Replies to post #191181 on Biotech Values

[poorgradstudent]

GLPG:

Since male is much smaller RA population (20-25%), it wouldn't be much different from other dose reduction implemented under different circumstances, for example renal impairment to use 2mg QD for baricitinib and 5mg QD for tofacitinib.

I agree that you can dose differently, and I appreciated your comment on twitter.

My only comment is that if the efficacy tracks as Darwin1/2 have, there is an incentive to be able to dose participants at 200 mg total per day. It's anecdotal in a sense, but in Darwin1 the only doses that reached statistical significance over placebo for ACR20 were the 200 mg once daily and 100 mg twice daily doses.

I don't make too much about ACR20 when you have ACR50/70, but it's still an oft-used primary endpoint in RA trials. I would think GLPG would prefer to dose as many participants as possible at levels above 100 mg/day.

[DewDiligence]

GLPG—…it wouldn't be much different from other dose reduction implemented under different circumstances, for example renal impairment…

Seems like it would be a tough detail for sales reps if not resolved. Docs are used to special dosing for renal impairment, but different dosing for the two sexes is much less common.

If the contraception requirement is not removed, that too would be a commercial hindrance.