Ampio Pharmaceuticals has revealed preliminary positive results of its AP-014 Phase I clinical trial that involves using of inhaled Ampion in treating respiratory distress in patients due to Covid-19.
The preliminary results from the AP-014 Phase I trial indicated that Ampion showed an improvement in all-cause mortality in Covid-19-infected patients as against standard of care (Soc ). A lower all-cause mortality rate of 8% was seen in the Ampion treatment group, while it stood at 21% in standard of care group.
It was also found that patients who were given Ampion required less hospitalisation time, with the average hospital length of stay being seven days for the Ampion group as against 11 days for standard of care patients.
Patients who received Ampion required less oxygen than standard of care alone, and 86% of Ampion treatment group were found to be stable or had improvement as against 75% of SOC group.
By day 5, 86% of patients who were given Ampion were found to be stable or had improvement as against 75% of standard of care patients.
The preliminary results indicated that adverse events were the same between Ampion treatment group and SOC group. There were no drug-related serious adverse events.
Ampio Pharmaceuticals chairman and CEO Michael Macaluso said: “We shared these promising results with the FDA in our recent request to expand that trial. The FDA’s response recommended that we forego our planned unblinded expansion of the current trial and move directly to a randomized, double-blinded, placebo-controlled Phase II study of inhaled Ampion in Covid-19.
“It is also important to note that the data was presented to the FDA for guidance as a potential Emergency Use Authorization (EUA) therapy.”
The firm also revealed its progress toward commencing a Phase I clinical trial utilising inhaled Ampion for treating patients suffering with respiratory effects after contracting Covid-19 infection, which is now called as Covid-19 ‘long haulers’, or clinically termed as Post-Acute Sequelae of SARS-CoV-2 (PASC).
Macaluso added: “The complications from Covid-19 stem not from the virus but from the out-of-control inflammatory immune response it triggers, which remains a problem long after the infection is over. We believe that inhaled Ampion could provide a significant therapeutic benefit for those patients plagued by PASC (“long haul symptoms”).
“And, because Ampion is a platform biologic, what we learn in our upcoming trial could be applicable to a significant number of diseases displaying similar inflammatory-type characteristics, not just Covid-19.”
The trial design will particularly handle respiratory distress-related symptoms. It will feature an ‘at home’ treatment, wherein patients will be given a nebulizer and a five-day supply of inhaled Ampion.
Currently, the trial protocol is being finalised. Commencement of this trial is expected by mid-Q2 2021.
Meanwhile, Ampio, in collaboration with Vanderbilt University , is studying the impacts of Ampion on inflammation in kidney function, given that most kidney disorders involve inflammation.
The preclinical study is being conducted in vitro on renal endothelial cells and on proximal tubular epithelial cells of the kidney, with all cells involved in the pathophysiology of kidney inflammation.
Ampio Pharmaceuticals director and founder David Bar-Or said: “The results so far are promising as Ampion’s method of action aligns both theoretically and is confirmed by initial in vitro experiments on those cells.”