California-based biopharma company Alumis has debuted data from a trio of Phase III studies that the company says highlights the “leading” potential of its tyrosine kinase 2 (TYK2) inhibitor, envudeucitinib, on the oral psoriasis market.
These positive results stem from the ONWARD programme (NCT06586112; NCT06588738; NCT06846541). In the first two trials, ONWARD 1 and ONWARD 2, patients were randomised to receive either envudeucitinib, Amgen’s marketed psoriasis drug, Otezla (apremilast) or placebo, while the open-label ONWARD3 trial looked at the long-term efficacy and safety of envudeucitinib across patients from all arms of ONWARD 1 and 2.
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Building on prior results revealing that 54% of patients treated with twice-daily envudeucitinib had experienced a full response based on the psoriasis area and severity index (PASI) scale at week 48, the TYK2 inhibitor demonstrated a durable disease impact, with 80% of patients in the ONWARD3 study maintaining a scalp considered clear or almost clear of psoriasis at the 48-week mark.
Meanwhile, one in three envudeucitinib-treated patients achieved a clinically meaningful itch reduction within the ONWARD1 and 2 studies, with researchers observing this impact as early as week two. The drug’s impact on itch was also sustained up to 48 weeks in 80% of patients in the open-label study.
On top of the improvements in itch, envudeucitinib also allowed half of treated patients to deem their psoriasis as having minimal to no impact on their daily quality of life (QoL) at week 12, with more than 70% of patients maintaining this after 48 weeks of treatment in ONWARD3.
Patients also tolerated envudeucitinib well, with researchers identifying no new safety signals linked to long-term treatment.
With these positive data in the bag, Alumis will forge on with its efforts to secure envudeucitinib’s approval in plaque psoriasis, with the biopharma company noting that it’s on track to submit a New Drug Application (NDA) for the therapy in the final quarter of 2026.
If approved, the drug would come head-to-head with Bristol Myers Squibb’s (BMS) fellow TYK2 inhibitor, Sotyktu (deucravacitinib), which pulled in $291m in sales last year. However, Alumis hopes to get a leg-up on Sotyktu with its updated mechanism, as the biopharma company has engineered envudeucitinib to engage with and inhibit TYK2 over a 24-hour period.
More concerning for its future may be Johnson & Johnson’s (J&J) newly approved psoriasis pill, Icotyde (icotrokinra), which analysts previously told Pharmaceutical Technology, sister publication to Clinical Trials Arena, achieved “biologic-like efficacy in a once-daily oral pill”, offering a more convenient dosing schedule for patients over envudeucitinib’s twice-daily requirements. They also predict it will become a blockbuster seller in the future.
Jefferies analysts say that this schedule, alongside data that appears to place envudeucitinib’s efficacy under that of both Icotyde and Takeda’s investigational psoriasis drug, zasocitinib, could limit the drug’s potential for differentiation.
