Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, recently declared the publication of positive results from a pilot study demonstrating the safety and promising efficacy of the nSTRIDE® Autologous Protein Solution (APS) Kit for the treatment of knee osteoarthritis (OA). In the trial, known as PROGRESS II, investigators prepared APS by using Zimmer Biomet’s nSTRIDE APS Kit, which concentrates anti-inflammatory cytokines and growth factors from a sample of the patient’s blood, for delivery via a single intra-articular injection into the knee joint. The results, which appeared in The American Journal of Sports Medicine1, show noteworthy improvement in the percentage change from baseline in pain scores measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in addition to comparable safety to saline.
OA, the most common type of arthritis, is a progressive disease of the joints. Often referred to as “wear and tear” arthritis, OA occurs when the top layer of cartilage, the slippery tissue that covers the ends of bones in a joint and assists absorb the shock of movement, breaks down and wears away. The bones of the cartilage then rub together, causing pain, swelling, and loss of motion in that joint. Eventually, the joint may lose its regular shape and develop bone spurs around its edges.
“Inflammation is a critical factor in the pain and cartilage breakdown associated with knee osteoarthritis, and research has established that APS derived from the patient’s whole blood contains a host of powerful anti-inflammatory and anabolic proteins,” said Elizaveta Kon, MD, Associate Professor, Humanitas University, Milan, Italy, and lead investigator of the PROGRESS II trial. “After nearly a decade of preclinical and clinical research into the use of autologous anti-inflammatory cytokines and growth factors to treat osteoarthritis pain, we were happy to demonstrate that APS, prepared with the nSTRIDE APS Kit, may be a promising, safe and viable new treatment for patients living with osteoarthritis of the knee.”
The PROGRESS II trial was a prospective, randomized, double-blind, saline-controlled pilot study that enrolled 46 patients with unilateral, mild-to-moderate, symptomatic knee OA pain from the four trial sites across Europe. Patients were randomized to receive either a single injection of APS prepared by the nSTRIDE APS Kit (n=31), or a single saline injection (n=15). Patient-stated outcomes and adverse events were estimated at two weeks, and at one, three, six and 12 months post-injection. Clinical effectiveness was measured using the Visual Analog Scale (VAS), the WOMAC, and the Knee Injury and Osteoarthritis Outcome Score (KOOS). X-ray and magnetic resonance imaging (MRI) evaluations were taken at baseline, in addition to three and 12 months following treatment.
Top-line results showed that patients treated with APS demonstrated:
A 65 percent change in WOMAC pain score from baseline to 12 months contrast to a 41 percent change in the saline group (p = 0.02).
A 49 percent improvement in VAS pain scores contrast to a 13 percent improvement in the saline group (p = 0.06).
No procedure- or device-related serious adverse events, and comparable frequency, severity and relatedness of adverse events as the contrast to the saline group.
The nSTRIDE APS Kit is not commercially available in the United States but is presently marketed in Europe, via CE Mark, and in Japan, where it is sold as the APS Kit. Results from the PROGRESS II study formed the basis for two additional confirmatory trials: the PROGRESS IV trial (NCT02905240), which received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in July 2016 and is presently enrolling patients, and the PROGRESS V trial (NCT03182374), which is underway in Europe to support global reimbursement efforts.
“As a global leader in musculoskeletal healthcare, Zimmer Biomet is committed to addressing the needs of patients along the entire continuum of care, from the administration of symptoms like pain and stiffness with safe, non-invasive intra-articular injections like APS and Gel-One®, to restoring joint function and mobility with our extensive portfolio of implant systems to treat advanced orthopaedic disease,” said David Nolan, Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle, Office Based Technologies and Zimmer Biomet Signature Solutions. “The positive results of the PROGRESS II trial not only reinforce the safety and clinical value of the autologous anti-inflammatory protein solution prepared with the nSTRIDE APS Kit but also lay the groundwork to advance our regulatory efforts in the United States and accelerate our commercial adoption and expansion in Europe and Asia-Pacific.”