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.