Clinical Assessment of CX-011 for Pain Relief, Increased Function, and Potential Disease-Modifying Treatment for Knee Osteoarthritis
Abstract
Topic Area: Arthritis; Strategic Goal: Treatment. Osteoarthritis (OA) is a degenerative joint disease, characterized by the progressive loss of cartilage that causes stiffness, swelling, and pain. Often resulting from a joint injury, OA affects nearly 10% of the world’s population, making it the most common form of arthritis and one of the most common pathological conditions. In the United States, there are over 27 million people affected by OA, with this number projected to climb steeply due to a rapidly aging population and increasing obesity rates. Each year, over $185 billion is spent to treat OA globally, establishing this disease as a major burden on global health and economics. Service Members develop OA earlier in life and more often than civilians, necessitating long-term care and often reducing their ability to serve. Moreover, Soldiers injured by roadside bombs or other blast-related injuries often develop OA within 2 years, or five times faster than civilians suffering injuries. OA is the most common condition that renders Soldiers unfit for duty, thereby decreasing morale and readiness. In addition, Veterans are twice as likely to suffer from OA than civilians. There are currently no treatments to slow the loss of cartilage in patients with OA. Instead, doctors focus on modifying lifestyle, managing pain, and improving joint function, with the overall goal of delaying joint replacement surgery. For those with mild OA, initial therapies include weight loss, physical therapy, and pain management using over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs). As the condition progresses to a moderate stage, injections into the joint space are used to increase joint lubrication and/or reduce inflammation while continuing physical therapy and other exercises. If the disease progresses to a severe stage, opioid-based pain control is introduced in conjunction with the therapies used in previous stages. Finally, if none of these previous tares able to lessen the pain, total joint replacement surgery is considered. There are over 1 million knee and hip replacements performed each year in the U.S, at a cost of over $50 billion. Unfortunately, mechanical joints have a limited lifetime, and conducting multiple joint replacements on the same joint is very difficult on the body and has a high failure rate; this is particularly troubling for our Wounded Warriors who may require joint replacements early in life. Here we propose to conduct the first human studies of a potential new therapy for OA called CX-011. This medicine would be injected into the joint, where it would block a signal that drives cartilage loss and pain. By intercepting this key signal that drives the development of OA, CX-011 would be the first medicine to prevent disease progression instead of just treating the symptoms. Other possible benefits would include reducing pain and increasing mobility, as well as potentially regenerating cartilage. These improvements would be likely to occur in the weeks following the first injection, with additional injections every few months resulting in further benefits. Our results so far have shown that the effects are strongly correlated with the dose; if more of the drug is injected, experimental animals see larger improvements in joint structure and function, as well as pain. The drug has been shown to be very safe, with no side effects observed even at extremely high doses. By advancing the development of a drug to help Veterans and Service Members with OA, the medicine could greatly reduce the burden and progression of OA in Soldiers as well as the general public, thereby improving their lives and those of their families and caregivers. Our team includes the Chief of Orthopaedic Surgery as the West Los Angeles VA Medical Center, the fourth largest VA in the country; she will discuss the trial with Veterans and refer as many as possible for evaluation and enrollment so we can directly begin to see the p
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310289
Entities
People
- Hassan Serhan
Organizations
- United States Army