Another sticky worthy post from slcimmuno:
Quote:
Good post. My 10c on Prurisol and Brilacidin vs Biologics, valuation / partnering scenarios.
Psoriasis--the biologics are rather impressive in how fast the uptake is - strong 70%+ PASI 75 (and higher) response w/in 6 weeks (steep efficacy slope)... but only for the 7 of 10 patients who respond (so our HLA B 5701 10-15% exclusion rate less bad in comparison) and recall biologics lose their efficacy over time (30% of those on treatment have to switch to another treatment)... though do have low placebo rates compared to active arms (<5%)
IBD--the biologics are much less impressive as compared to corticosteroids and other firstline meds... lower bar for B ... 20, 30, maybe 50% "Clinical Remission" response (variously defined, part of the problem in IBD: no one agreed upon efficacy measure, though endoscopic - mucosal - remission increasingly important) and high placebo rate (10-20%)
The biologics also have the downside of onerous delivery and an unsavory side effects profile and are very very very (the most) costly of mess = 10% of all Rx costs/spending in U.S., ie, Pharmacy Benefits Comps would luv a less spendy alternative on the formulary
Advantage of P - oral, established safety profile (tied to Ziagen), likely to be m less costly (to mgd care comp delight), 505b2 abbreviated path (maybe only 1 phase 3 required). If we use Otezla as comparator then if P can deliver a 30% PASI 75 at 6 weeks (interim, Q3 2017) we'd have hit a wave-to-the-crowd stand off home run. Think "a drug as good as Apremilast but acting in half the time" -- Otezla gets to 30% PASI 75 at 16 weeks. By end of study, if we get into ~50% PASI 75 in 6-8, even 10 weeks, and pick up some PASI 90s-100s, then Game Over imo. Think "a drug twice as good as Otezla but acting in half the time." Someone will pay up and prob fast, as in the Billions (~5bn)
Advantage of B - OM: already granted Fast Track (Breakthrough next?) based on interim showing Prevention of Severe OM (70% P vs 22% placebo) ie, not just Alleviation of symptoms like Soligenix... looking like might be only game in town, for the 450k patients in the U.S. / should the trial close out with similar numbers then odds are good a Big Rx will offer to buy/partner (1bn?)
Advantage of B - IBD - too early to do an apples apples comparison: only 18 patients PofC trial, not full UC just distant and enema formulation not ideal... but Signal seems strong -- 50% full clinical MMDAI remission with partial MMDAI remission for the others (11 of 12 patients if I recall). Plus the sub score Endoscopy data was strong (7 of 11 patients) - mucosal healing not just reliant upon subjective scoring. Am sure the pics and vids (scopes) CTIX say they are taking might help reinforce potential to inquiring pocketbooks. I see a B IBD Deal ~100-200m upfront but a healthy backend (Bio Bucks) only because data not as mature and formulation not there yet.
My dream scenario by end 2017
PRURISOL
interim: 30-40% PASI 75 in 6 weeks
topline: 50% PASI 75 in 8-10, even 12 weeks
valuation: 3-$5bn valuation (sell to Big Rx)
BRILACIDIN
Don't sell... maximal value not yet supported by the most robust data set. Partner entire platform w Best Big Rx (most generous, best synergy, product overlap, expertise) to come up with oral and topical formulations to blow lids of B IBD and B Derm across the next 2 years ... run multiple powered Phase 2 trials across numerous indications...
KEVETRIN
Pour $ from P and B into K (not sure its far enough along at moment to Partner) nailing oral formulation then running multiple phase 2s, mono and combo therapies, in Ovarian, Pancreatic, AML, etc... the at least 50% of cancers affected by P53 mutations... establish the Data then partner or sell
Outside chance a Rx will want to take CTIX out early rather than Pay Up More later
Anyhoo - if one believes in the Science and can avoid the FUD, December 2017 (and beyond) has the potential of being momentous (wink)
Quote:
Good post. My 10c on Prurisol and Brilacidin vs Biologics, valuation / partnering scenarios.
