MedPacto Adds Medium-Dose Group to Phase 2 Clinical Trial of Osteosarcoma Drug 'Vactosertib'

[Financial News] MedPacto is adding a medium-dose patient group to the Phase 2 clinical trial of 'Vactosertib,' which is being developed as a treatment for osteosarcoma.
MedPacto announced on the 15th that it has received approval from the Ministry of Food and Drug Safety for an amendment to its Investigational New Drug (IND) application to add a 200mg BID (twice daily) medium-dose patient group to the Phase 2 clinical trial of Vactosertib for osteosarcoma. Adolescent patients will receive 150mg BID.
In the previous Phase 2 clinical trial, the study was conducted on a high-dose group of patients receiving 300mg BID. With this change, a medium-dose group has been added, making it possible to compare therapeutic efficacy and safety according to the administered dosage.
As MedPacto confirmed relatively superior therapeutic effects in the medium-dose patient group in the Phase 1 clinical trial, it plans to verify the optimal dose of Vactosertib through this Phase 2 clinical trial.
Clinical trials of Vactosertib for osteosarcoma are being conducted simultaneously in Korea and the United States. MedPacto plans to apply to the U.S. Food and Drug Administration (FDA) for approval of the amendment to the clinical trial plan in the future.
In the previously conducted Phase 1 clinical trial for osteosarcoma, an objective response rate (ORR) of 36.4%, including complete remission (CR), was recorded among 11 patients. The company explained that this was more than three times higher than existing treatments.
Osteosarcoma is a rare malignant tumor that occurs in the bones and cartilage. Although combination chemotherapy is currently used as the standard treatment, there are limitations to improving treatment efficacy and survival rates, creating demand for new treatments in this field.
A MedPacto official said, "We confirmed the most superior therapeutic effect in the medium-dose patient group in the Phase 1 clinical trial. We expect that this approval of the amendment will allow us to verify the optimal dosage while also accelerating patient recruitment."

[email protected] Jeong Sang-hee Reporter