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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataAmpio 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.”
