ARTICLE | Clinical News

Pharming reports Phase II data for Ruconest in HAE in pediatric patients

November 30, 2017 11:25 PM UTC

In September, Pharming Group N.V. (Euronext:PHARM) reported data from 20 patients ages 2-13 with hereditary angioedema (HAE) in a Phase II trial showing that 50 IU/kg IV Ruconest conestat alfa (rhC1INH) was safe and well tolerated, with no serious adverse events, hypersensitivity reactions or neutralizing antibodies reported. On secondary endpoints, the product had a median time to onset of relief of 60 minutes and a median time to minimal symptoms of 122 minutes.

The open-label, international trial is evaluating safety and immunogenicity as its primary endpoints. Secondary endpoints include time to beginning of relief, minimal symptoms and complete resolution, pharmacokinetics and pharmacodynamics...

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Pharming Group N.V.

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Complement 1 (C1) esterase