Amyndas Pharmaceuticals, which is committed to developing innovative therapeutics for complement-mediated conditions, today announced positive preliminary results from a Phase 1 clinical trial of its C3-targeted complement inhibitor, AMY-101. The phase I which has just been completed, was a prospective, single-center, open-label, First-In-Human (FIH) clinical study, designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after a Single Ascending Dose (SAD) and Multiple Doses (MD) of AMY-101 administered systemically (via the subcutaneous or intravenous route) in healthy male volunteers.
Preliminary analysis of the study results shows that AMY-101 was safe, well tolerated, and that AMY-101’s PK / PD profile can support a therapeutic schedule of efficient complement C3 inhibition, via subcutaneous administration every 48 hours.
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