Arrowhead Pauses ARO-ENaC Phase 1/2 Clinical Study

 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today notified regulatory agencies, institutional review boards, and investigators that effective immediately it is voluntarily pausing AROENaC1001, a Phase 1/2 clinical study of ARO-ENaC, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with cystic fibrosis (CF), after receiving a preliminary update from an ongoing chronic toxicology study in rats that contained unexpected signals of local lung inflammation. The company has instructed investigators to pause new screening, enrollment, and any further dosing of investigational ARO-ENaC pending additional data from the ongoing chronic rat toxicology study and an additional ongoing chronic primate toxicology study.

Javier San Martin, M.D., chief medical officer at Arrowhead, said: "The safety of patients that participate in clinical trials of our investigational medicines is paramount to us at Arrowhead. While we have not seen any concerning safety or tolerability signals in subjects enrolled in the AROENaC1001 study, out of an abundance of caution we have decided to pause new screening, enrollment, and any further dosing of investigational ARO-ENaC in the study while we await additional information from ongoing nonclinical toxicology studies. After we receive the full data from these studies, we will assess whether there is an acceptable path forward for further clinical investigation. While we determine our next steps with ARO-ENaC, we look forward to continued progress with the other 8 clinical drug candidates in our pipeline as well as our rapidly expanding preclinical initiatives, including additional lung-targeted programs."

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