Replies to post #204210 on Biotech Values

[dangerM]

> 25mg QD in the phase 2 you linked, not 50 qod

correct! I meant the completed ph 2a with 50mg qod, ph 2b will have 25mg qd.

I first wondered whether they wanted to have the Achillion compound removed from half of the tablets to save on licensing costs. However, they probably only had 50mg available and the pharmacokinetics came too much as a surprise to produce 25mg tablets.

Cf. the abstract* "Consistent with prior studies, increasing AL-335 dose from 400 to 800 mg increased ALS-022227 (parent nucleoside of AL-335) exposure less than proportionally. Observed ODV and SMV exposures in Cohort 1 were higher than anticipated. Reducing ODV dosing from QD to QOD decreased ODV exposure proportionally. Reducing SMV dosing from 100mg to 75mg QD decreased SMV exposure less than proportionally."

*no 178 "Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection." to be retrieved via
https://events.easl.eu/EventPortal/Information/EventProgramme.aspx?EventInformationPageCode=ONLINE%20PROGRAMME&EventCode=SP2016