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Re: DewDiligence post# 228343

Wednesday, 04/15/2020 6:32:24 PM

Wednesday, April 15, 2020 6:32:24 PM

Post# of 250008
VIR reports interim phase-2 data in HBV:

Vir Biotechnology today announced additional interim data from the ongoing Phase 2 trial… of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi) for the treatment of chronic hepatitis B virus (HBV) infection.

…In the ongoing Phase 2 trial, virally suppressed patients on nucleos(t)ide reverse transcriptase inhibitor therapy (n=24) received two subcutaneous 20, 50, 100, or 200 mg doses of VIR-2218 on Day 1 and Day 29. At Week 24, the mean change in HBsAg observed with 20, 50, 100, and 200 mg was -0.76 log10, -0.93 log10, -1.23 log10, and -1.43 log10, respectively [a nice dose response].

Of note, all patients who received the 200 mg dose level achieved a >=1 log10 reduction in HBsAg, with HBeAg- and HBeAg+ patients achieving similar mean declines. There has been no dose-related trend in the frequency of AEs observed during the trial, with the most common AE being headache (n=6; 25%). No patients discontinued the trial due to an AE.

…“Our next step will be to demonstrate whether knockdown of HbsAg can result in high rates of functional cure when VIR-2218 is given in combination with other agents, which is the goal of our next set of trials. We expect the first of those combination trials—combining VIR-2218 with a shortened course of pegylated interferon—to begin dosing patients in the second half of this year.”

VIR-2218 incorporates ALNY’s ESC+ siRNA technology, which VIR claims is a differentiating factor for VIR-2218 compared to other RNAi-based programs in HBV.

CC slides for the above data:

VIR is flattish in AH trading, but this doesn’t mean much vis-à-vis the HBV data presented above; lately, VIR has been trading as a COVID-19 play.

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