Ampio Pharmaceuticals has started the randomisation and dosing of patients for its AP-019 Phase II clinical trial against long Covid.
The double-blind, placebo-controlled trial will assess the efficacy of inhaled Ampion for treating respiratory distress due to Covid-19.
The biopharmaceutical company initiated the Phase II study following positive results from its AP-014 Phase I trial.
The final results of the Phase I trial indicated that Ampion led to a 78% decrease in all-cause mortality in patients suffering from COVID-19 respiratory distress compared to the standard of care (SOC).
Ampion is a novel biologic drug containing a blood-derived cyclized peptide and small molecules that work together to address a variety of inflammatory conditions.
The agent is being investigated for treating inflammation in the lungs of Covid-19 patients.
Ampio president and CEO Michael Macaluso said: “We saw strong, positive results in our Phase I trial, reducing all-cause mortality in Covid-19 respiratory distress by 78%.
“If this Phase II study further confirms the efficacy results seen in our Phase I study, I can envision moving forward quickly with an application for Emergency Use Authorization for Ampion in treating patients suffering from respiratory distress due to Covid-19.”
The Phase II study will be conducted at multiple centres.
Ampio has also secured US Food and Drug Administration (FDA) approval to expand the AP-019 study to India.
India witnessed a sharp surge in Covid-19 cases earlier this year. It is the second worst affected country in terms of the total number of confirmed Covid cases.
Macaluso added: “Roughly 300 people per day are dying of Covid-19 in the US, with a seven-day average of 10,000 per day worldwide.
“There is a perception the vaccine rollout has ended the pandemic, but Covid-19 is likely to remain a concern for some time to come, and physicians need tools to treat it.”