Company Update (NASDAQ:ARWR): Arrowhead Pharmaceuticals Inc Initiates Phase 1/2 Single and Multiple Dose Study of Hepatitis B Candidate ARC-521

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) announced that it initiated a Phase 1/2 study of ARC-521, the company’s second RNAi-based investigational medicine for the treatment of chronic hepatitis B virus (HBV) infection. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single doses of ARC-521 in healthy volunteers and the safety, tolerability, and antiviral activity of single and multiple doses of ARC-521 in patients with chronic HBV. This study may have multiple readouts, including single dose safety data, single dose antiviral activity data, and multiple dose safety and antiviral activity data.

Bruce Given, M.D., Arrowhead chief operating officer and head of R&D said, “Arrowhead is a clear leader in the search for curative therapies for chronic hepatitis B, which affects up to 350-400 million people worldwide. Designed to complement ARC-520, ARC-521 targets HBV mRNA transcripts from both cccDNA and integrated DNA and is expected to be most suitable for those patients who tend to have lower levels of viral cccDNA. We have moved very fast with this program, and we think ARC-521 increases our leadership position in the HBV space and the race to a functional cure. Our experience working with HBV investigators, key opinion leaders, and patients around the world has helped guide the design of an innovative first-in-man study for ARC-521 that is intended to get to multiple dose data in patients rapidly.”

The ARC-521 study (ARC5211001) is a multicenter, placebo-controlled, double-blind, dose escalation study of ARC-521 in healthy volunteers including a sequential, multiple dose, open label part in patients with chronic HBV. Normal healthy volunteers will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 or placebo. Chronic HBV patients that are negative for Hepatitis B e-antigen (HBeAg) at screening will enroll sequentially into 3 dose levels (8 patients per dose level) to receive 3 monthly doses of open label ARC-521. The study is currently recruiting at a single center in New Zealand and the company plans to add additional centers in other countries, pending regulatory and ethics review. (Original Source)

Shares of Arrowhead Research closed yesterday at $6.08, down $0.07 or -1.14%. ARWR has a 1-year high of $9.36 and a 1-year low of $3.07. The stock’s 50-day moving average is $5.78 and its 200-day moving average is $5.10.

On the ratings front, Jefferies Co. analyst Eun Yang reiterated a Hold rating on ARWR, with a price target of $4.75, in a report issued on May 11. The current price target implies a downside of 21.9% from current levels. According to, Yang has a yearly average return of -2.9%, a 59.6% success rate, and is ranked #3414 out of 3903 analysts.

Arrowhead Pharmaceuticals, Inc. engages as a biopharmaceutical company developing targeted RNAi therapeutics. Its pipeline includes clinical programs in chronic hepatitis B virus and partner based programs in obesity and oncology. 

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