Bioventus received authorization to proceed under its Investigational New Drug application from FDA, and will proceed to clinical trials evaluating MOTYS™ (PTP-001), a placental tissue particulate, to treat osteoarthritis of the knee.
The study will enroll 20 patients, 40 to 80 years old, testing low and high doses in a single injection of PTP-001.
“This submission and open IND for PTP-001, the first for Bioventus, is a monumental milestone in the history of our young company. We are proud of our submission team and are ready to begin enrolling patients and administering PTP-001 in Phase 1 of our study,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus.
“This study will assess clinical safety of two doses of PTP-001, both at or higher than those often utilized today by physicians. Our goals are to begin to clarify the potential dose for PTP-001 and to determine whether PTP-001 could fulfill an unmet need for physicians and their patients with knee osteoarthritis,” she added.
Bioventus received authorization to proceed under its Investigational New Drug application from FDA, and will proceed to clinical trials evaluating MOTYS™ (PTP-001), a placental tissue particulate, to treat osteoarthritis of the knee.
The study will enroll 20 patients, 40 to 80 years old, testing low and high doses in a single injection of...
Bioventus received authorization to proceed under its Investigational New Drug application from FDA, and will proceed to clinical trials evaluating MOTYS™ (PTP-001), a placental tissue particulate, to treat osteoarthritis of the knee.
The study will enroll 20 patients, 40 to 80 years old, testing low and high doses in a single injection of PTP-001.
“This submission and open IND for PTP-001, the first for Bioventus, is a monumental milestone in the history of our young company. We are proud of our submission team and are ready to begin enrolling patients and administering PTP-001 in Phase 1 of our study,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus.
“This study will assess clinical safety of two doses of PTP-001, both at or higher than those often utilized today by physicians. Our goals are to begin to clarify the potential dose for PTP-001 and to determine whether PTP-001 could fulfill an unmet need for physicians and their patients with knee osteoarthritis,” she added.
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