Takeda has announced positive phase 2b results for its investigational TYK2 inhibitor, TAK-279, in patients with moderate-to-severe plaque psoriasis.
Psoriasis is a chronic autoimmune disease affecting an estimated 125 million people worldwide. Plaque psoriasis accounts for around 80-90% of psoriasis cases and is characterised by raised, red patches of skin that are covered by silvery-white scales which can be itchy and painful.
Results from the study, presented at this year’s American Academy of Dermatology annual meeting, showed 44% of the TAK-279 5mg cohort, 68% of the 15mg group, and 67% of the 30mg cohort achieved the trial’s primary endpoint of a Psoriasis Area and Severity Index (PASI) of 75 at 12 weeks.
A significantly greater proportion of TAK-279-treated patients also achieved PASI 90, at 21% of the 5mg cohort, 45% of the 15mg group, and 46% of the 30mg cohort. Meanwhile, 10% of the 5mg group, 15% of the 15mg group, and 33% of the 30mg group achieved a PASI score of 100.
The Physician Global Assessment (PGA) score of 0/1 was achieved by 27%, 49%, and 52% of the 5mg, 15mg, and 30mg treatment groups, respectively.
April Armstrong, clinical investigator in the phase 2b study and associate dean and professor of dermatology at the University of Southern California, said: “These results further support the potential of highly selective TYK2 inhibition to provide an effective and convenient oral treatment option for people living with moderate-to-severe plaque psoriasis who are not achieving optimal skin clearance with current therapies.”
The company said it plans initiate a phase 3 study of TAK-279 in psoriasis in FY2023. It also expects to receive top line results from a phase 2b trial in psoriatic arthritis and plans to evaluate TAK-279 in other immune-mediated diseases, including systemic lupus erythematosus and inflammatory bowel disease.
Takeda announced that it would be acquiring TAK-279 (then NDI-034858) from Nimbus Therapeutics a few months ago, in December.
Under the terms of the agreement, Takeda said it would make an upfront payment of $4bn to Nimbus, which would also be eligible for two $1bn milestone payments upon achieving annual net sales of $4bn and $5bn.