Research & Development
Ampio announces full open enrollment for AP-014 Phase I inhaled Ampion clinical study in COVID-19 patients
2 December 2020 -

Biopharmaceutical company Ampio Pharmaceuticals Inc (NYSE American: AMPE) disclosed on Wednesday that its AP-014 Phase I inhaled Ampion clinical study in COVID-19 patients is proceeding to full open enrollment, having been cleared by the Safety Monitoring Committee (SMC).

Ampion was found to be safe and well-tolerated after reviewing results from the first three treatment groups and the trial can now accelerate to complete enrolment of the remaining 34 patients at the speed of recruitment.

During the trial, Ampion is administered to patients by inhalation using a hand-held nebulizer. This allows the drug to directly target and attenuate inflammation in the lungs of COVID-19 patients early in the disease. Non-invasive ventilation (face mask) and mechanical ventilation (intubation) is used if the patient's disease state is more severe.

The trial is being conducted in the US, with 40 patients randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC) and each patient inhaling 8ml doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point, and various measurements indicative of efficacy are secondary endpoints.

As inhalation is a new method for the administration of Ampion, cleared for clinical use by the FDA, each of the first three patient groups receiving inhaled Ampion were assessed by the SMC for an additional three days after the five-day treatment period. No safety concerns arose in any of these groups, and, as such, the trial was approved to complete full enrolment, the company concluded.

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