Table 2.
Summary of safety and tolerability
| Placebo (n = 18) | PGZ pooled (n = 67) | PGZ 9 mg QW (n = 12) | PGZ 18 mg QW (n = 21) | PGZ 27 mg QW (n = 18) | PGZ 36 mg Q2W (n = 16) | |
|---|---|---|---|---|---|---|
| TEAEs | 9 (50.0) | 41 (61.2) | 7 (58.3) | 13 (61.9) | 14 (77.8) | 7 (43.8) |
| Grade 1 (mild) | 5 (27.8) | 22 (32.8) | 6 (50.0) | 7 (33.3) | 6 (33.3) | 3 (18.8) |
| Grade 2 (moderate) | 4 (22.2) | 19 (28.4) | 1 (8.3) | 6 (28.6) | 8 (44.4) | 4 (25.0) |
| Grade >3 (severe) | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious TEAEs | 0 | 1 (1.5) | 0 | 0 | 1 (5.6) | 0 |
| Hypertension | 0 | 1 (1.5) | 0 | 0 | 1 (5.6) | 0 |
| TEAEs related to treatment | 2 (11.1) | 23 (34.3) | 5 (41.7) | 6 (28.6) | 7 (38.9) | 5 (31.3) |
| Serious TEAEs related to treatment | 0 | 0 | 0 | 0 | 0 | 0 |
| TEAEs leading to treatment discontinuation | 0 | 4 (6.0) | 0 | 0 | 4 (22.2) | 0 |
| Hypertension | 0 | 1 (1.5) | 0 | 0 | 1 (5.6) | 0 |
| Abdominal pain | 0 | 2 (3.0) | 0 | 0 | 2 (11.1) | 0 |
| Nausea | 0 | 2 (3.0) | 0 | 0 | 2 (11.1) | 0 |
| Vomiting | 0 | 1 (1.5) | 0 | 0 | 1 (5.6) | 0 |
| TEAEs reported by ≥5% in pooled PGZ groups | ||||||
| Nausea | 0 | 9 (13.4) | 1 (8.3) | 1 (4.8) | 5 (27.8) | 2 (12.5) |
| Diarrhea | 1 (5.6) | 7 (10.4) | 2 (16.7) | 1 (4.8) | 4 (22.2) | 0 |
| Injection site reaction | 0 | 6 (9.0) | 1 (8.3) | 2 (9.5) | 1 (5.6) | 2 (12.5) |
| COVID-19 | 3 (16.7) | 4 (6.0) | 0 | 3 (14.3) | 0 | 1 (6.3) |
| Injection site erythema | 0 | 4 (6.0) | 0 | 1 (4.8) | 2 (11.1) | 1 (6.3) |
| Injection site pruritus | 0 | 4 (6.0) | 1 (8.3) | 2 (9.5) | 1 (5.6) | 0 |
| Abdominal pain | 0 | 3 (4.5) | 0 | 0 | 2 (11.1) | 1 (6.3) |
COVID-19, coronavirus disease-19; TEAE, treatment-emergent adverse event; PGZ, pegozafermin.
Safety analysis set is defined as all participants who received at least one dose of investigational product. The safety analysis set is summarized based on planned treatment. Four participants randomized to receive 9 mg QW received 18 mg QW throughout the treatment; these four participants were categorized in the actual treatment group of 18 mg QW in safety analysis. Three participants randomized to receive 27 mg QW received 36 mg QW throughout the treatment; these three participants were categorized in the planned treatment group of 27 mg QW as it was the highest QW dose in the study.