Takeda has reported positive data from a Phase IIb clinical trial of TAK-279 (NDI-034858) in moderate-to-severe plaque psoriasis patients.
The double-blind, randomised, multiple-dosed, multicentre, placebo-controlled Phase IIb trial has been designed for assessing TAK-279’s tolerability, efficacy, and safety in the indicated patients.
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By GlobalDataIn the trial, 259 participants were randomised in a 1:1:1:1:1 ratio to receive either a 2mg, 5mg, 15mg, or 30mg dose of TAK-279 once-a-day or a placebo for 12 weeks.
According to the findings, 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.
At the 30mg dose of TAK-279, 46% of participants achieved PASI 90 and 33% achieved PASI 100 at 12 weeks.
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.
Takeda research and development president Andy Plump said: “These compelling TAK-279 data strengthen its potential for people with moderate-to-severe plaque psoriasis.
“The highly selective TYK2 inhibition seen with TAK-279 spares inhibition of other members of the Janus kinase (JAK) family, which we believe should avoid JAK-related toxicities.
“We are confident that we can execute a comprehensive development program and deliver a potential best-in-class therapy for patients, given Takeda’s strong background in immune-mediated diseases, including inflammatory bowel disease.”
The company expects to receive topline results from a Phase IIb trial in psoriatic arthritis and intends to commence a Phase III trial of TAK-279 in psoriasis in FY2023.
It also plans to assess TAK-279 in other immune-mediated diseases, including inflammatory bowel disease (IBD) and systemic lupus erythematosus (SLE), as well as other indications in the future.
