Corvus Pharmaceuticals, Inc. ( CRVS ) on Thursday released new interim data from the Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.

The data demonstrated a favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 mg) compared to cohorts 1 and 2 (100 mg twice per day and 200 mg once per day, total daily dose 200 mg).

Overall, all three cohorts showed significant responses in the soquelitinib treatment groups compared to placebo for clinically significant endpoints of EASI (Eczema Area and Severity Index) 75 and IGA (Investigator Global Assessment) 0 or 1.

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The percent reduction in mean EASI scores at 28 days for the combined cohort 1 and 2 group was 54.6% for patients receiving soquelitinib and 30.6% for patients receiving placebo.

In cohort 3, the percent reduction in mean EASI score at 28 days was 71.1% for patients receiving soquelitinib and 42.1% for patients receiving placebo.

Separation of the curves for patients receiving active drug began at day 15 and increased by day 28 for cohorts 1 and 2.

Cohort 3 patients experienced earlier and deeper separation from placebo starting by day 8. The combined soquelitinib treatment group is significantly superior to placebo at day 28, p=0.03.

Soquelitinib was well tolerated, with no dose-limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts.

No interruption of drug dosing was seen in any of the cohorts. Grade 1/2 adverse events (treatment-related and unrelated) were seen in 33.3% of patients receiving soquelitinib and 25% receiving placebo.

Only one treatment-related adverse event of grade 1 nausea was reported with soquelitinib treatment.

As reported, relationships between reductions in certain cytokines and improvement in EASI scores were observed.

Differences between responding and non-responding patients were found, while no such relationships were seen in the placebo group.

The number of circulating T regulatory cells increased, consistent with the presumed mechanism of action of soquelitinib.

"We continue to be encouraged by the results from our phase 1 trial of soquelitinib in patients with atopic dermatitis, which show a favorable safety and efficacy profile with a convenient oral tablet. We believe the results are particularly exciting given the relatively short treatment duration of 28 days and durable post-treatment results, both of which we associate with the novel mechanism of action provided by ITK inhibition," said Richard Miller, co-founder, president, and CEO.

"Looking forward, we remain on track with our key potential value-driving initiatives for soquelitinib in atopic dermatitis, including data from our new extension cohort in the fourth quarter and initiating a Phase 2 clinical trial before year-end. We also remain excited about our other soquelitinib clinical programs – patient enrollment in the Phase 3 registration clinical trial in peripheral T cell lymphoma (PTCL) and the Phase 2 trial in autoimmune lymphoproliferative syndrome (ALPS) is ongoing, and we plan to initiate a solid tumor clinical trial later in 2025," Miller added.

As of March 31, 2025, Corvus had cash, cash equivalents and marketable securities of $44.2 million. Based on its current plans, Corvus expects its cash to fund operations into the fourth quarter of 2026.

Price Action: CRVS stock is up 28.40% at $4.30 at the last check on Friday.

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