Friday December 4, 2020 0 comments
ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) announced its AP-014 Phase I inhaled Ampion clinical study in COVID-19 patients is proceeding to full open enrollment following clearance by 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 accelerate to complete enrollment of the remaining 34 patients at the speed of recruitment.
"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," said Michael Macaluso, president and CEO of Ampio Pharmaceuticals.
"The enrollment of patients will proceed quickly, perhaps doubling the number of patients enrolled by the end of today.
"We were also encouraged by a letter we received from staff at the hospital, sharing the dramatic improvement seen in a patient after using nebulized Ampion.
“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."
In the trial, Ampion is administered 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.
This trial, being conducted in the United States, 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 (4) times a day for five (5) days.
Safety is the primary end point, and various measurements indicative of efficacy are secondary endpoints. Since 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 enrollment.
In related news, the Journal of Translational Medicine this week published a peer-reviewed paper on the method of action of Ampion, entitled "LMWF5A suppresses cytokine release by modulating select inflammatory transcription factor activity in stimulated PBMC," by G. Thomas, et al.
The research provides evidence that Ampion, a low molecular weight fraction of human serum albumin (LMWF5A), reduces pro–inflammatory cytokine release by activating the immunoregulatory transcription factors PPARγ and AhR while also suppressing NF–κB and STAT1α pro–inflammatory pathways.
"This paper, in a high-impact journal, confirms that Ampion reduces inflammation through multiple pathways, unlike many other anti-inflammatory therapies that target only one," said Macaluso.
"Inflammation is one of the body's most important survival mechanisms, so suppressing only one pathway merely forces the body to activate other pathways.
“Ampion targets multiple pathways simultaneously to interrupt the destructive cycle of inflammation and disease observed in many different inflammatory conditions."