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Parion expands population criteria for CF trial
October 2015
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DURHAM, N.C.—Parion Sciences has expanded the enrollment criteria for its CLEAN-CF study of P-1037 from individuals with cystic fibrosis aged 18 and above to include individuals with cystic fibrosis between the ages of 12 and 17 years of age. This expansion is based on a prespecified safety review by the Data Monitoring Committee. The CLEAN-CF study is examining the potential of inhibiting the epithelial sodium channels in the airways with P-1037 (also known as VX-371), which is being developed in collaboration with Vertex Pharmaceuticals. This approach is thought to rehydrate the mucus layers, thereby improving airway clearance and potentially lung function. Preclinical models have shown P-1037 to be long-acting, and Phase 1 studies demonstrated the compound’s safety and tolerability profile. The launch of the Phase 2 trials was supported by an award from Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit affiliate of the Cystic Fibrosis Foundation.

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