Advances to Expand the Range of Options for Treating Psoriasis

The company Takeda has announced the publication of new positive results from two pivotal phase 3 trials of zasocitinib, an oral drug under investigation for moderate-to-severe plaque psoriasis, which the company presents as a potential new once-a-day option. According to the press release issued by the company, the studies met their primary and key secondary objectives, with a tolerability profile consistent with that previously observed.

Oral Therapy

The treatment, developed by Takeda, is a once-daily pill.

PASI (Psoriasis Area and Severity Index) is one of the most commonly used scales in clinical trials to quantify the extent of a person's psoriasis and its severity. Specifically, the available results indicate that zasocitinib was superior to placebo in the two co-primary endpoints at week 16. PASI 75 (75% improvement in the area and severity index) and sPGA 0/1 (medical assessment of clear or almost clear skin). The company adds that the response in PASI 75 was observed from week 4 and continued to increase until week 24.

Beyond these primary endpoints, the statement highlights results in more demanding clearance goals: more than half of the treated participants achieved PASI 90 (clear or almost clear skin) and, on average, about 30% achieved PASI 100 (completely clear skin) by week 16, with rates continuing to increase until week 24. The trials (the LATITUDE program) were global, randomized, double-blind, with comparisons against placebo and an active comparator, apremilast. Takeda states that they were conducted in 21 countries and included 693 and 1,108 participants, respectively.

In terms of safety, the company states that zasocitinib was well tolerated, with no new safety signals, and that the most common adverse events up to week 24 were upper respiratory infection, nasopharyngitis, and acne. Takeda plans to present the results at conferences and start regulatory submissions starting next year.

To understand the scope of this therapeutic innovation, it is noteworthy that until now in moderate-to-severe psoriasis, the standard of high responses and deep clearance has traditionally been associated with biologics, injectables, targeting molecules like IL-17 or IL-23. Dermatology has been striving to achieve similar levels of efficacy with oral treatments, which are more convenient for many patients. In this context, a new oral showing high rates of PASI 90/100 could broaden the range of options for patients who prefer to avoid injectables or seek simpler administration alternatives.

Another key point is the mechanism. Zasocitinib belongs to the generation of selective TYK2 inhibitors, an intracellular enzyme involved in relevant inflammatory pathways. It has the potential to become an option for people living with immune-mediated inflammatory diseases. The company is advancing other studies in psoriatic arthritis, Crohn's disease, ulcerative colitis, and vitiligo, and studies are being initiated in hidradenitis suppurativa.