Ampio Pharma To Initiate Final Pivotal Trial For Ampion - Quick Facts

(RTTNews) - Ampio Pharmaceuticals Inc. (AMPE) announced receipt of FDA correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion for the treatment of osteoarthritis of the knee or OAK. The firm said it will initiate the final pivotal trial for Ampion biological license application or BLA.

The company said that the final pivotal trial will confirm the efficacy and safety of the 4 ml injection in approximately five hundred patients with a follow-up of no less than twenty weeks in order to better understand the duration of action. The trial is planned to begin in early January 2014 with an additional six clinical sites added to the nine sites utilized in the SPRING study.

Submission of the BLA, the documents used for approval, could then occur in the third-quarter of 2014.

Osteoarthritis is the most common form of arthritis, affecting over 27 million people in the United States. It 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 or hip over a lifetime is approximately 46% and 25%, respectively. 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.