Ampio Pharmaceuticals announced that it plans to submit an expanded access protocol to the FDA to study the effects of a nebulized formulation of its Ampion anti-inflammatory biologic in patients with moderate to severe acute respiratory distress syndrome (ARDS) caused by COVID-19.
The company said that it expects to evaluate the effectiveness of inhaled Ampion in reducing time on a ventilator, improving oxygenation parameters, and reducing mortality. Ampio also said that it will halt a Phase 3 study of injected Ampion for severe osteoarthritis of the knee due to the COVID-19 pandemic.
Ampion is an aqueous solution containing aspartyl-alanyl diketopiperazine (DA-DKP), an anti-inflammatory, immunomodulating molecule derived from human blood. In 2011, Ampio conducted a study of an intranasal formulation of Ampion for the treatment of nasal inflammation; however, the injectable formulation for osteoarthritis is the only one currently in development.
According to Ampio, “The novel mode of action of Ampion involves multiple biochemical pathways associated with resolving inflammation which make it a potential therapy for ARDS,” and “If Ampion is found to be an efficacious treatment for COVID-19 induced ARDS, the company’s in-house manufacturing facility may allow the product to be produced quickly and in significant quantities.”
Read the Ampio press release.
