SLC post re Prurisol...
slcimmuno Member Level Saturday, 05/13/17 06:58:27 PM
Re: cabel post# 181840
Post # of 181920
Good input. The trial obviously is taking longer than expected - based on competing trials, according to the company. Adding sites should help expedite (a bigger net).
If we get Interim by August/September, I'm okay with that. Only 3-4 months away. The Brilacidin UPS PofC will have been completed by then (Q2) and perhaps we'll get more insight into B OM, though I have a sense that trial is gonna take a bit longer (strict criteria). So there will be other results to chew on.
Regarding interim--yes, I think the plan is to take a snapshot when all patients hit 6 weeks... to change it, they'd have to file an amendment w FDA. Even with the 6-week trigger, that shouldn't prevent CTIX from looking at the trend lines of patients deeper into treatment, ie, those who might be 8, 10, even 12 weeks. Hopefully we get a picture of the PASI trends beyond 6 weeks for the patients farther along on the P 300mg and 400mg arms.
Again, I'm hoping we see 40-50% PASI 75 by trial end (25-30% still a Win) with a faster uptake -- maybe by 8, 10 weeks... though if it takes 12 weeks, no worries. Since we're increasing dose by 50% and 100%, and with P as dose-dependent, the efficacy curve has a good chance of steepening. The aggregate 12 week PASI numbers could even be higher, healthy PASI 90/100 scores, as 46% of moderate PsO patients in the P2 saw a 2-pt drop, to IGA 0/1, which is closer to PASI 90 than PASI 75 if you're comparing them.
See:
"The 5-point Investigator’s Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials"
http://www.tandfonline.com/doi/full/10.3109/0...013.865009
Anyway, to be an oral med twice as efficacious as $1-2bn year Apremilast, in one-half or two-thirds the time, and with an established safety profile, would be an incredible result, with Big Rx bidders likely lining up.
If we encroach on the biologics, then, well then, Prurisol will be taken out for Big Big Bucks.
slcimmuno Member Level Saturday, 05/13/17 06:58:27 PM
Re: cabel post# 181840
Post # of 181920
Good input. The trial obviously is taking longer than expected - based on competing trials, according to the company. Adding sites should help expedite (a bigger net).
If we get Interim by August/September, I'm okay with that. Only 3-4 months away. The Brilacidin UPS PofC will have been completed by then (Q2) and perhaps we'll get more insight into B OM, though I have a sense that trial is gonna take a bit longer (strict criteria). So there will be other results to chew on.
Regarding interim--yes, I think the plan is to take a snapshot when all patients hit 6 weeks... to change it, they'd have to file an amendment w FDA. Even with the 6-week trigger, that shouldn't prevent CTIX from looking at the trend lines of patients deeper into treatment, ie, those who might be 8, 10, even 12 weeks. Hopefully we get a picture of the PASI trends beyond 6 weeks for the patients farther along on the P 300mg and 400mg arms.
Again, I'm hoping we see 40-50% PASI 75 by trial end (25-30% still a Win) with a faster uptake -- maybe by 8, 10 weeks... though if it takes 12 weeks, no worries. Since we're increasing dose by 50% and 100%, and with P as dose-dependent, the efficacy curve has a good chance of steepening. The aggregate 12 week PASI numbers could even be higher, healthy PASI 90/100 scores, as 46% of moderate PsO patients in the P2 saw a 2-pt drop, to IGA 0/1, which is closer to PASI 90 than PASI 75 if you're comparing them.
See:
"The 5-point Investigator’s Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials"
http://www.tandfonline.com/doi/full/10.3109/0...013.865009
Anyway, to be an oral med twice as efficacious as $1-2bn year Apremilast, in one-half or two-thirds the time, and with an established safety profile, would be an incredible result, with Big Rx bidders likely lining up.
If we encroach on the biologics, then, well then, Prurisol will be taken out for Big Big Bucks.
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