Apellis Announces New Data Demonstrating Correlation between Complement Activation and COVID-19 Severity - Seite 2

Observational study levels of complement and inflammatory markers

n = 40	Median (range)	ULN	Multiple of ULN (median)	# patients >ULN (% of patients)
Bb, µg/mL	1.37 (0.44, 6.22)	1.49	0.9	16 (40.0%)
C3, g/L	1.36 (0.82, 2.03)	1.62	0.8	5 (12.5%)
C3a, ng/mL	182 (34.8, 679.8)	49.4	3.7	39 (97.5%)
C4, g/L	0.39 (0.08, 1.11)	0.52	0.7	7 (17.5%)
C4a, ng/mL	1612 (658, 3000)	1251	1.3	29 (72.5%)
TCC, ng/mL	187 (109, 1034)	244	0.8	11 (27.5%)
IL-6, pg/mL	19.8 (2.22, 613.37)	11.9	1.7	27 (67.5%)
CRP, mg/L	50.8 (0.8, 361.5)	4	12.7	36 (90.0%)
dLDH, U/L	224 (107, 850)	180	1.2	30 (75.0%)

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
Apellis also announced preliminary results from the first part of the interventional Phase 1/2 study of APL-9 in patients with severe COVID-19. Of the six patients enrolled, all patients had elevated C3a and CRP levels and five of the six patients had elevated LDH levels at baseline. Five patients completed the study and were discharged from the hospital. Additionally, in these patients, C3a, LDH and CRP levels were within the normal reference range by the end of the APL-9 treatment period. Three patients experienced four treatment-emergent adverse events (TEAEs), which were all considered unrelated to study treatment. One serious adverse event of respiratory failure, which was considered unrelated to the study treatment, led to death from failed intubation.