ENGLEWOOD, Colo., February 27, 2017 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced that the Office of Tissue and Advanced Therapies (OTAT), a branch of the Center for Biologics Evaluation and Research (CBER) of the FDA, has recently provided additional guidance for the path to approval of Ampion™ as a treatment for pain due to severe Osteoarthritis of the knee (OAK).
The FDA acknowledged an unmet medical need in patients with pain due to severe OAK, graded as Kellgren-Lawrence Grade 4 (KL 4), where there are currently no FDA approved treatments for this population.
“Ampion™ has demonstrated a promising effect with a responder rate defined by Osteoarthritis Research Society International (OARSI), of greater than 50% in all of the completed single-injection Ampion™-trials with no drug-related Serious Adverse Events” stated Michael Macaluso, CEO of Ampio. “Additionally, combined analysis of this population in our prior single-injection studies show that Ampion™ was statistically significant in the mean reduction of pain, function and patient global assessment. To our knowledge, Ampion™ has the largest experience in safety and efficacy data in the severe OAK patient population.”
Based on the FDA guidance, Ampio has proposed a small pre-approval study, randomized 6 to 1 (Ampion™/Saline) on patients with severe OAK, defined radiologically as KL 4 patients. The proposed 6-1 randomization is intended to preserve blinding and prevent bias. However, only Ampion™ treated patients will be evaluated. The study will be completed concurrently with preparation for the Biologicals Licensing Application (BLA) submission. The proposed design of this 12-week study evaluates the responder rate of Ampion™ treated patients as defined by OARSI, which includes pain, function, and patient global assessment. The label of Ampion™ will be defined by this study outcome, as we seek a label that includes pain, function, and patient global assessment. Ampio has requested expedited review/approval for this serious medical condition with an unmet medical need.
As soon as practical Ampio will announce a time for a conference call to address corporate strategy, and the expansion of additional indications for Ampion™.
About Osteoarthritis Osteoarthritis (OA) 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 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.
Forward-Looking Statements 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,” “proposed,” “will,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to the Ampion™, and the best path forward to obtain a Biological License, as well as risks associated with clinical trials, expected results, regulatory approvals, our ability to complete future investor conference calls to discuss the Company’s strategies moving forward and changes in business conditions and similar events. These forward-looking statements also include statements regarding our perception of the guidance given to us from CBER related to our proposed small pre-approval study and how the Ampion™ label might be defined and what we will seek for the label to state. 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 Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Gregory A. Gould Chief Financial Officer
Phone: (720) 437-6500