Soquelitinib Demonstrates Efficacy in Atopic Dermatitis After Systemic Failure

At the 2026 Society for Investigative Dermatology Annual Meeting in Chicago, Illinois, new phase 1 data on soquelitinib for moderate to severe atopic dermatitis (AD) were presented by Albert Chiou, MD, MBA, a dermatologist, clinical professor of dermatology, and director for clinical research within the department of dermatology at Stanford School of Medicine.

In the first part of his interview, Chiou discussed soquelitinib’s potential remittive effects and subsequent durability data.

Soquelitinib Efficacy in Prior Systemic Therapy Failures

As Chiou noted in his most recent interview, the phase 1 trial was intentionally designed to enroll a high proportion of patients with prior systemic exposure, with more than one-third of participants falling into this category.¹

For patients with AD who do not respond to or cannot tolerate currently approved first-line systemic agents, including IL-13 inhibitors and Janus kinase (JAK) inhibitors, few mechanistically distinct oral options exist. Soquelitinib represents a different mechanism of action and, based on early-phase data, may be relevant for this harder-to-treat population.

Response curves for patients with prior systemic exposure closely mirrored those of the overall trial cohort, a signal Chiou described as meaningful given the intentional enrollment design.¹ A focused subgroup analysis examined patients treated at the highest tested doses who had documented prior systemic failures. Six patients met this criterion; all had not achieved efficacy with dupilumab, and several had failed additional agents. Four were randomized to active soquelitinib treatment, and 3 of those 4 responded, with 2 showing marked improvement.¹ The 2 patients with documented prior systemic failures randomized to placebo both flared during the trial, defined as requiring rescue medication.¹ While the subgroup is small, the consistency of the directional signal across this population supports continued investigation in later-phase trials.

Safety Profile

Across all tested cohorts, the adverse event profile for soquelitinib was well balanced relative to placebo.¹ Review of individual adverse event tables showed no clustering of events in the active treatment arm. Chiou noted investigators specifically assessed for infectious signals and hematologic or laboratory abnormalities, and none were identified during the trial.¹

"This was one of the most encouraging parts of the trial — for all the tested cohorts there is a very clean safety profile. If you look at the frequency of adverse events between the soquelitinib-treated patients and the placebo-treated patients, you can see it was very well balanced," Chiou said.

He placed the safety findings in the context of current AD treatment trade-offs: "We have highly efficacious oral medicines, but with substantive safety considerations. And then we have very good biologics with great safety profiles, but oftentimes some more intermediate trade-offs on efficacy."

For clinicians managing patients who have exhausted first-line biologics or require an oral option with a favorable tolerability profile, soquelitinib's phase 1 signal warrants attention. Additional trials are underway, and formal publication of the complete dataset will be needed to evaluate primary end point data, full response rates, and longer-term safety across the broader trial population.

Reference

1. Chiou A, Cameron M, Parish J, et al. Soquelitinib, an ITK inhibitor, produces prolonged drug-free remission in atopic dermatitis. Poster presented at: 2026 Society for Investigative Dermatology Annual Meeting; May 13-26, 2026; Chicago, IL

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