ARC-520 2a results very encouraging

[Seattledude]

If things continue to plan this could hit the market by 2016

Best part of the results was the 1 log knockdown with 8week staying power and no sides. ARC-520 along with Tenofovir and a short duration of Peg may be able to provide seroconversion regardless of baseline hbsag.

This may be the most significant treatment development in the history of hbv

[Seattledude]

Here is the link to the conference call from today, including questions.

Phase 2b will begin end of 14 early 15 with endpoint of hbsag elimination with or without hbsag seroconversion

http://edge.media-server.com/m/p/wvj575tn/?token=us5y98hhnggnuez6v994nldwqw2ef651r48mlljja1qrjgj22406124

[melcul]

So encouraging ! If this works without any combo then a quick release i guess its very possible as they will earn all the money

[luckyman316]

I think their goal was to try to get this to work without any other drugs/combo therapy. I'm uncertain though, as I have not read the wording. I would imagine it will work without PEG... something many patients probably want to get away from. Hopefully there are no flare ups after cured or seroconversions from this phase. That's what concerns me the most, the long term and whether it will stick. We shall see in a year!

[Seattledude]

When I read the RBC note and knowing what we do about HBV, I was struck by points 2 and 3 in their analysis. Could ARC-520 work without PEG?

The fact that HBSAG continues to decline at 8 weeks and after only one dose opens the door to that possibility

Also does the rapid liver deterioration in HDV and it's potential as an orphan and fast tract status, allow for acceleration of use in HDV and maybe even advanced cases of HBV?

[Seattledude]

Here is the analysis of the results from RBC, keep in mind this is written from an investment prospective

ARWR reported initial top-line Phase IIa data that shows good knockdown of s-antigen, good durability, and good safety. We think they could get even better knockdown with higher doses and more duration and like how ARWR keeps going to higher doses. We expect the stock to trade up on this news as this shows the drug is working, hitting its target, and safety is good. Docs say that knocking down s-antigen with more doses, and more time, could lead to higher cures in Hep B and much higher than current therapy so this is fundamentally positive.

1. Overall s-antigen drop is "similar to non-human primate" studies which implies for investors around -0.8 log reduction

2. The duration of drop appears to be MUCH longer than expected including 2mg arm still demonstrating knockdown after 8 weeks (2 months)

3. The 2mg dose appears to have pts continuing to decline even at 8 weeks.

4. Safety appears fine no notable issues. No serious adverse events and no dropouts.

5. Third cohort (3mg/kg) opened and dosed w/ no difference in safety (ie that's good) and no increased frequency of Aes. Will also begin another cohort of 3mg. Less

[luckyman316]

Agreed, so much good news! Hitting the market by 2016 would be great and this is what I was hoping to hear. I know their goal was by 2015 so they may speed this up as quick as they can. Hopefully, a good open phase will be available to all next year and we can participate in the "studies" in the final phase. Keep praying, all, for a speedy cure!