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Expert Interview

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Discussing the Potential of Arrowhead Pharma's (ARWR) ARC-520 in Treatment of Hepatitis-B After Positive Phase 1 Results

Ticker(s): ARWR, BMY

Who's the expert?

Name: Dr Paul Gaglio - MD

Institution: Columbia University

  • Director of Hepatology Outreach at NY Presbyterian Hospital, Columbia University Medical Center and former medical director of Adult Liver Transplantation at The Montefiore Medical Center
  • Has published multiple manuscripts, book chapters, and abstracts, and has participated in numerous research trials related to the therapy of hepatitis B and C, liver transplantation, and treatment of liver failure.
  • Fellow of the American College of Physicians, the American Gastroenterological Association, and the American Association for the Study of Liver Diseases.

Interview Questions

Can you describe your experience treating patients with Hepatitis-B? How many patients do you see in your practice, and what is the typical method for treating them? 

Added By: pjloria

Can you discuss the recent Phase I that showed ARC-520 and BMY's entecavir achieved up to 5.5 log (99.9997%) knockdown of HBV DNA in hepatitis B e-antigen (HBeAg)-positive treatment-naive patients, achieving reductions below the level of quantitation? What percentage of Hep-B patients are in this patient population? 

Added By: pjloria

ARC-520 inhibited HBV cccDNA--derived mRNA with observed viral protein reduction in HBV patients up to 2.0 log (99%) after a single dose. Can you discuss the clinical relevance of this result?

Added By: pjloria

Given the current information, how would you compare ARC-520 in terms of safety and efficacy to existing therapies? 

Added By: pjloria

Please comment on the relevance of an HBsAg Clearance Profile (CP) as a predictive biomarker of seroconversion. The theory being that therapy-induced (e.g., TDF and ARC-520) changes in HBsAg epitopes correlate with functional cures (Locarini, et al).

Added By: fatsammy123

Can you please scale this market to the HCV market? Both in terms of drug price, launch curve and peak sales?

Added By: joe_mccann

What is your view of Gilead's potential impact on chronic Hep B with defovir dipivoxil.  Phase II results looked promising.  Are there any other drugs in clinical trials currently that look promising and would compete with Arrowhead.

Added By: william gerber

If ARC-520 were to continue to demonstrate safety and efficacy and receive approval, what percentage of existing patients do you think would switch to ARC-520? How many new patients do you think would choose ARC-520 as their first-line treatment? 

Added By: pjloria

In their most recent earnings call, the company states that “ARC-521 is designed to hit mRNA transcripts deriving from both HBV cccDNA, and integrated HBV DNA. This means ARC-520 may be optimal in patient populations with higher levels of cccDNA, such as e-antigen positive NUC naive patients. And ARC-521 may be optimal in patients with lower levels of cccDNA.” What are your thoughts on this statement?

Added By: pjloria

Given the current information, how do you view ARC-520's chances of successfully moving through the later stages of testing and eventually receiving approval, or is it too early to tell? 

Added By: pjloria

Can you discuss any other data that has been released on ARC-520 and its implications for your patients?

Added By: pjloria

The current treatment (interferon) success rate at achieving functional cure is usually cited as ca 10%. What improvement over this number would constitute a meaningful medical advance (and therefore market opportunity), in your opinion? (assuming that any adverse effects are inconsequential)

Added By: user7867cb9b

Although it has yet to reach clinical trials, can you discuss the mechanism of action for ARC-521 and any data you are aware of at this point? Is there anything else we should know about ARC-521?

Added By: pjloria

By sufficiently knocking down production of immune suppressive antigens with ARC-520/521/entecavir, could administering a TLR agonist HBV vaccine (DVAX) be effective, at some point before complete viral clearance, to provide a 'boost' in helping to restore/reconstitute immune system response to HBV infection?  Are there other factors associated with HBV infection besides HBsAg thought to be important in immune system suppression?

Added By: delprice

I beleive that ARC-520 is composed of two molecules, a targeting molecule and the payload molecule.  It seems that both would need to be brought into the cell in sufficient quantities to be effective.  Are there sufficient molecules injected so that every liver cell would likely get enought?  How much more effective might the drug be if it were composed of one molecule?

Added By: userab5bc35d

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