Ampio Preparing Expanded Access FDA Protocol to Study Ampion for Severe COVID-19 ARDS

Ampio Pharmaceuticals is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2 (COVID-19) induced Acute Respiratory Distress Syndrome (ARDS), an immediately life-threatening condition.

Ampio's Scientific Advisory Board (SAB) members David Bar-Or, MD, Pablo Rubinstein, MD, and Edward Brody, MD, PhD, determined after a careful review of the published articles on the properties of Ampion, that nebulized Ampion may be suitable to treat another inflammatory indication. Specifically, ARDS, one of the most dreaded complications of COVID-19 is associated with widespread inflammation in the lungs. The underlying mechanism of ARDS involves diffuse injury to cells which form the barrier of the microscopic air sacs (alveoli) of the lung, surfactant dysfunction, and activation of the immune system. The fluid accumulation in the lungs associated with ARDS is partially explained by vascular leakage due to inflammation. Ampion is an aqueous solution that may be delivered through nebulization and may be suitable for suppressing inflammation in the lungs.

Ampion is a human blood derived composition, currently approved for clinical use by the FDA, as an anti-inflammatory, immunomodulating drug. The novel mode of action of Ampion involves multiple biochemical pathways associated with resolving inflammation which make it a potential therapy for ARDS as follows:

An important aspect of ARDS, triggered by COVID-19, is an initial release of chemical signals and other inflammatory mediators secreted by lung epithelial and endothelial cells. Neutrophils and some T-lymphocytes migrate into the inflamed lung tissue and contribute to the amplification/deterioration of ARDS. A decrease in the production of lipid mediators of inflammation (prostaglandins) may impair the resolution of inflammation associated with ARDS.

Ampion was reported to up regulate the production of these healing lipid mediators' prostaglandins in-vitro3. In addition, multiple inflammatory signals (i.e. TNF α, IL6, CXCL10) have been reported to be attenuated by Ampion, including a decrease in vascular permeability.

More than 1,000 patients with another inflammatory disease, osteoarthristis, have received Ampion without any serious drug related adverse events. A subset of these patients were given Ampion multiple times over the course of a year, and no serious drug related adverse events were observed.

Ampion is formulated as a sterile liquid and is easily administered as a nebulized liquid form. 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.

The anticipated aim of a preliminary protocol for FDA review would be to evaluate patients with moderate to severe ARDS, triggered by COVID-19, for (1) reduced ventilator time; (2) reduction in mortality and (3) improvements in oxygenation parameters compared to non-Ampion treated patients.

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