Ampio Pharmaceuticals, Inc. (NASDAQ:AMPE), a biopharma developing immunology-based therapies for inflammatory diseases, announced Monday it has received approval to initiate a clinical study of its lead asset for long COVID-19 treatment.
Ampion's COVID-19 Study: Englewood, Colorado-based Ampio said an investigational review board has approved the initiation of a Phase 1 study, dubbed AP-018, of its inhaled Ampion in patients exhibiting prolonged respiratory COVID-19 symptoms.
This condition is called long/long-haul COVID, or post-acute sequelae of SARS-CoV-2, the virus that causes COVID-19 disease.
The Need For Long COVID-19 Treatment: With about 3 to 10 million individuals suffering from long COVID-19, this trial assumes importance in that it is expected to address a major and ongoing unmet medical need, according to Ampio CEO Michael Macaluso.
A significant percentage of patients who have contracted COVID-19 over the last year continue to suffer debilitating effects long after the virus is flushed out of the system.
This, according to Ampio, is due to the out-of-control inflammatory response the virus triggers.
In late April, Ampio reported positive results from the AP-014 Phase 1 study of inhaled Ampion in treating respiratory distress in COVID-19 patients.
Ampion's Study Design: The Phase 1 study will evaluate the safety and efficacy of inhaled Ampion in adults with prolonged respiratory complications after COVID-19 infection.
The company said it expects to enroll 30 participants with a confirmed, symptomatic COVID-19 diagnosis who continue to experience at least two COVID-19 respiratory symptoms.
These participants will be randomized into two groups and administered the treatment candidate or placebo and followed up for 60 days after treatment.
The primary endpoint is the incidence and severity of adverse events and serious adverse events from baseline to day 28 and day 60. In terms of the efficacy, the company will assess the effect of inhaled Ampion vis-à-vis placebo on the clinical outcomes for participants.