Apellis Announces New Data Demonstrating Correlation between Complement Activation and COVID-19 Severity
WALTHAM, Mass., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced observational study results that found a correlation between COVID-19 severity and complement overactivation, which is a key immune response. Additionally, preliminary open-label safety data from six patients in a Phase 1/2 study support advancement of APL-9, an investigational targeted C3 therapy designed for acute interventions, for severe COVID-19. These results also showed that key markers of inflammation were within or near normal range at the end of the APL-9 treatment period.
Observational Study Results
In addition, 39 (97.5%) patients had substantially elevated systemic levels of C3a, a marker for C3 activation, with median C3a levels 3.7 times the upper limit of normal. Multiple complement pathways were activated as evidenced by systemic elevations of C4a, Bb and TCC. Complement overactivation is known to worsen respiratory diseases by killing healthy cells and causing further complications such as blood clots and multiorgan failure, making it difficult for patients to recover.
“These study results demonstrate that multiple complement pathways are going into overdrive in severe cases of COVID-19, reinforcing the critical need for therapies that can regulate overactive complement and improve patient outcomes in COVID-19,” said Lukas Scheibler, Ph.D., Chief Innovation Officer of Apellis. “Targeting C3 has the potential to control complement activation across all three major pathways due to its central location, so we believe it is a strong target to continue exploring.”
Observational study levels of complement and inflammatory markers
n=number of patients with evaluable assessments for each parameter. CRP, C-reactive protein; IL-6, interleukin 6; LDH, lactate dehydrogenase; TCC, terminal complement complex; ULN, upper limit of normal.
Preliminary Results from the Phase 1/2 Study
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
About the Interventional Phase 1/2 Study
Apellis Forward-Looking Statement