Vabysmo (faricimab): how was the first human dose set?

Atlas/Bispecific antibodies/Vabysmo/First dose

Vabysmo: how was the first human dose set?

faricimab · VEGF-A x Ang-2

First-in-human starting dose

Starting dose 0.5 mg/eye IVT supported by monkey tox data (6 mg/eye high dose not initially supported; dose escalation gated)

“The proposed clinical starting dose of 0.5 mg/eye is supported by the nonclinical data but the high dose of 6.0 mg/eye is not.”

✓ VerifiedFDA pharmacology/toxicology review, p. 26Source ↗

NOAEL / key findings

Ocular NOAEL 0.5 mg/eye (ADA-linked ocular inflammation at ≥1.5 mg/eye); systemic NOAEL 1.5 mg/eye; heart squamous cyst/plaque at high dose

“For ocular toxicity, the NOAEL was 0.5 mg/eye (the low dose). The LOAEL was 1.5 mg/eye (the mid-dose), due to ocular inflammation (observed by ophthalmology and confirmed by histopathology).”

✓ VerifiedFDA pharmacology/toxicology review, p. 28Source ↗

Summary across all 18 bispecifics →

Vabysmo: how was the first human dose set?

Same question, other bispecifics

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