The Hare Is Catching the Tortoise
I recommend listening to Alnylam's HBV call from this afternoon if you still own some Tekmira. Alnylam is commencing its Phase I trials for ALNY-HBV by the end of the year. The drug is, of course, subQ, which give it a major advantage over TKM-HBV, although it only has 1 trigger, while TKM-HBV has 3. The Phase I trial of ALNY-HBV will have 3 components: SAD in healthy volunteers; SAD in chronically infected patients; and MAD with 12 weeks of dosing in chronically infected patients. Alnylam stated the Phase I will be completed by the end of 2016. From there they are moving it into Phase II combo studies. So it will be entering Phase II combo studies the same time TKM-HBV will be.
In the meantime, Tekmira started a Phase I, SAD trial of TKM-HBV in healthy volunteers nearly 8 months ago. This isn't that complicated of a study. Odd the results have not been released yet.