Arrowhead Announces Interim Results from Ongoing Phase 1/2 Study of ARO-C3 for Treatment of Complement Mediated Diseases
- Achieved Mean Reductions of 88% in C3 and 91% in AH50
In Part 1 of AROC3-1001, ARO-C3 interim results included:
- A dose-dependent reduction in serum C3, with 88% mean reduction at highest dose tested
- A dose-dependent reduction in AH50, a marker of alternative complement pathway hemolytic activity, with 91% mean reduction at highest dose tested
- Duration of pharmacologic effect supportive of quarterly or less frequent subcutaneous dose administration
Safety and tolerability
- Overall, no clinically significant laboratory findings or patterns of adverse changes in any clinical laboratory parameters
- No dose limiting toxicity, serious or severe adverse events, or study discontinuation due to adverse events
- Most common adverse events include headache, COVID-19, generally mild injection site reactions, and seasonal allergy
“ARO-C3 has achieved encouraging results in Part 1 of this Phase 1/2 clinical study, including a mean reduction of 88% in C3 and 91% in AH50 at the highest dose tested. These data in healthy volunteers provide us with further confidence as we begin Part 2 of the study, which includes patients with various complement mediated diseases,” said
AROC3-1001 (NCT05083364) is a Phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3 in up to 42 adult healthy volunteers (Part 1), and up to 42 adult patients with paroxysmal nocturnal hemoglobinuria (PNH) or with complement-mediated renal disease (Part 2).
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