Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) Commences Phase II Clinical Trial of IV Ampion in Coronavirus Patients Worldwide

Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) showcased the safety of intravenous (IV) Ampion in patients suffering from coronavirus during Phase 1 clinical study.

Ampio conducted a controlled and randomized clinical study of IV Ampion in hospitalized patients with severe coronavirus. It evaluated the primary endpoint of the vaccine after a 5-day treatment period. The company measured the safety profile of the vaccine in the following 90 days.

Half of the patients in the cohort are administered with a standard of care (SOC) and IV Ampion Plus whereas the second half with SOC alone. Observations of Phase 1 clinical trial are as follows:

The safety monitoring committee, who reviewed the data, said the treatment with IV Ampion in COVID-19 patients is safe in Phase 1 clinical study for 90 days.

The primary endpoints are met during the first five days of treatment and in the next three months with no adverse safety differences between patients administered with SOC and Ampion.

The patients administered with Ampion showed improved clinical response compared to patients given with SOC.

Initiates Phase II clinical study of IV Ampion

Ampio plans to conduct a Phase II clinical study of IV Ampion worldwide in a large group of patients with COVID-19. It will carry out the study at various sites in the US and Israel. The company considered Israel sites because the FDA accepts it as a trusted and knowledgeable to share important information for supporting efficacy and safety of the drug in the US.

The invitro administration of Ampion interrupts cytokine storm, which is associated with coronavirus infection. The company will target the systemic inflammation in the body of a COVID-19 patient.

Ampio enters a research accord

Ampio signed a research accord with one of the top and oldest children’s hospitals in the US. It intends to study the signaling pathways and anti-inflammatory properties of Ampion in curing certain inflammatory and rare IPD (inflammatory pediatric diseases).

The formulation – Ampion is in a clinical study in curing coronavirus related ARDS (acute respiratory distress syndrome) and inflammation caused due to osteoarthritis. Ampion showed significant improvement in lowering inflammation.

A well known research scientist, Dr. Andrew Terker inked a research accord with Ampio to investigate anti-inflammatory properties of the drug to treat chronic and acute kidney disease.

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