Biotech Values

[dewophile]

final data from the GSK phase 2b trial was published in conjunction w the abstract presentation. There isn't a whole lot to add to the top line data that were in the body of the abstract but a few selected excerpts:

https://www.nejm.org/doi/full/10.1056/NEJMoa2210027

In group 1, a total of 16% of the participants receiving NA therapy and 25% of those not receiving NA therapy with a low HBsAg level (≤3 log10 IU per milliliter) at baseline had a primary-outcome event, as compared with 6% and 7% of participants, respectively, with a high HBsAg level (>3 log10 IU per milliliter) at baseline

GSK said they are moving forward with a phase 3 monotherapy study in H1 2023. I have to think it will be focused on this subset with higher efficacy. I'm not sure how large a market they will capture but given the enormous size of the overall market they must think some patients will take 6 months of weekly shots for a 1 in 6 chance of a functional cure. If it were me I would probably hold out a bit hoping a more efficacious (likely combination) regimen became available, but it is not entirely crazy considering the remaining risk of HCC even with Nuke therapy. I have no idea if the FDA has already signed off on a phase 3 w fairly weak efficacy

Of the participants who had a primary-outcome event, 7 (50%) receiving NA therapy and 6 (50%) not receiving NA therapy had anti-HBs at the end of the trial

This is lower than I expected and I am not surprised GSK didn't mention this in their press release. The lower seroconversion rate vs say interferon might make these patients more at risk of reversion post week 24 than you see w interferon, but hopefully this is not the case

I think this got a NEJM publication because you have a novel treatment that can get you "cures" w shorter duration of therapy and better tolerability than interferon. I also think so far Bepi is more promising than any of the siRNA drugs (and other ASOs) to date, and the authors seem to agree

Clinical trials with siRNAs have shown HBsAg reduction to less than 100 IU per milliliter in up to 70% of participants, but no, or very few, participants had HBsAg loss