ENGLEWOOD, Colo., May 22, 2018,/PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a poster presentation on the mechanism of action of a component of Ampion™ will be presented at AAST and the most recent study of Ampion treatment of Severe Osteoarthritis of the Knee ( AP-007-B) has been accepted for publication by PSS.
Dr. David Bar-Or, Ampio’s CSO explained:
- “A study was accepted for presentation as a scientific poster, entitled “The Anti-Inflammatory Effect of LMWF5A (Ampion) and N-Acetyl Kynurenine on Macrophages: Involvement of Aryl Hydrocarbon Receptor in Mechanism of Action”, at the 2018 American Association for the Surgery of Trauma (AAST) annual meeting to be held on September 26-29 in San Diego, CA.”
- “This poster details a partial mechanism of action (MOA) for Ampion. We have reported in the previous peer-reviewed journals that Ampion promotes the activation of anti-inflammatory macrophages while decreasing the activation of pro-inflammatory macrophages. In this poster, we report that Ampion significantly decreases the release of pro-inflammatory biomarkers from LPS-stimulated macrophages while a known component of Ampion (N-acetyl kynurenine or NAK) also decreased these biomarkers. When an inhibitor of the aryl hydrocarbon receptor (AhR) was included, the anti-inflammatory effect of Ampion was partially blocked while the effect of NAK was completely attenuated.”
- “This is an important finding since activation of the AhR suppresses inflammation by limiting the secretion of pro-inflammatory cytokines and promoting the overexpression of immuno-modulatory mediators. In the literature, it is well known that kynurenine is an agonist of AhR, but our study is the first to describe NAK as a potential AhR agonist. These findings suggest that Ampion and a component (NAK) partially promote the suppression of activated macrophages via the AhR receptor. Therefore, Ampion which contains NAK is a useful therapeutic in medical conditions where inflammation is prevalent such as trauma, osteoarthritis, sepsis, and wound healing.”
- “The AP-007-B study was accepted for publication in the peer-reviewed journal Patient Safety in Surgery. The article, entitled “Incidence of total knee replacement subsequent to intra-articular injection of the anti-inflammatory compound [Ampion] versus saline: a long-term follow-up study to a randomized controlled trial” is authored by John Schwappach, Joseph Schultz, Kristin Salottolo, and David Bar-Or.”
- “The objective of study AP-007-B was to explore the effect of Ampion on delaying total knee arthroplasty (TKA). Patients were recruited from the population who participated in the AP-007 trial (www.ncbi.nlm.nih.gov/pubmed/?term=Preliminary+Trial+of+Intra-articular+LMWF-5A+for+Osteoarthritis+of+the+Knee). A telephone survey was utilized to determine TKA status approximately three years after treatment with Ampion or saline vehicle control in the randomized, controlled AP-007 clinical trial. The primary endpoint was the incidence of TKA (%), presented by treatment arm overall and in the KL4 subset. The survey response rate was 87%, and the overall rate of TKA was 38.5%. TKA rates were higher in more severe osteoarthritis (KL4: 56% vs. KL3: 26%). In the severe KL4 subset, treatment with Ampion resulted in a lower rate of TKA compared to saline vehicle arm (40% vs. 83%). This result supports previous findings that the treatment effect of Ampion is greatest in patients with the more severe disease. Further, in patients who responded to treatment during the AP-007 trial (≥20% reduction in pain), TKA rates were significantly lower in the Ampion arm compared to the saline vehicle arm (14% vs. 100%, respectively p=0.03). Study AP-007-B reports a meaningful delay in TKA for patients with severe osteoarthritis treated with Ampion, supporting the in vitro and in vivo work suggesting that LMWF-5A has the potential to provide structure modifying/preserving therapy in this population.”
- A link to the full manuscript will be made available when it is published online.
Regulatory Exclusivity and IP protection:
The Company believes that Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a “reference product” upon FDA approval of their BLA. Reference products are granted twelve years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product. The existing Ampion™ portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035.
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.
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 Biological License Application (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.
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