March 18, 2023
1 min read
Armstrong AW, et al. Efficacy and safety results from the randomized double-blind, placebo-controlled phase 2b trial of TYK2 inhibitor NDI-032858 in moderate to severe psoriasis. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.
Armstrong reports having financial relationships with AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Meiji, Modernizing Medicine, Nimbus Therapeutics, Novartis, Ortho Dermatologics, Parexel, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharmaceuticals, UCB and Ventyx Biosciences.
NEW ORLEANS — Phase 2b clinical trial results of Takeda Pharmaceuticals’ novel tyrosine kinase 2 inhibitor found significantly greater skin clearance in study patients compared with placebo, according to a presentation here.
In the phase 2b, randomized, double-blind, placebo-controlled study, April W. Armstrong, MD, MPH, FAAD, professor of dermatology and associate dean for clinical research at Keck School of Medicine of the University of Southern California, and colleagues randomly assigned 259 patients to receive 2 mg, 5 mg, 15 mg or 30 mg of TAK-279 (formerly NDI-034858) once daily or placebo for 12 weeks.
“TAK-279/NDI-034858 has now demonstrated efficacy and safety in a rigorously performed phase 2b trial in moderate to severe plaque psoriasis. This confirms the clinical utility of selectively targeting [tyrosine kinase 2 (TYK2)],” Armstrong told Healio. “The efficacy at the highest doses is impressive and suggests that robust coverage of TYK2 could provide meaningful improvement for patients.”
April W. Armstrong
Results were presented at the American Academy of Dermatology Annual Meeting.
In the treatment groups, the primary endpoint of PASI 75 was achieved by 44% of the 5 mg cohort, 68% of the 15 mg group and 67% of the 30 mg cohort. Only 6% of the placebo group achieved PASI 75.
PASI 90 was reported in 21%, 45% and 46% of the treatment groups, respectively, and PASI 100 was recorded in 10%, 15% and 33% of the treatment groups. This was in comparison to 0% of the placebo group for both outcomes.
“I was pleasantly surprised by the PASI 100 at the highest dose (30 mg daily),” Armstrong told Healio. “Nearly one-third of patients achieved PASI 100 (clear skin) at week 12. This level of skin clearance at week 12 is numerically on par with biologics for psoriasis.”
Adverse events occurred in 53% to 62% of subjects in the treatment groups and 44% of those in the placebo group. One patient experienced serious adverse events considered unrelated to treatment.
“Taken together, these results support further testing in phase 3 and suggest that TAK-279 has the potential to provide an efficacious, safe, oral treatment option for patients with moderate to severe psoriasis,” Armstrong said. “Selective, allosteric inhibition of TYK2 by TAK-279 is a potential treatment approach for several autoimmune diseases. “