Advertisement Pharming Phase III Ruconest study reaches full recruitment - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Pharming Phase III Ruconest study reaches full recruitment

Pharming Group has finished patient recruitment in Phase III study of investigational drug Ruconest (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema.

The company has randomised 75 patients with Hereditary Angioedema (HAE) in its ongoing US pivotal Study 1310, out of which 53 experienced a repeat attack or achieved a 90 day attack free period till now.

The study will continue till either all of the treated patients have received an open label treatment for a subsequent HAE attack, or until 90 days have lapsed since their randomised attack, which will be followed by data analysis.

Pharming COO Bruno Giannetti said the final step to completion of the trial consists of an additional follow up period of up to 90 days, depending on when patients experience a subsequent attack.

"However, it is a generally accepted assumption that approximately one to two attacks occur per month in otherwise untreated HAE patients, suggesting that those individuals in our study may typically experience a subsequent attack significantly sooner than 90 days post their randomized attack," Giannetti added.

The positive results from the study will generate a $10m milestone payment to Pharming from its US partner Santarus.