Apellis Pharma Initiates Phase 1/2 Study Of APL-9 In Patients With COVID-19

(RTTNews) - Apellis Pharmaceuticals Inc. (APLS) said that it has initiated a Phase 1/2 clinical study of APL-9, an investigational C3 inhibitor designed for acute interventions, in COVID-19 patients with respiratory failure including acute respiratory distress syndrome or ARDS.

ARDS is a life-threatening form of lung failure that involves overactivation of complement, a part of the body's immune system.

In COVID-19, complement activation has also been found to be strongly associated with organ failure and thrombotic events, which involve the abnormal formation of blood clots and are an emerging cause of mortality in COVID-19 patients.

Apellis initiated the Phase 1/2 study following preliminary results from its ongoing, non-interventional study in patients with ARDS secondary to COVID-19, which showed a substantial increase in the activation of the complement cascade.

The Phase 1/2 study is expected to enroll 66 hospitalized patients with COVID-19 and respiratory failure who require oxygen supplementation or mechanical ventilation.

The primary objective of the study is to assess the safety of APL-9 as an add-on to the current standard of care. Secondary objectives include evaluating length of stay in the hospital, overall survival, time on oxygen therapy or mechanical ventilation, and markers of complement activation, organ failure, and coagulation.