Ampio Pharmaceuticals announced it received FDA approval of the Company's special protocol assessment (SPA) of a clinical protocol titled "A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee."
The FDA response noted "We have completed our review, and based on the information submitted, agree that the design and planned analysis of your study adequately address the objectives necessary to support a regulatory submission. However, final determinations for marketing application approval are made after a complete review of the marking application and are based on the entire data in the application."
"The Company has identified and engaged 15 clinical sites for the trial (AP-013) and patient identification is underway,” Michael Macaluso, Ampio CEO, said. “This pivotal trial seeks to enroll approximately 1,000 patients, with an interim look, to allow sample size adjustments, if required. This trial will assess co-primary endpoints of pain and function. More details of the study will be made available on clinicaltrials.gov."
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A SPA is a process in which sponsors may ask to meet with the FDA to reach agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. A SPA agreement would indicate concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future Biologic License Application (BLA). The elements of the study agreed upon in the SPA agreement are critical to ensuring that the trial conducted under the protocol can be considered an adequate and well-controlled study that can support marketing licensure of Ampion. However, a SPA agreement will not indicate FDA concurrence on every protocol detail, and the FDA may still require us to conduct additional clinical trials in the future to support a BLA for Ampion.
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA 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.