ZGEN - Some summary comments on the Zymo data:
a) At 1.5 dosing shows 2/7 RVR rate in naive patients, 0/13 RVR in relapsers. And at 2.25 dosing for relapsers shows 1/6 RVR. Compared to PROVE/SPRINT data which shows 0/43 RVR in relapsers and 8-13 pct RVR in naive patients. Note that this is with an assay that is consistent with 'typical' now - an assay sensitive down to <25 IL/ml. (My statistical comment is the numbers are not stat sig compared to historical, but both the naive RVRs and the 2.25 relapser RVR are in the neighborhood of 0.05-0.10 using the xxxx Exact (can't remember his name - but the Exact which I consider substantially more realistic than Fisher's Exact.). Altogether I'd consider the efficacy moderately strong evidence of superiority over inf-a.
b) SAE - They still need to figure out protocol to deal with liver ALT issues (I'd expect a first cut of this to be worked out in the dosing arms of the Ph ii). As for pruritus, this is, apparently, a common side effect of inf-a/ribavirin (11-30% is the range I have seen in literature.). For the IFN-L/rib arms the numbers are 4/32 - so in the standard range for inf-a/rib.
c) If(!!) ifn-a has substantial number of dosing step downs after the first 4 weeks then I would expect even better comparison to SOC at EVR.
PS credit to dewo for much of this.
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