Ampio Pharmaceuticals, a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced randomization and dosing of patients in its multi-center AP-019 phase II clinical trial, using inhaled Ampion in the treatment of respiratory distress due to Covid-19, is underway.“We saw strong, positive results in our phase I trial, reducing all-cause mortality in Covid-19 respiratory distress by 78%. If this phase II study further confirms the efficacy results seen in our phase I study, I can envision moving forward quickly with an application for Emergency Use Authorization for Ampion in treating patients suffering from respiratory distress due to Covid-19,” said Michael Macaluso, President and CEO of Ampio.As an immunomodulatory agent with anti-inflammatory effects, Ampion interrupts the hyperactive immune response associated with Covid-19 and may improve the clinical outcome for patients suffering from its complications.The company initiated the AP-019, double-blind, placebo-controlled phase II trial, utilizing inhaled Ampion following the strong top-line results achieved from its AP-014 phase I trial. On April 27, 2021, the company reported the earlier phase I study not only met its primary endpoint of safety and tolerability, but top-line results also showed that Ampion reduced all-cause mortality in patients suffering from Covid-19 respiratory distress by 78% over the Standard of Care (SOC). Specifically, mortality in the SOC group was 24%, while in the group treated with Ampion, mortality was only 5%.“Roughly 300 people per day are dying of Covid-19 in the US,” Macaluso continued, “with a seven-day average of 10,000 per day worldwide. There is a perception the vaccine rollout has ended the pandemic, but Covid-19 is likely to remain a concern for some time to come, and physicians need tools to treat it.”Ampio also recently received approval from the FDA to expand the AP-019 study to India, which has recently seen a dramatic surge in Covid-19 cases.
