Targeted Genetics' tgAAVCF Trial in CF Does Not Meet Primary Endpoint
Targeted Genetics has reported that its Phase II clinical trial of tgAAVCF in patients with mild-to-moderate cystic fibrosis (CF) failed to meet its primary endpoint of statistically significant improvement in lung function, 30 days following initial administration of tgAAVCF compared to placebo.
Based on these results, the company has decided not to pursue further development of tgAAVCF.
This study was partially funded by Cystic Fibrosis Foundation Therapeutics (CFFT), the drug discovery and development affiliate of the Cystic Fibrosis Foundation, and was being conducted through CFFT's Therapeutics Development Network.
The primary endpoint of the 102-patient trial was an improvement in FEV1 lung function 30 days following initial administration of tgAAVCF. The study also evaluated improvement in lung function at Day 90, which was 60 days following the administration of a second dose of tgAAVCF, and monitored the safety and tolerability profile of tgAAVCF.
The company expects to present the complete data set from the study in a peer-reviewed forum later this year. The company will continue to collect safety data through the end of the study.