Biotech Values

[LongRun8]

Re JNJ-3989 and JNJ-6379

JNJ-3989 is monthly subcutaneous injections with a lot longer dosing regimen (48 weeks) vs. ENTA's oral formulation, which will likely be much shorter than that. In mice, ENTA used EDP-514 for 12 weeks, achieving max 4 log reduction in HBV viral titers. In humans, EDP-514 was used for 28 days, achieving HBV RNA 2.3 log reduction in HBeAg- patients and HBV RNA 2.8 log reduction in HBeAg+ patients. I'm not sure how long ENTA will end up dosing patients with EDP-514 in the long run, though, but presumably much shorter than 48 weeks.

JNJ-3989 200mg showed a mean reduction of HBsAg of 2.6 log, whereas ENTA's small molecule HBV RNA destabilizer, EDP-721, showed a max reduction of HBsAg of 3 log. Granted, JNJ had a larger study. Notably, though, EDP-721 is ENTA's add-on drug, not even their main drug EDP-514; and EDP-721 might end up being as good or better than JNJ-3989.

Interestingly, JNJ-3989 200mg + JNJ-6379 combo didn't seem to do as well JNJ-3989 200mg. I found that odd.

Also, no patient in the active treatment arms achieved functional cure at follow-up Week 24.

I am really excited to see the data as it progresses for EDP-514 and EDP-721, especially when they are combined together with a nuc.