose cohort (150 mg BID for adolescents) alongside the currently ongoing 300 mg BID high-dose cohort.

Through this cohort addition, MedPacto expects to precisely evaluate the correlation between drug dosage and therapeutic response in the ongoing Phase 2 osteosarcoma trial and secure optimal efficacy data.

In the Phase 1 osteosarcoma trial, the company recorded an objective response rate (ORR) of 36.4%, more than three times higher than conventional therapies, including complete remission (CR). In the ongoing Phase 2 trial, the company has reportedly secured data meeting essential requirements under the protocol.

Osteosarcoma is a rare malignant tumor that primarily occurs in children, adolescents, and young adults. Conventional treatments have limitations in improving efficacy and survival rates, leading to expectations of robust global market demand and growth potential upon successful drug development.

A MedPacto official said, "Given that relatively superior therapeutic responses were observed in the medium-dose cohort in the Phase 1 trial, this protocol amendment approval will allow us to verify the optimal dosage."

                                                                                                      Moon Jeong-woo