TABLE 2.
Overview of toxicology studies with Mim8 in cynomolgus monkeys
| Study | Dose (mg/kg/week) | Administration route | n a | ADAs (neutralizing ADAs) b | Noteworthy adverse findings in single animals |
|---|---|---|---|---|---|
| 4‐week | 1 | SC | 2 | 0/2 (0/2) | ‐ |
| 4 | SC | 2 | 0/2 (0/2) | ‐ | |
| 20 | SC | 2 | 1/2 (0/2) | One microscopic pulmonary thrombus | |
| 60 | SC | 2 | 1/2 (0/2) | ‐ | |
| 20 | IV | 2 | 1/2 (0/2) | ‐ | |
| 13‐week | 0 c | SC | 6 | ‐ | ‐ |
| 6 c | SC | 6 | 5/6 (2/6) | Three microscopic pulmonary thrombi | |
| 12 c | SC | 6 | 3/6 (0/6) | Necrosis adrenal medulla | |
| 0 | SC | 6 | ‐ | ‐ | |
| 0.3 | SC | 6 | 0/6 (0/6) | ‐ | |
| 6 | SC | 6 | 6/6 (2/6) | Necrosis axial lymph node | |
| 12 | SC | 6 | 4/6 (2/6) | One microscopic thrombus | |
| 12 d | SC | 4 | 3/4 (1/4) | ‐ | |
| 1 e | IV | 6 | 5/6 (5/6) | ‐ | |
| 26‐week | 0 | SC | 8 | ‐ | ‐ |
| 0.3 | SC | 8 | 4/8 (4/8) | ||
| 1 | SC | 8 | 3/8 (3/8) | ‐ | |
| 3 | SC | 8 | 4/8 (4/8) | ‐ |
Abbreviations: ADAs, anti‐drug antibodies; IV, intravenous; SC, subcutaneous.
a
Equal numbers of male and female animals were used.
b
Neutralizing based on reduced exposure and reduced effect in thrombin generation assay/activated partial thromboplastin time at the end of the study.
c
Interim animals sacrificed after 4 weeks of dosing.
d
Animals dosed for 13 weeks followed by a 13‐week recovery phase.
e
Animals from IV group dosed for 8 weeks.
[Correction added on March 17, 2022, after first online publication: The heading for Table 2 has been updated.]