Phase IIb trial for ARC-520 has been put on clinical hold by the FDA

[chihep]

http://www.in-pharmatechnologist.com/Drug-Delivery/Primate-deaths-cause-stock-plummet-for-Arrowhead-as-RNAi-PhII-trials-halted-by-FDA

Arrowhead Pharmaceuticals' Phase IIb trial for ARC-520, a drug candidate intended to treat hepatitis B infection, has been put on clinical hold by the FDA after several primates died in a toxicology study in which the drug was administered using EX1, a synthetic delivery vehicle. The firm said the cause of the primates' deaths is still under investigation.
InPharm.com (11/18)  

[Aduiski]

I pulled out of their latest trial at the very beginning when I noticed inconsistencies (what raised suspicions of dishonesty) in the documents I was provided by them....knowing that there is anyway only very tiny chance of the cure.

Their clinical trial news/announcements were always misleadingly worded...

Even their very latest announcement from few days ago is in line with this.....they state that they are abandoning further research in their current Hep B medicines  because it would be too expensive to examine those deaths...

Just read that the investors are preparing to sue them...

[Royal36]

Is our only hope now is from Replicor Inc & time estimates to deliver their drug to the market ? It is sad that we have left with some few options.

[sorte]

I wonder too, if there is any other promising drug in the development except Replicor ones ?

[sorte]

https://www.benzinga.com/analyst-ratings/analyst-color/16/11/8752732/alnylam-is-now-the-leader-in-the-clinical-hbv-rnai-thera ?

[needadvicewithhep]

I think hold the most promise... But there is so many things that have had potential ie Birinapant but as soon as there is  a set back investors get worried their money will end up down the toilet. Which is understandable. But that doesn't offer any comfort to someone with HBV....  There is things in the pipe line and I think with Replicors data it puts pressure on other bigger pharmas with bigger pockets to start getting their *** in gear and try to make progress.

Also Arrowhead did not say they have completely dumped ARC520

[needadvicewithhep]

Meant to write *Replicor hold the most promise

[Royal36]

66% already down today and now tax time coming major sell off. They should have waited a lit bit to protect the money.

[StephenCastlecrag]

ARC520 and ARC521 have now been abandoned by Arrowhead that said it will continue with RNAi against HBV using a different delivery platform SubQ. This is a major setback and definitely a big drag on development time.

[studyforhope]

Very bad news indeed. The big problem with delivering RNA into hepatocytes was always how to transfer them into the cytosol. The coinjection of mellitin, a bee venom that destabilized endosomes that have picked up IRNA bonded to a liver attracted carrier seemed always risky to me. A fundamental disruption of basic cellular physiology.
Hopefully they will have something less toxic and still effective before money runs out as was the case with tetralogic.

[StephenCastlecrag]

Technical merit aside, I think the biggest blow is loss of confidence, not just in the company, but also generally. Arrowhead did raise a lot of attention because of its avowed focus on getting a cure for HBV, so its rather rapid rise and fall is a big disappointment.