Findings from the study, dubbed PROLASTIN-C SPARK, demonstrated that weekly infusions of PROLASTIN-C at 120 mg/kg increased serum concentrations of the A1PI protein to proportionately higher levels than weekly infusions of 60 mg/kg, the currently approved dose of PROLASTIN-C. In addition, the 120 mg/kg dose boosted serum concentrations of A1PI to the range of 20-53 micromolar, considered to be normal for healthy individuals. Both doses were safe and well tolerated in patients with AAT deficiency.
Grifols said that it will use these data to start a larger, long-term clinical trial of the two doses of PROLASTIN-C. The study is expected to commence in the second half of the year.
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