Ampio Pharmaceuticals
Ending the Cycle of Chronic Inflammation

Chronic inflammation and immune disorders can be debilitating and deadly. By some estimates, more than 50 percent of all deaths are attributable to inflammation-related diseases such as ischemic heart disease, stroke, cancer, diabetes mellitus, chronic kidney disease, non-alcoholic fatty liver disease (NAFLD) and autoimmune and neurodegenerative conditions.

“In osteoarthritis alone,” commented Holli Cherevka, COO of Ampio Pharmaceuticals, “there are over 200 million patients worldwide suffering from osteoarthritis. And the impact of osteoarthritis is much more than pain; patients with osteoarthritis of the knee, or OAK, are 1.6 times more likely to die from any cause. They're much more likely to experience psychological distress. If you compare patients waiting for a knee replacement, they score much, much lower on quality of life measures than patients with heart failure.”

Ampio Pharmaceuticals, a development-stage biopharmaceutical company, is using its innovative therapeutic discovery and development platform to introduce a novel biologic drug for inflammatory diseases, with limited side effects. Ampio is developing a non-steroidal anti-inflammatory drug, Ampion™, currently in clinical trials, which can be administered for a long time at an affordable cost.

Because Ampion is a platform biologic built on a unique immunomodulating mechanism of action that suppresses inflammation while promoting healing, it has application across different routes of delivery or drug administration. Ampio has developed manufacturing capability in-house to control costs to support the flexible pricing needed to span multiple different indications with a global distribution.

“As we talk about the anti-inflammatory effects of Ampion,” says Cherevka, “it's important to understand that this is different from anti-inflammatory therapies now on the market in that it comes across multiple different transcription pathways.” Unlike a monoclonal antibody that targets only one transcription pathway in the body, Ampion targets multiple pathways to achieve its overall combined effect.

That allows Ampion to show efficacy in indications, such as osteoarthritis of the knee, where patients have not had many options before.

Ampio was in the final stages of a registrational Phase III clinical trial of an intra-articular injection of Ampion in treating severe OAK when the COVID-19 pandemic hit last year. Demonstrating Ampion’s potential as a platform biologic, Ampio quickly pivoted to clinical studies focused on the deadly respiratory complications of COVID-19, which are driven by inflammation caused by an out-of-control immune response. These COVID-19 studies involve Ampion delivered both intravenously (IV) and via nebulizer (inhaled).

“Medical science is just beginning to understand how dangerous chronic inflammation can be, and there are limited treatment options. Steroids are useful, but they have too many side effects,” explained Michael Macaluso, Chairman and CEO of Ampio. “When you think about osteoarthritis of the knee, there's not been a novel mechanism of action in that market space in terms of treatment options in over 20 years. COVID-19 also highlights the urgent need for better and safer anti-inflammatory treatments. Those are just two examples of Ampion’s strength as a platform therapeutic with broad applicability.”

Based on Ampio’s research, Ampion is proved to be safe and well-tolerated with minimal adverse events, providing an anti-inflammatory option for chronic conditions. The studies in OAK showed a statistically significant reduction (40 percent) in pain and an improved body function and quality of life at 12 weeks compared to patients who received the saline control. Similarly, in a Phase 1 trial in COVID-19, Ampion reduced all-cause mortality in COVID-19 respiratory distress by nearly 80 percent over Standard of Care treatment alone.

Ampio Pharmaceuticals continues to plan for the future, conducting an early clinical trial in “Long Haul” COVID-19 and pre-clinical research on Ampion’s use in kidney disease and incurable pediatric diseases. Manufacturing the drug in-house based on international standards is also an investment in the future, supporting not only consistency of manufacturing but also cost control, making Ampion affordable enough to be used everywhere around the world.