Effects of the treatment with the melanocortin receptor agonist AP1189 in hospitalized COVID-19 patients

INTRODUCTION: COVID-19 is characterized by an initial viral phase followed by an inflammatory phase. AP1189 is a biased melanocortin agonist with significant anti-inflammatory and pro-resolving actions. This study investigated the safety and efficacy of AP1189 on the treatment of patients with severe COVID-19. METHODS: The study was composed of two parts. Part one was a single arm phase of 6 patients to evaluate the safety of administering AP1189 to COVID-19 patients. In the second part, 54 patients were randomized 2:1 to receive standard of care plus AP1189 or placebo in a double-blind manner. AP1189 or matched placebo was given as an oral suspension once daily for up to 2 weeks from initiation of supplementary oxygen therapy. The primary efficacy endpoint was the number of days taken for patients to achieve respiratory recovery, defined as a value of peripheral oxygen saturation (SpO2) ≥ 93% for 30 min at room air. RESULTS: In total, 42 patients were assigned to AP1189 while 18 received placebo. All patients were given systemic glucocorticoids as standard of care. The AP1189 group took a median (IQR) of 4 (3, 7) days vs. 6 (4, 12) days on placebo to achieve respiratory recovery (p<0.0001). Patients treated with AP1189 had shorter hospital stay, median of 6 days (4, 8), when compared with placebo, 7.0 days (5, 14) (p<0.0001). The safety profile was similar for AP1189 and placebo. CONCLUSION: Treatment with AP1189 was safe in severe COVID-19 patients already taking glucocorticoids and was effective in decreasing time for respiratory recovery and length of hospital stay.