Ampio publishes on anti-inflammatory mechanisms of med

Ampio Pharmaceuticals, Inc. (NYSE: AMPE) today announced a basic science manuscript entitled “The Anti-Inflammatory Effect of LMWF5A and N-Acetyl Kynurenine on Macrophages: Involvement of Aryl Hydrocarbon Receptor in Mechanism of Action” has been accepted for publication in Biochemistry and Biophysics Reports.

Dr. David Bar-Or, Ampio’s CSO explained, “This biochemical research uncovered an important part of the mechanism of action of Ampion™ or the low molecular weight fraction of 5% human serum albumin (LMWF5A). We had previously demonstrated that Ampion promotes the activation of anti-inflammatory macrophages while decreasing the activation of pro-inflammatory macrophages.

Here, we show that Ampion significantly decreases the release of pro-inflammatory biomarkers from LPS-stimulated macrophages and that one of the known components of Ampion (N-acetyl kynurenine or NAK) also decreased these biomarkers – albeit to a smaller extent. 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 prevented.

This is a significant 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 (through) one of its active components (NAK) promote the suppression of activated macrophages, partially via the AhR receptor. Therefore, Ampion, which contains NAK and other anti-inflammatory active moieties, is potentially a useful therapeutic in medical conditions where inflammation is prevalent such as trauma, osteoarthritis, sepsis, and wound healing.”

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.

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