Ampio Pharmaceuticals Inc has announced that its AP-014 Phase I inhaled Ampion clinical study in Covid-19 patients is proceeding to full open enrollment after clearance by the Safety Monitoring Committee (SMC).
Ampio is a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions.
It said the SMC found Ampion to be safe and well-tolerated after reviewing results from the first three treatment groups. The trial can now accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment.
Michael Macaluso, President and CEO of Ampio Pharmaceuticals, 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 enrollment of patients will proceed quickly, perhaps doubling the number of patients enrolled by the end of today. We were also encouraged,” Macaluso added.
He also said that by a letter they received from staff at the hospital, sharing the dramatic improvement seen in a patient after using nebulized Ampion.
Full confirmation
Full confirmation of Ampion’s efficacy awaits the conclusion of our clinical trial, but it is heartening to hear good news when it comes to Covid-19, according to Macaluso.
During the trial, Ampion is given to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for Covid-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe.
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Being conducted in the United States, the trial will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 ml doses of Ampion four times a day for five days.
(With inputs from The OnLook News Research Bureau)
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