Ampio announced the beginning of an Open Label Extension (OLE) study of Ampion in patients with severe osteoarthritis of the knee (OAK). The OLE study offers patients an opportunity to receive repeat injections of Ampion after they have completed the pivotal clinical trial. This OLE study will address the regulatory requirements to allow an expanded commercial label for repeat administration of Ampion.
Ampion is the low molecular weight fraction of pharmaceutical 5% human serum albumin (HSA). HSA is the sole starting material used to manufacture Ampion and has been given to patients for more than 60 years with a demonstrated safety profile. Ampio leverages the safety profile of HSA to develop a product for patients that has the potential to address the signs and symptoms for the unmet medical need of severe osteoarthritis of the knee.
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.