Motys (PTP-001) / Bioventus - LARVOL DELTA

Doron Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for MOTYS for Treatment of Symptoms Associated With Osteoarthritis (ACCESSWIRE) - "Doron Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to MOTYS, its lead placental tissue-derived biologic in clinical development for the treatment of symptoms associated with knee osteoarthritis (OA). In addition to RMAT, MOTYS was also granted Fast Track designation (FTD) by FDA....Doron's RMAT and Fast Track designation requests were supported by the body of preclinical and clinical evidence available on MOTYS, with specific emphasis on the clinical findings from its Phase 2 dose-finding study of 215 patients, which identified durable, dose-dependent effects of MOTYS on pain mitigation and improved functional outcomes (presented at the Osteoarthritis Research Society International (OARSI) World Congress 2024)."

FDA event • Osteoarthritis

Safety And Efficacy Results From A Phase 1 Clinical Trial Of Ptp-001, An Injectable Placental Tissue Biologic For Knee Osteoarthritis (OARSI 2023) - P1 | "Preclinical studies have demonstrated that PTP-001 contains a number of highly relevant growth and cell-regulatory factors, and exhibits a multifactorial mechanism of action which can be beneficial in abrogating relevant molecular pathways contributing to joint inflammation/pain and tissue damage. We herein describe results of the initial Phase 1 clinical trial of PTP-001 in patients with knee OA (NCT04632966)."

Clinical • P1 data • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Composition and Bioactivity of a Placental Tissue Particulate (PTP-001) Indicate Greater Potential than Platelet-Rich Plasma for the Treatment of Osteoarthritis. (PubMed, Cartilage) - "These findings support evidence of a potent, multifactorial mechanism of action for a consistently manufactured biologic (PTP-001), which may be of greater therapeutic benefit in comparison with more heterogeneous preparations of PRP which may be generated at the time of treatment."

Journal • Immunology • Inflammation • Oncology • Osteoarthritis • Pain • Rheumatology • MMP13 • TNFA

Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=210 | Active, not recruiting | Sponsor: Bioventus LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

QUANTITATIVE COMPOSITIONAL AND BIOACTIVITY ANALYSES OF A NOVEL PLACENTAL TISSUE BIOLOGIC (PTP-001) COMPARED WITH PLATELET RICH PLASMA (PRP) (OARSI 2022) - "PTP-001 represents a novel placental tissue particulate which is in development as a biologic for the treatment of pain and impaired function in patients suffering from OA of the knee. In the current study, we performed quantitative analyses of growth factor content, and assessed bioactivity in cell-based assays to compare PTP-001 with PRP prepared using two commonly-employed methodologies."

Immunology • Osteoarthritis • Pain • Rheumatology

Safety Study of PTP-001 for Treating Knee Osteoarthritis (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: Bioventus LLC; Recruiting ➔ Active, not recruiting; Trial completion date: Aug 2022 ➔ Dec 2022; Trial primary completion date: May 2022 ➔ Sep 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Phase 2 Dose-finding Trial of PTP-001 (MOTYS) for Knee Osteoarthritis (clinicaltrials.gov) - P2; N=210; Recruiting; Sponsor: Bioventus LLC

Clinical • New P2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

A novel placental tissue biologic, PTP-001, inhibits inflammatory and catabolic responses in vitro and prevents pain and cartilage degeneration in a rat model of osteoarthritis. (PubMed, Osteoarthritis Cartilage) - "PTP-001 represents a promising biologic treatment for osteoarthritis, with a multi-modal mechanism of action that may contribute to symptom management and disease modification."

Journal • Preclinical • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology • MMP13

Safety Study of PTP-001 for Treating Knee Osteoarthritis (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Bioventus LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

Bioventus Reports First Patients Enrolled in Phase 1 Clinical Trial of MOTYS (PTP-001) for the Treatment of Knee OA (GlobeNewswire) - "Bioventus...reported that the first patients have been enrolled and dosed in its Phase 1 open-label, dose-escalation study of MOTYS (PTP-001)....The study is evaluating the safety and efficacy of MOTYS (PTP-001) to treat osteoarthritis (OA) of the knee. Researchers are enrolling 20 patients with each patient receiving a single injection of PTP-001."

Trial status • Osteoarthritis • Pain

Bioventus Receives Authorization to Proceed Under Investigational New Drug Application for Clinical Trial of Placental Tissue Particulate (PTP-001) for the Treatment of Knee OA (Businesswire) - "Bioventus...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....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."

Enrollment status • IND • Osteoarthritis • Pain

Safety Study of PTP-001 for Treating Knee Osteoarthritis (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Bioventus LLC

Clinical • New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology