AbbVie has posted a trio of positive phase III trials for its interleukin-23 inhibitor risankizumab, setting up regulatory applications but also a tough entry into an increasingly crowded psoriasis market.
The anti-interleukin-23 (IL-23) antibody met all its objectives in the three late-stage trials, including showing superiority in clearing skin lesions compared to two blockbuster psoriasis therapies – Stelara (ustekinumab) from Janssen, an IL-12/IL-23 inhibitor, and AbbVie’s own anti-TNF drug Humira (adalimumab).
Depending on the dose, 84% to 88% of risankizumab-treated patients had clear or almost clear skin after 16 weeks, and the results also suggested longer-term efficacy with 56% and 60% of patients on the drug in the trials completely free of lesions after a year. On that form the product should be ready for filing next year and approval in 2019, according to the company.
The solid results bode well for approval of the drug, which AbbVie licensed from Boehringer Ingelheim for $595m upfront last year, but commercial success could be a tougher proposition.
The last couple of years have seen a number of new psoriasis drugs reach the market that have outperformed Stelara and TNF blockers in trials, including Novartis IL-17 inhibitor Cosentyx (secukinumab) which is making rapid headway in the market and is starting to generate compelling long-term efficacy and safety data.
Since its debut in 2015 Cosentyx has been joined by IL-17 inhibitors from Eli Lilly and Valeant, while Johnson & Johnson has IL-23 blocker Tremfya (guselkumab) approved in the US and recommended for approval by the EU’s Committee for Medicinal Products for Human Use (CHMP).
AbbVie’s also developing risankizumab for other immunological indications – in common with its competitors – and reported phase II data in Crohn’s disease at this year’s Digestive Diseases Week meeting with a phase III programme due to start before the end of the year, along with late-stage trials in ulcerative colitis. Phase II data in psoriatic arthritis is due shortly, with phase III studies expected to begin in the first half of 2018.
Meanwhile, risankizumab isn’t the only drug in AbbVie’s pipeline that it hopes will build momentum before it loses patent protection for Humira – currently the biggest-selling drug in the world – sometime around 2022.
The company also has JAK inhibitor upadacitinib in development, which has phase III data in hand in rheumatoid arthritis, another key indication for Humira.