Apellis Announces New Data Demonstrating Correlation between Complement Activation and COVID-19 Severity - Seite 3

Based on the results, an independent data monitoring committee recommended continuing the investigation of APL-9 in this study. Apellis is currently enrolling an additional 60 patients with COVID-19 and respiratory failure who require oxygen supplementation or mechanical ventilation into the randomized, double-blind, controlled phase of the study to evaluate the safety and efficacy of APL-9 (as add-on to standard care for up to 21 days).

Detailed results from both studies will be submitted for future scientific publication.

About the Observational Study
The observational exploratory study evaluated the relationship between markers of complement activation and disease severity in 41 patients with COVID-19. Patients in the observational study had blood drawn at baseline and at subsequent visits for up to six weeks. The primary objective of the observational study was to quantify systemic concentrations of the complement activation products Bb, C3a, C4a and terminal complement complex (TCC) and correlate them to COVID-19 severity. Secondary objectives were to quantify concentrations of C3 and C4 in serum and proinflammatory T-cell populations (CD4, CD8 and TH17) in whole blood and correlate them to COVID-19 severity. The exploratory objectives were to quantify the concentrations of interleukin 6 (IL-6) and C-reactive protein (CRP) in plasma and serum, respectively, and correlate them to COVID-19 severity. Additional detail and study results can be found on the Events and Presentations section of the Apellis website.

About the Interventional Phase 1/2 Study
The Phase 1/2 study (NCT04402060) is designed to evaluate the safety and feasibility of targeting C3 with APL-9 as an add-on therapy to standard of care in 66 patients with severe COVID-19. Patients included in the study have respiratory failure requiring oxygen supplementation or invasive or noninvasive mechanical ventilation. Patients are treated with APL-9 via intravenous (IV) infusion with an initial dose of 540 mg in the first 24 hours of dosing, followed by 360 mg/day on all subsequent days. 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 (blood clotting). In the preliminary phase, six patients received open-label APL-9 treatment either until the end of study drug administration at day 7 or resolution of acute respiratory distress syndrome (ARDS). Based on the results, an independent data monitoring committee recommended continuing the investigation of APL-9 in this study. Apellis is enrolling an additional 60 patients into the randomized, double-blind, controlled phase of the study to evaluate the safety and efficacy of APL-9 (as add-on to standard care for up to 21 days). Additional detail and preliminary results can be found on the Events and Presentations section of the Apellis website.