Ampio Pharmaceuticals announced on March 11, 2019, the Company resubmitted a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA) for a confirmatory Phase III clinical trial of its biological drug, Ampion™, for the treatment of patients afflicted with Osteoarthritis of the Knee (OAK).
"After a series of interactions with the FDA, we believe we have addressed and answered all questions regarding trial design. The FDA confirmed they would respond to our SPA submission no later than April 25, 2019. The FDA guidance regarding our trial design was in agreement with the advice we received from multiple independent statisticians who analyzed our clinical results of nearly 1,000 KL4 patients,” Macaluso, Ampio's CEO said. “These patients, taken as a group, provided statistically significant results compared to patients receiving the saline control. As site recruitment and patient identification for the trial are currently underway, we will provide an update and commence the trial as soon as practicable after the SPA is awarded. The Company believes the anticipated cost of the trial is manageable and within the range of our other OAK trials and we are reviewing all possible financing alternatives including encouraging investors to exercise the outstanding warrants. As recently stated in our 10-K, Ampio will focus all our clinical and financial resources on the approval of Ampion. However, we plan to continue seeking a partnership for Optina™."
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
The Company is required under the NYSE MKT Company Guide Sections 401(h) and 610(b) to publish certain disclosures. As previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the Securities and Exchange Commission on March 18, 2019, the Company's audited financial statements contained a going concern explanatory paragraph in the audit opinion from its independent registered public accounting firm. This announcement does not represent any change or amendment to the Company's financial statements or to its Annual Report on Form 10-K for the fiscal year ended December 31, 2018.
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. 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.