AbbVie paid Boehringer $595 million upfront to license rights to risankizumab in early 2016, and this morning the company displayed a late-stage dataset on psoriasis explaining why they wanted this drug so badly, staying on track to creating a new franchise player the pharma company believes can register $4 billion to $5 billion in peak annual sales.
In a Phase III double header, researchers pitted the drug against two key — though fading — last-generation mainstays in the field, Stelara (ustekinumab) and its own mega-drug Humira (adalimumab). Their top prospect came through on all scores, outpacing the other two in clearing psoriasis while the placebo arm comparison numbers barely budged.
PASI 90 — a 90% clearance rate — came in at 75% twice and 72% for their 150 mg dose, compared to a set of rival drug responses ranging in the 40s. At one year, 56% and 60% of risankizumab patients achieved complete skin clearance (PASI 100) compared to Stelara.
Across all three trials, all primary and ranked secondary endpoints achieved p-values of <0.001.
“In this trial, 4 out of 5 patients achieved clear or almost clear skin with risankizumab at week 16. High levels of skin clearance, PASI 90, were also seen at week 44 for patients who received risankizumab, with a 12-week dosing regimen,” said principal investigator Kristian Reich.
Of course, AbbVie, like the other developers out to make a mark in this blockbuster field, are going against some soft targets. Novartis just rolled out impressive 5-year followup data on Cosentyx, the first of the new-wave drugs to hit the market. Since Novartis elbowed into the market, Eli Lilly has begun fielding Taltz, Valeant is pushing the troubled Siliq and J&J bagged a key FDA win in July for its own blockbuster IL-23 contender guselkumab.
Guselkumab slapped aside Humira, with J&J’s drug achieving an IGA 0/1 score of 84% versus 67.7% and a PASI 90 of 70% compared to 46.8%, respectively.
In one assessment of sales potential, Guselkumab registered a peak sales forecast of $1.6 billion, which also helps illustrate the opportunities here.
AbbVie’s drug blocks IL-23 by binding to its p19 subunit, and like the other big players in this field, the drug is in Phase III for Crohn’s disease and psoriatic arthritis, with another program being prepped for ulcerative colitis.
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