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Ampio Pharmaceuticals (NYSE American: AMPE), a clinical stage biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, presented March 24, 2021 at the Benzinga Biotech Small Cap Conference.
By Mark Gilman
Ampio Pharmaceuticals (NYSE American: AMPE), a clinical stage biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, is not only currently working on a large Phase III trial for its anti-inflammatory drug, Ampion™, in osteoarthritis of the knee (OAK), but it has recently revealed early positive results in its AP-014 Phase I clinical trial using inhaled AmpionTM to treat COVID-19 respiratory distress. Whether or not injected for the knee, inhaled for the lungs, or infused intravenously for systemic COVID-19 symptoms, the delivery of Ampion could potentially solve inflammation distress throughout the entire body.
AmpionTM is a biologic drug which contains blood-derived cyclized peptides and small molecules which utilize the power of the innate immune response to interrupt the damaging cycle of inflammation from injury and disease. By regulating the immune response in suppressing the production of inflammatory proteins and activating anti-inflammatory proteins, the drug can shift the cycle of inflammation back towards tissue repair and healing.
Ampion™ has been shown to reduce hospital stays in COVID-19 patients by 30%, as well as reducing all-cause mortality. On the basis of those results, Ampio is moving to Phase II trials of Ampion™ in treating COVID-19 patients. As Michael Macaluso, Chairman and Chief Executive Officer of Ampio Pharmaceuticals, recently explained, "We shared these promising results with the FDA in our recent request to expand the [AP-014 Phase I] trial. The FDA's response recommended that we forego our planned unblinded expansion of the current trial and move directly to a randomized, double-blinded, placebo-controlled Phase II study of inhaled Ampion™ in COVID-19. It is also important to note that the data was presented to the FDA for guidance as a potential Emergency Use Authorization (EUA) therapy."
In addition to OAK and COVID-19, Ampio is also exploring the use of AmpionTM in kidney and pediatric conditions. In collaboration with physician scientists at Vanderbilt University, Ampio Pharmaceuticals is studying the effects of the drug on inflammation in kidney function, as many kidney disorders involve inflammation. The preclinical research is being done in vitro on renal endothelial cells as well as on proximal tubular epithelial cells of the kidney, all cells involved in the pathophysiology of kidney inflammation.
As the world continues to fight the health effects of the pandemic, Ampio Pharmaceuticals is undergoing clinical trials for AmpionTM focused on those patients afflicted with COVID-19 as well as patients suffering from severe (KL-4) osteoarthritis of the knee (OAK). Both conditions impact a significant percentage of the population, and, due to the lack of any FDA approved drugs for treatment, there exists significant unmet medical needs for both.
AmpionTM is backed by an extensive global patent portfolio with intellectual property protection extending through 2035. In addition, it will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).
Among its current R&D programs and collaborations, Ampio Pharmaceuticals is currently working on:
Robust internal research and a development pipeline as inflammation is implicated in a variety of prevalent diseases and orphan conditions
The study of inflammatory kidney disease in conjunction with researchers at Vanderbilt University
A Collaboration Agreement with one of the top children's hospitals in the U.S. to study inflammatory pediatric diseases including Fontan and Kawasaki Disease.
Ampio Pharmaceuticals is also setting the standard for controlling costs by operating its own turnkey, state-of-the-art manufacturing facility in Englewood, Colorado, supplying clinical material for injection, inhalation and IV studies with capacity for global distribution. The facility also utilizes a modular "clean room" which can be replicated anywhere in the world. The facility has been designed to meet all U.S. and E.U. regulatory standards, and, by controlling the supply chain, Ampio can control the cost of materials and ensure continuity of supply.
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