Ampio Reveals Positive Data In Phase 1 Trial Of Inhaled Ampion In COVID-19 Respiratory Distress

(RTTNews) - Ampio Pharmaceuticals Inc. (AMPE) announced early positive data from its ongoing U.S. Phase I controlled, observer-blinded clinical trial of inhaled Ampion compared to standard of care for patients with COVID-19 respiratory distress (AP-014).

The preliminary analysis of data showed that patients receiving Ampion treatment required less oxygen than standard of care alone. Patients who received Ampion treatment were stable or had improvement on the ordinal scale for clinical improvement compared to the standard of care patients.

Patients who received Ampion treatment were stable or had improvement on the National Early Warning Score 2 scoring system (NEWS2) compared to the of standard of care patients.

The analysis also showed that Ampion treatment improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care. There have been no drug-related serious adverse events.

On the positive data, Ampio said it plans to increase the number of patients in the trial from 40 to 140 and has added additional hospitals as study sites. The new hospitals will accelerate the pace of patient enrollment, and the additional data gained from the added patients will help refine and accelerate future clinical trials, as warranted.