ENGLEWOOD, Colo., February 21, 2020, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) a development stage biopharmaceutical company, executing a Special Protocol Assessment (“SPA”) Phase III clinical trial titled “Evaluating the Efficacy and Safety of AmpionTM to treat Adults with Pain Due to Severe Osteoarthritis of the Knee”, today announced updates regarding the continued progress of its Phase III AP-013 clinical trial and receipt of its annual audit opinion.
Clinical Trial Update
The AP-013 clinical trial is designed to evaluate the effect of Ampion on pain and function at 12-weeks in patients with severe osteoarthristis of the knee (“OAK”). This design would position Ampion as the first OAK therapy on the market to address pain and function, and have a label and efficacy data for the severely diseased patient population, if approved. As of February 14, 2020 the following had occurred:
- of the 1,034 patients to be enrolled in AP-013, 875 patients had been dosed with enrollment continuing to progress. Exclusions for participation in the trial average approximately 35% in order to ensure enrollment of only patients with severe osteoarthritis of the knee who do not have other pain or medical conditions that could interfere with their assessment of the pain and function in the injected knee.
Receipt of Audit Opinion with Going Concern Qualification
The Company is required under the NYSE American Company Guidelines Sections 401(h) and 610(b) to publish certain disclosures. As previously disclosed within its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the Securities and Exchange Commission on February 21, 2020, 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, 2019. A copy of the Company’s Form 10-K is located on the Company’s website at www.ampiopharma.com/investors/financial-filings. Shareholders also have the ability to receive a hard copy of the Company’s Form 10-K free of charge upon request.
About Special Protocol Assessment
A SPA is a process in which sponsors may ask to meet with the FDA to reach an 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. Our SPA agreement for the above referenced study indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design for the study, which we intend to support a future Biologic License Application (“BLA”).
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.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio’s lead drug, AmpionTM, is backed by an extensive patent portfolio with intellectual property protection extending through 2032 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (“BPCIA”).
Ampio’s statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the BLA, the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Daniel G. Stokely, CFO
Phone: (720) 437-6500