ENGLEWOOD, Colo., Feb. 6, 2019 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced it had received an initial response from the U.S. Food and Drug Administration (FDA), Office of Tissue and Advanced Therapies division regarding the Company’s submission of a proposed trial design for the treatment of KL4 Osteoarthritis patients with Ampion™. The trial design includes concurrent controls and would be carried out under a Special Protocol Assessment (SPA).
Michael Macaluso, Ampio’s CEO, explained: “A SPA is an agreement between the sponsor and FDA that the trial design, clinical endpoints, and statistical analyses could support marketing approval. The recently received FDA correspondence included guidance and questions that require a response from Ampio, which is routine under these circumstances. We are preparing our response to their comments that will include additional questions to allow maximum clarity. We will provide an update as soon as this process is completed.”
Osteoarthritis (OA) is an incurable and 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.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.