Psoriasis--the biologics are rather impressive in how fast the uptake is - strong 70%+ PASI 75 (and higher) response w/in 6 weeks (steep efficacy slope)... but only for the 7 of 10 patients who respond (so our HLA B 5701 10-15% exclusion rate less bad in comparison) and recall biologics lose their efficacy over time (30% of those on treatment have to switch to another treatment)... though do have low placebo rates compared to active arms (<5%)
IBD--the biologics are much less impressive as compared to corticosteroids and other firstline meds... lower bar for B ... 20, 30, maybe 50% "Clinical Remission" response (variously defined, part of the problem in IBD: no one agreed upon efficacy measure, though endoscopic - mucosal - remission increasingly important) and high placebo rate (10-20%)
The biologics also have the downside of onerous delivery and an unsavory side effects profile and are very very very (the most) costly of mess = 10% of all Rx costs/spending in U.S., ie, Pharmacy Benefits Comps would luv a less spendy alternative on the formulary
Advantage of P - oral, established safety profile (tied to Ziagen), likely to be m less costly (to mgd care comp delight), 505b2 abbreviated path (maybe only 1 phase 3 required). If we use Otezla as comparator then if P can deliver a 30% PASI 75 at 6 weeks (interim, Q3 2017) we'd have hit a wave-to-the-crowd stand off home run. Think "a drug as good as Apremilast but acting in half the time" -- Otezla gets to 30% PASI 75 at 16 weeks. By end of study, if we get into ~50% PASI 75 in 6-8, even 10 weeks, and pick up some PASI 90s-100s, then Game Over imo. Think "a drug twice as good as Otezla but acting in half the time." Someone will pay up and prob fast, as in the Billions (~5bn)
Advantage of B - OM: already granted Fast Track (Breakthrough next?) based on interim showing Prevention of Severe OM (70% P vs 22% placebo) ie, not just Alleviation of symptoms like Soligenix... looking like might be only game in town, for the 450k patients in the U.S. / should the trial close out with similar numbers then odds are good a Big Rx will offer to buy/partner (1bn?)
Advantage of B - IBD - too early to do an apples apples comparison: only 18 patients PofC trial, not full UC just distant and enema formulation not ideal... but Signal seems strong -- 50% full clinical MMDAI remission with partial MMDAI remission for the others (11 of 12 patients if I recall). Plus the sub score Endoscopy data was strong (7 of 11 patients) - mucosal healing not just reliant upon subjective scoring. Am sure the pics and vids (scopes) CTIX say they are taking might help reinforce potential to inquiring pocketbooks. I see a B IBD Deal ~100-200m upfront but a healthy backend (Bio Bucks) only because data not as mature and formulation not there yet.
My dream scenario by end 2017
PRURISOL
interim: 30-40% PASI 75 in 6 weeks
topline: 50% PASI 75 in 8-10, even 12 weeks
valuation: 3-$5bn valuation (sell to Big Rx)
BRILACIDIN
Don't sell... maximal value not yet supported by the most robust data set. Partner entire platform w Best Big Rx (most generous, best synergy, product overlap, expertise) to come up with oral and topical formulations to blow lids of B IBD and B Derm across the next 2 years ... run multiple powered Phase 2 trials across numerous indications...
KEVETRIN
Pour $ from P and B into K (not sure its far enough along at moment to Partner) nailing oral formulation then running multiple phase 2s, mono and combo therapies, in Ovarian, Pancreatic, AML, etc... the at least 50% of cancers affected by P53 mutations... establish the Data then partner or sell
Outside chance a Rx will want to take CTIX out early rather than Pay Up More later
Anyhoo - if one believes in the Science and can avoid the FUD, December 2017 (and beyond) has the potential of being momentous (wink)
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