Ampio Pharmaceuticals has announced that its AP-014 Phase I clinical inhaled Ampion study is proceeding to full open enrolment of Covid-19 patients with respiratory distress.
The latest development follows clearance from the Safety Monitoring Committee (SMC), which found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups.
The trial can now fast track the completion of the remaining 34 patients’ enrolment at the speed of recruitment.
Ampio Pharmaceuticals president and CEO Michael Macaluso said: “The primary goal of this trial is to confirm the safety of inhaled Ampion, so we are pleased the SMC found no concerns after treatment of the first sets of patients.
“The enrolment of patients will proceed quickly, perhaps doubling the number of patients enrolled by the end of today.”
Ampion will be administered to patients by inhalation in the trial, which will allow the drug to target and attenuate inflammation in the lungs.
This will be done using a hand-held nebulizer for Covid-19 patients early in the disease and non-invasive ventilation or face mask and mechanical ventilation or intubation in severe cases.
This trial will have 40 patients in the US who will randomly receive inhaled Ampion versus Standard of Care (SOC).
Each patient will be given 8ml doses of Ampion four times a day for five days.
The trial’s primary end point is safety of the drug and other measurements indicative of efficacy will form the secondary endpoints.
As inhalation is a novel method for the administration of Ampion, cleared for clinical use by the FDA, the SMC analysed each of the first three patient groups receiving inhaled Ampion for three more days.
The SMC observed no safety concerns related to inhaled Ampion in any of these groups and approved to complete the enrolment.
In September, Ampio Pharmaceuticals completed enrolment for its Phase I clinical trial of Ampion intravenous treatment for Covid-19 patients who need supplemental oxygen.