Nice SLC post: slcimmuno Member Level Sunday,
Post# of 72446
(Total Views: 1136)
Posted On: 05/21/2017 2:36:08 PM
Re: someconcerns #34004
Nice SLC post:
slcimmuno Member Level Sunday, 05/21/17 10:01:26 AM
Re: scottsmith post# 182710
Post # of 182745
IMO It's fair to say that Prurisol, in the 200mg, approximately matched Otezla (35% of patients saw a 2pt drop in IGA score) with the caveat said signal needs to be validated in the 189-patient powered Ph2b.
(So yeah - it's kind of like saying Bryce Harper is Babe Ruth, Mantle, Ted Williams etc ... at least not yet ... though he might win the award for best head-o-hair!)
Also recall the strongest P efficacy signal in Ph2 occurred in IGA 3 (moderate) group, at baseline, with 46% of those patients seeing at least a 2-pt improvement, an even more suggestive signal.
So as to the P2b (what to watch, what to potentially get excited about):
1. Patients: testing mod-to-sev not mild-to-mod so the efficacy should be higher if signal in the Ph2 was true
2. Dosing: The higher dosing levels, 300mg and 400mg, in theory, should yield a better efficacy result
3. Uptake: Recall it took Otezla 16 weeks to hit ~30% PASI 75 whereas P hit its IGA 0/1 scores at 12 weeks
4. Scale: PASI is being used not IGA, so we'll have a direct comparison... will clear up, definitively, the P / Otezla efficacy debate
5. Clear/Almost Clear: Otezla barely gets into PASI 90s, whereas P did hit 0/1 on IGA, so worth watching the PASI 90s/100s
Commented on this last week, but:
If P meet Otezla -- 30% PASI 75 but in less time (12 weeks not 16) -- we've got a winner. $1-3bn.
If P betters Otezla -- 40% PASI 75 in 12 weeks, and maybe sooner -- we've got a big winner. $3-5bn.
If P approaches biologics -- 50% PASI 75, with healthy PASI 90/100 -- we've got a Big Winner.
$5bn+.
And great thing is we'll know in 3 months or so with the interim, the 6-week readout, with hopefully additional trend-line data for patients further into their treatment.
If P betters Otezla, in less time, and approaches or compares favorably to some of the biologics (with less side effects, difficult administration, failure rates, high costs, etc) -- then P could generate those multiple Bn figures.
As to B IBD, I do think this is "partnerable" once the full data set is in. Biologics are not as impressive in IBD as they are in Pso. And Brilacidin UP/UPS have been impressive in a PofC way.
B-OM ... a Pharma might also move on this once more data is in. Breakthrough, if indeed it has been applied for and obtained, would be a CTIX catalyst for sure. B-through can be awarded earlier on and the FDA does allow for an expedited "preliminary" evaluation.
http://www.fdalawblog.net/fda_law_blog_hyman_...reque.html
https://www.brookings.edu/wp-content/uploads/...e-deck.pdf
Brilacidin, again my fave, in general -- what won't it eventually be able to be shown to do? Especially now that it's topical application, with little absorption, has been shown to yield impressive results. B the drug that will just keep on giving.
Kevetrin - needs more time but very interested in seeing what the OC trial tells is about its MOA.
So stay tuned, don't change the channel -- or lose focus on what has always been the driving CTIX narrative, at least for me: the blindingly good Science that may be reaching a big-time tipping point.
Next few months are going to get lots more interesting.
slcimmuno Member Level Sunday, 05/21/17 10:01:26 AM
Re: scottsmith post# 182710
Post # of 182745
IMO It's fair to say that Prurisol, in the 200mg, approximately matched Otezla (35% of patients saw a 2pt drop in IGA score) with the caveat said signal needs to be validated in the 189-patient powered Ph2b.
(So yeah - it's kind of like saying Bryce Harper is Babe Ruth, Mantle, Ted Williams etc ... at least not yet ... though he might win the award for best head-o-hair!)
Also recall the strongest P efficacy signal in Ph2 occurred in IGA 3 (moderate) group, at baseline, with 46% of those patients seeing at least a 2-pt improvement, an even more suggestive signal.
So as to the P2b (what to watch, what to potentially get excited about):
1. Patients: testing mod-to-sev not mild-to-mod so the efficacy should be higher if signal in the Ph2 was true
2. Dosing: The higher dosing levels, 300mg and 400mg, in theory, should yield a better efficacy result
3. Uptake: Recall it took Otezla 16 weeks to hit ~30% PASI 75 whereas P hit its IGA 0/1 scores at 12 weeks
4. Scale: PASI is being used not IGA, so we'll have a direct comparison... will clear up, definitively, the P / Otezla efficacy debate
5. Clear/Almost Clear: Otezla barely gets into PASI 90s, whereas P did hit 0/1 on IGA, so worth watching the PASI 90s/100s
Commented on this last week, but:
If P meet Otezla -- 30% PASI 75 but in less time (12 weeks not 16) -- we've got a winner. $1-3bn.
If P betters Otezla -- 40% PASI 75 in 12 weeks, and maybe sooner -- we've got a big winner. $3-5bn.
If P approaches biologics -- 50% PASI 75, with healthy PASI 90/100 -- we've got a Big Winner.
$5bn+.
And great thing is we'll know in 3 months or so with the interim, the 6-week readout, with hopefully additional trend-line data for patients further into their treatment.
If P betters Otezla, in less time, and approaches or compares favorably to some of the biologics (with less side effects, difficult administration, failure rates, high costs, etc) -- then P could generate those multiple Bn figures.
As to B IBD, I do think this is "partnerable" once the full data set is in. Biologics are not as impressive in IBD as they are in Pso. And Brilacidin UP/UPS have been impressive in a PofC way.
B-OM ... a Pharma might also move on this once more data is in. Breakthrough, if indeed it has been applied for and obtained, would be a CTIX catalyst for sure. B-through can be awarded earlier on and the FDA does allow for an expedited "preliminary" evaluation.
http://www.fdalawblog.net/fda_law_blog_hyman_...reque.html
https://www.brookings.edu/wp-content/uploads/...e-deck.pdf
Brilacidin, again my fave, in general -- what won't it eventually be able to be shown to do? Especially now that it's topical application, with little absorption, has been shown to yield impressive results. B the drug that will just keep on giving.
Kevetrin - needs more time but very interested in seeing what the OC trial tells is about its MOA.
So stay tuned, don't change the channel -- or lose focus on what has always been the driving CTIX narrative, at least for me: the blindingly good Science that may be reaching a big-time tipping point.
Next few months are going to get lots more interesting.
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