Catalyst reported that Phase 1 topline data show vamorolone provides on-target glucocorticoid activity with no evidence of significant immunosuppression at clinical doses.
Key Highlights:
- Two-part Phase 1 in healthy adults assessed equipotency vs deflazacort and ascending vamorolone doses.
- Single-dose comparison (vamorolone 300 mg vs deflazacort 0.9 mg/kg) showed comparable cortisol suppression and similar onset.
- Vamorolone produced less pronounced immunosuppressive biomarker effects than deflazacort at clinical doses.
- Ascending-dose study (9, 27, 40 mg/kg daily x7 days) found clinically relevant immunosuppression only at 40 mg/kg/day, above approved dosing.
- Findings support potential for vamorolone to deliver anti-inflammatory benefit without clinically meaningful immunosuppression at therapeutic doses.
Original SEC Filing:
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