Arrowhead Pharmaceuticals (NASDAQ: ARWR) has announced that it is pausing its Phase 1/2 clinical study of ARO-ENaC, an RNAi therapeutic being developed as a treatment for patients with cystic fibrosis, after unexpected signals of local lung inflammation were seen in a separate chronic toxicology study in rats. The clinical study will be paused pending additional data from the ongoing rat toxicology study as well as from an ongoing chronic primate toxicology study.
ARWR’s market cap subsequently fell by over 25%.
ARO-ENaC utilizes Arrowhead’s proprietary TRiM platform and is the company’s first inhaled RNAi candidate to target pulmonary epithelium. ARO-ENaC directly binds a targeting αvβ6 ligand to the siRNA.
Drug candidates utilizing the TRiM platform do not an active endosomal escape component, like the company’s previous drug candidates.
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