Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) shares made a solid gain on Tuesday after the company gave an update on its midstage study. Specifically, the firm announced that it has dosed the first subjects in a Phase 1/2 clinical study of ARO-HBV, which is being developed as a potentially curative therapy for patients with chronic hepatitis B virus (HBV) infection.
With this trial underway, Arrowhead stands to continue its incredible breakout. Excluding Tuesday’s move, Arrowhead has outperformed the broad markets, with its stock up over 270% in the past 52 weeks. In just 2018 alone, the stock is up nearly 90%.
What stands out here is that ARO-HBV is the second clinical candidate developed using Arrowhead’s proprietary Targeted RNAi Molecule technology.
This study is evaluating the safety, tolerability and pharmacokinetic effects of single-ascending doses of ARO-HBV in healthy adult volunteers and evaluating the safety, tolerability and pharmacodynamic effects of multiple-ascending doses of ARO-HBV in patients with chronic HBV.
Bruce Given, M.D., chief operating officer and head of R&D at Arrowhead, commented:
We are proud of how quickly ARO-HBV moved through preclinical studies and are excited to be starting first-in-human clinical studies. The AROHBV1001 Phase 1/2 clinical study has an innovative design that is intended to assess, in parallel, safety and tolerability in healthy volunteers and multiple-dose anti-viral activity in HBV patients. Our experience with two prior compounds, ARC-520 and ARC-521, provides us with confidence that ARO-HBV, which is designed to target all viral transcripts, including those produced by both cccDNA and HBV DNA integrated into host DNA, has the potential to be a backbone therapy in combinations aimed at achieving a functional cure of chronic HBV infection.
Shares of Arrowhead traded up 14% at $7.95 on Tuesday, with a consensus analyst price target of $5.50 and a 52-week range of $1.42 to $8.09.