[Edaily Reporter SONG YOUNG-DOO ] MedPacto, Inc.(235980)is adding a medium-dose patient group to the Phase 2 clinical trial of “Vactosertib,” which it is developing as a treatment for osteosarcoma. Since the medium-dose group showed relatively higher therapeutic efficacy in the Phase 1 trial, the company’s strategy is to compare the efficacy across different doses in Phase 2 to determine the optimal dose.
MedPacto, Inc. announced on the 7th that it had submitted an application to the Ministry of Food and Drug Safety for approval to amend its Investigational New Drug (IND) application to include a medium-dose patient group in the Phase 2 clinical trial of Vactosertib for osteosarcoma.
The current Phase 2 trial is being conducted with a high-dose group receiving 300 mg of Vactosertib twice daily. MedPacto, Inc. plans to add a medium-dose group receiving 200 mg twice daily. Adolescent patients will receive 150 mg twice daily.
The key objective of this amendment is to more specifically confirm the correlation between Baektoxetip’s dosage and therapeutic efficacy. MedPacto, Inc. explained that it had previously evaluated three dosages in the Phase 1 clinical trial and confirmed the best therapeutic efficacy in the medium-dose group.
However, in the Phase 2 clinical trial, development had focused primarily on the high-dose group, taking into account factors such as the patient observation period from the Phase 1 trial. The company subsequently decided to make this clinical trial modification after determining that it was necessary to compare the medium- and high-dose groups to verify the optimal dose.
In particular, the addition of this new dose group aligns with the U.S. Food and Drug Administration’s (FDA) policy on optimizing anticancer drug dosing. In its 2024 guidelines on clinical dosing for anticancer drugs, the FDA recommends comparing and evaluating two or more doses, including the maximum tolerated dose (MTD).
The Phase 2 clinical trial of Bactosetip for osteosarcoma is currently underway simultaneously in South Korea and the United States. Following its application to amend the IND in South Korea, MedPacto, Inc. plans to submit a request for the same clinical amendment to the FDA shortly.
The company expects that the addition of a moderate-dose patient group will have a positive impact on patient recruitment. It explains that as the trial expands from the existing single high-dose patient group to multiple dose groups, patient recruitment—which had been proceeding somewhat slowly—may gain momentum.
A MedPacto, Inc. official stated, “We are continuously reviewing and refining the optimal dosage based on data accumulated from this osteosarcoma trial and the existing Bactosetip trial,” adding, “We will do our utmost to secure the best possible data in the Phase 2 trial, just as we did in Phase 1.”
Bactosetip is a TGF-β signaling inhibitor currently under development by MedPacto, Inc. MedPacto, Inc. previously confirmed an objective response rate (ORR) of 36.4%, including complete remission (CR), in a Phase 1 clinical trial involving 11 osteosarcoma patients.
Osteosarcoma is a rare malignant tumor that occurs in bones and cartilage. Although combination therapy with chemotherapy is currently the primary treatment, it has limitations in terms of therapeutic efficacy and survival rates, making osteosarcoma a disease with high unmet medical need for new treatment options.
