Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS) announced on Tuesday the positive outcomes from cohort 4 of its Phase 1 clinical trial evaluating soquelitinib for patients suffering from moderate-to-severe atopic dermatitis. The data provides further evidence of the drug candidate's potential to deliver significant clinical benefits while maintaining a favorable safety profile.
In response to these results, Corvus Pharmaceuticals’ stock exhibited a sharp rise with trading volume reaching 30.79 million shares, markedly surpassing the average volume of 1.33 million shares. At the last check, shares increased by approximately 140%, trading around $19.28.
The cohort 4 findings reinforced positive trends observed in previous cohorts 1 through 3, particularly highlighting a more pronounced therapeutic response over an extended eight-week treatment period as compared to the initial four weeks. This extended exposure appeared to deepen the clinical effects of soquelitinib.
Crucially, the trial demonstrated ongoing drug activity among patients who had a history of receiving systemic therapies, indicating soquelitinib's potential applicability in a treatment-experienced population. Within cohort 4, patients treated with soquelitinib had a mean baseline Eczema Area and Severity Index (EASI) score of 25.7, compared to 21.9 in the placebo group.
Across the entire pool of 72 participants in all four cohorts, 35% (n=25) had previously undergone systemic treatments, with cohort 4 comprising 50% (n=12) of these cases. Analysis of clinical endpoints revealed that all four cohorts showed meaningful improvements in the soquelitinib groups relative to placebo with regards to EASI 75 (defined as a 75% reduction in EASI) and Investigator Global Assessment (IGA) scores reaching 0 or 1, which denotes clear or almost clear skin.
On day 56 of treatment, patients in cohort 4 receiving soquelitinib (n=12) exhibited an average 72% reduction in EASI scores, compared to a 40% reduction observed in the placebo patients (n=10). The therapeutic response trajectory suggested steady improvement from day 28 through day 56, with an increasing divergence from placebo treatment effects over the same duration.
Importantly, none of the soquelitinib patients experienced disease flares requiring additional therapy during the 56-day period, whereas two placebo patients had flares necessitating treatment intervention.
Biomarker Findings
Biomarker evaluations from cohorts 3 and 4 showed reductions in serum interleukin-4 (IL-4) cytokine levels both during and after treatment, revealing a dose-dependent pattern. Cohort 4 patients demonstrated the most substantial and sustained decreases in IL-4, with effects persisting through day 86. Similarly, cohorts 1 through 3 recorded reductions in serum interleukin-5 (IL-5) levels compared to placebo, including an early onset of IL-5 diminution as soon as day 8 of therapy. Cohort 3 exhibited the largest IL-5 decreases. Additional biomarker analyses reported lower levels of serum interleukin-17 (IL-17) and thymus and activation-regulated chemokine (TARC), indicating a broad immunological modulation by soquelitinib.
Safety Profile
Safety observations as of January 15 indicated no new adverse events or safety concerns among trial participants. Adverse events occurred in 41.7% of patients receiving soquelitinib and 50% of those on placebo. Reported events across both groups were mild to moderate (Grade 1-2) and did not necessitate any changes to dosing or interruptions in therapy. No severe or serious adverse events were documented, and laboratory analyses revealed no significant abnormalities.
Upcoming Phase 2 Trial Plans
Corvus has announced plans to initiate a Phase 2 clinical trial for soquelitinib targeting moderate-to-severe atopic dermatitis in the first quarter of 2026. This next-stage study is expected to enroll roughly 200 patients who have not adequately responded to at least one prior topical or systemic treatment regimen.
The Phase 2 trial design includes four cohorts comprising 50 patients each, testing various dosing schedules: 200 mg once daily, 200 mg twice daily, and 400 mg once daily, alongside a placebo control group. This study stage aims to further evaluate safety and efficacy at a larger scale and optimize dosing strategies.
Summary
Corvus Pharmaceuticals’ recent Phase 1 cohort 4 data reinforce soquelitinib's potential as a treatment for moderate-to-severe atopic dermatitis, with consistent evidence of clinical efficacy and a favorable safety profile over an extended treatment period. The drug shows promise in patients with previous systemic therapy experience and favorable biomarker changes supporting its mechanism of action. The positive trial results have fueled a significant surge in Corvus’ stock price. Plans are underway to commence a larger Phase 2 trial to confirm these findings among a broader patient population.
Key Points
- Phase 1 cohort 4 trial results for soquelitinib indicate favorable efficacy and safety in moderate-to-severe atopic dermatitis patients, consistent with earlier cohorts.
- Soquelitinib demonstrated meaningful improvements in clinical endpoints including EASI 75 and IGA scores compared to placebo after eight weeks of treatment.
- Serum biomarker analysis revealed dose-dependent reductions in IL-4 and IL-5 cytokines, as well as decreases in IL-17 and TARC, supporting immunomodulatory effects.
- No severe or serious adverse events reported; adverse events were mild to moderate and balanced between treatment and placebo groups.
- A Phase 2 trial enrolling approximately 200 patients is scheduled to begin in early 2026, exploring multiple dosage regimens.
Risks and Uncertainties
- The long-term safety and efficacy of soquelitinib remain to be established beyond the Phase 1 trial duration.
- The Phase 1 trial sample size is limited, and responses in broader patient populations could vary.
- Potential regulatory or development challenges could affect the timing and outcomes of the planned Phase 2 trial.
- Previous systemic treatment experience among patients introduces variability in treatment responses that may complicate clinical interpretation.