Ampio Pharmaceuticals initiates dosing in the AP-003-C, Phase 3, single injection Ampion study. This study addresses the "unmet medical need" in Kellgren-Lawrence grade 4 osteoarthritis of the knee (OAK), evaluating the efficacy of Ampion for the treatment of pain, function, and Patient Global Assessment in severe OAK. The study's primary endpoint follows the Outcome Measures in Rheumatology Clinical Trials (OMERACT) and Osteoarthritis Research Society International (OARSI) guidance, utilizing the OMERACT-OARSI responder rate.
Osteoarthritis (OA) is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with age, obesity, and diabetes, this number will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.