On the 19th, MedPacto, Inc. announced that it had received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) amendment to add a medium-dose patient group to the Phase 2 clinical trial of Vactosertib for osteosarcoma.
With this amendment, a 200 mg twice daily (BID) moderate-dose group will be added to the currently ongoing 300 mg BID high-dose group. For pediatric patients, the moderate dose is 150 mg BID.
This clinical trial is being conducted simultaneously in South Korea and the United States. In South Korea, the company received approval for the same clinical trial amendment from the Ministry of Food and Drug Safety last month.
MedPacto, Inc. views the addition of this dose group as an opportunity to examine the relationship between dosage and therapeutic response more precisely and to secure optimal efficacy data.
A MedPacto, Inc. official stated, “Given that a generally excellent treatment response was observed in the medium-dose patient group in the Phase 1 clinical trial, we expect to be able to validate the optimal dose through this approval of the clinical trial amendment.”
In its Phase 1 clinical trial for osteosarcoma, MedPacto, Inc. recorded an objective response rate (ORR) of 36.4%—more than three times higher than existing treatments—including complete remission (CR). The company explained that it has also secured data meeting the essential protocol requirements in its ongoing Phase 2 clinical trial.
Osteosarcoma is a rare malignant tumor that originates in the bones and primarily affects children, adolescents, and young adults. Since existing treatments have limitations in terms of efficacy and survival rates, the market is projected to expand significantly worldwide once a new treatment is developed.
