DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a leader in Solutions For Innovative Healing, received authorization to proceed under its investigational new drug (IND) application from the US Food and Drug Administration (FDA), allowing it to proceed to clinical trials of PTP-001. PTP-001 (commercial trade name MOTYS™) is a placental tissue particulate comprised of amnion, chorion and umbilical cord from full-term, healthy births and is provided sterile in micronized form.
Bioventus plans to evaluate the safety and efficacy of PTP-001 to treat osteoarthritis of the knee through an open-label, dose-escalation study. The study is expected to enroll 20 patients, 40-80 years of age and test two doses (low and high dose) of PTP-001 in two unique cohorts of 10 patients each. Each patient will receive 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 delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations For Active Healing from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com and follow the company on LinkedIn and Twitter.
Bioventus and the Bioventus logo are registered trademarks and MOTYS is a trademark of Bioventus LLC.