Sam Brusco, Associate Editor03.15.21
Bioventus Inc. reported the first patients were enrolled and dosed in its Phase 1 open-label, dose-escalation study of MOTYS (PTP-001) with Dr. Shailesh Patel, M.D. at Coastal Carolina Research Center, South Carolina. MOTYS is a placental tissue particulate comprised of amnion, chorion, and umbilical cord tissue from full-term, healthy births and is provided sterile in micronized form.
The study is evaluating MOTYS (PTP-001)’s safety and efficacy to treat knee osteoarthritis (OA). Researchers will enroll 20 patients, with each patient receiving a single injection of PTP-001. Patients will be followed up to evaluate local and systemic reactions to the drug candidate, as well as to assess in pain and mobility improvements over the course of the study.
Bioventus is one of several market leaders in HA therapy used to treat OA knee pain with the largest portfolio of HA products including DUROLANE, GELSYN-3, and SUPARTZ FX and believes products like PTP-001 fill a need and provide more options in an OA market growing due to the aging population.
“The announcement that the first patients have been enrolled and dosed in this Phase 1 clinical study of PTP-001 is an important milestone for Bioventus especially given the challenging environment many clinical research centers are navigating due to COVID-19,” Alessandra Pavesio, senior vice president and chief science officer of Bioventus told the press. “This trial represents the first of multiple studies that Bioventus intends to conduct to demonstrate the safety and efficacy of our innovative biologic drug candidate designed to treat a prevalent, growing and debilitating condition like knee osteoarthritis, which significantly affects the quality of life of more than 14 million Americans.”
The study is evaluating MOTYS (PTP-001)’s safety and efficacy to treat knee osteoarthritis (OA). Researchers will enroll 20 patients, with each patient receiving a single injection of PTP-001. Patients will be followed up to evaluate local and systemic reactions to the drug candidate, as well as to assess in pain and mobility improvements over the course of the study.
Bioventus is one of several market leaders in HA therapy used to treat OA knee pain with the largest portfolio of HA products including DUROLANE, GELSYN-3, and SUPARTZ FX and believes products like PTP-001 fill a need and provide more options in an OA market growing due to the aging population.
“The announcement that the first patients have been enrolled and dosed in this Phase 1 clinical study of PTP-001 is an important milestone for Bioventus especially given the challenging environment many clinical research centers are navigating due to COVID-19,” Alessandra Pavesio, senior vice president and chief science officer of Bioventus told the press. “This trial represents the first of multiple studies that Bioventus intends to conduct to demonstrate the safety and efficacy of our innovative biologic drug candidate designed to treat a prevalent, growing and debilitating condition like knee osteoarthritis, which significantly affects the quality of life of more than 14 million Americans.”