8-K: Corvus Pharmaceuticals Reports Strong Interim Phase 1 Data for Soquelitinib in Atopic Dermatitis, Advances to Extension Cohort

Corvus Pharmaceuticals announced positive interim results from its Phase 1 clinical trial of soquelitinib for moderate to severe atopic dermatitis, demonstrating favorable safety and efficacy, and has initiated an extension cohort.

Summary

• Corvus Pharmaceuticals released new interim data from its randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis.
• The data includes 28-day follow-up results for all patients in cohort 3, showing 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, data from cohorts 1-3 demonstrated a favorable safety and efficacy profile, including a statistically significant improvement in Eczema Area and Severity Index (EASI) score for soquelitinib treated patients compared to placebo at day 28 (p=0.036).
• As of May 28, 2025, enrollment in cohorts 1, 2, and 3 was completed for a total of 48 patients (36 receiving soquelitinib and 12 placebos), all of whom completed the 28-day treatment course.
• Patients in cohort 3 had more advanced disease at baseline; at 28 days, the mean reduction in EASI for cohort 3 (n=12) was 64.8%, compared to 54.6% for cohort 1 and 2 combined (n=24) and 34.4% for placebo (n=12).
• Separation of active drug curves from placebo began at day 15 for cohorts 1 and 2, and earlier by day 8 for cohort 3, with EASI scores continuing to improve out to day 58.
• No placebo patients achieved IGA (Investigator Global Assessment) 0 or 1 or EASI 75 at day 28, while treated patients did, with one additional cohort 3 patient achieving EASI 75 (89% reduction) and IGA 1.
• Patient-reported itch reduction (Peak Pruritus Numerical Rating Scale, PP-NRS) showed 4 of 8 evaluable cohort 3 patients (50%) had a clinically meaningful 4-point reduction from baseline at day 28, compared to 1 of 10 evaluable placebo patients (10%).
• Safety data as of May 28, 2025, showed no new safety signals; soquelitinib was well tolerated with no dose limiting toxicities or clinically significant laboratory abnormalities, and no interruption of drug dosing.
• Grade 1/2 adverse events were observed in 38.9% of soquelitinib patients and 25% of placebo patients, with only one treatment-related adverse event (Grade 1 nausea) reported for soquelitinib.
• Reductions in serum cytokine levels (IL-5, IL-9, IL-17, IL-31, IL-33, TSLP, TARC) were observed, with greater reductions in cohort 3, and increasing trends in circulating T regulatory cells consistent with the presumed mechanism of action.
• Corvus announced the enrollment of the first patient(s) in a new extension cohort of the Phase 1 trial, planned for 24 patients randomized 1:1 (active/placebo) at the cohort 3 dose (200 mg orally twice per day) for an 8-week treatment period.

Sentiment

Score: 8

Explanation: The interim Phase 1 data for soquelitinib in atopic dermatitis is highly encouraging, demonstrating statistically significant efficacy, a favorable safety profile, and clinically meaningful improvements in key symptoms like itch. The decision to initiate an extension cohort with a longer treatment duration further underscores the company's confidence in the drug's potential, indicating strong positive progress.

Positives

• Soquelitinib demonstrated a statistically significant improvement in EASI score (p=0.036) compared to placebo at day 28.
• The higher dose cohort (Cohort 3) showed earlier (by day 8) and deeper (64.8% mean EASI reduction) responses, indicating a dose-dependent benefit.
• The drug exhibited a favorable safety and efficacy profile, being well tolerated with no dose limiting toxicities or clinically significant laboratory abnormalities.
• Clinically meaningful reductions in itch were observed, with 50% of evaluable cohort 3 patients achieving a 4-point reduction in PP-NRS score.
• Treated patients achieved FDA-recognized clinically meaningful endpoints (IGA 0 or 1, EASI 75), which were not observed in the placebo group.
• Biomarker studies showed reductions in key cytokines and increasing trends in T regulatory cells, supporting the drug's presumed mechanism of action.
• The initiation of an extension cohort with a longer treatment duration (8 weeks) signals confidence in the drug's potential for further improvement in patient results.

Negatives

• Grade 1/2 adverse events were reported in a higher percentage of soquelitinib-treated patients (38.9%) compared to placebo (25%), although only one was treatment-related (nausea).
• Some patients had incomplete PP-NRS data or low baseline PP-NRS, which limited the full evaluation of itch reduction across all patients.

Risks

• The Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates.
• The accuracy of the Company's estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials.
• The results of preclinical studies and interim data from clinical trials not being predictive of future results.
• The Company's ability to enroll sufficient numbers of patients in its clinical trials.
• The unpredictability of the regulatory process.
• Regulatory developments in the United States and foreign countries.
• The costs of clinical trials may exceed expectations.
• The Company's ability to raise additional capital.

Future Outlook

Corvus Pharmaceuticals plans to explore the potential for further improvement in patient results with a longer treatment duration in the recently initiated extension cohort of the Phase 1 trial. The company believes that ITK inhibition with soquelitinib has the potential to be a safe, effective, and convenient new option for patients with atopic dermatitis and other immune diseases, and it intends to continue advancing its clinical pipeline.

Management Comments

• "The complete 28-day data from cohort 3 of our Phase 1 trial of soquelitinib in patients with atopic dermatitis is in-line with the data update we provided at the Society for Investigative Dermatology meeting last month." Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus.
• "We are encouraged that results from cohort 3 continue to show earlier and deeper responses, along with a reduction in itch, which is an important factor for patients." Richard A.2 Miller, M.D.
• "We look forward to exploring the potential for further improvement in patient results with longer treatment duration that is being studied in our recently initiated extension cohort." Richard A. Miller, M.D.
• "Overall, the data to date is supportive of our view that ITK inhibition with soquelitinib has the potential to be a safe, effective and convenient new option for patients with atopic dermatitis and other immune diseases." Richard A. Miller, M.D.

Industry Context

Atopic dermatitis is a chronic inflammatory skin condition affecting millions globally. The development of novel oral small molecule therapies like soquelitinib, an ITK inhibitor, represents a significant advancement in the treatment landscape. This approach could offer a convenient and potentially safer alternative to existing treatments, including biologics or other oral medications, by targeting a specific pathway in immune cell activation. The positive interim data positions soquelitinib as a promising candidate in a competitive but high-need therapeutic area.

Comparison to Industry Standards

• The trial utilized EASI (Eczema Area and Severity Index) and IGA (Investigator Global Assessment) 0 or 1, and EASI 75 as endpoints, which are recognized by the U.S. Food and Drug Administration (FDA) as clinically meaningful and approvable endpoints, consistent with those used in clinical trials for other FDA-approved atopic dermatitis treatments.
• A reduction of 4 points from baseline on the Peak Pruritus Numerical Rating Scale (PP-NRS) is considered a clinically meaningful result for itch reduction, providing a benchmark against which soquelitinib's performance can be assessed.

Stakeholder Impact

• Shareholders: The positive clinical trial results are likely to increase investor confidence and could positively impact the company's stock price due to de-risking of the drug candidate.
• Patients: Soquelitinib shows promise as a safe, effective, and convenient oral treatment option for moderate to severe atopic dermatitis, potentially offering significant improvement in symptoms like skin lesions and itch, thereby enhancing quality of life.
• Employees: Continued positive clinical development supports the company's growth trajectory and job security for its workforce.

Next Steps

• Continue enrollment of 24 patients in the extension cohort of the Phase 1 trial, with an 8-week treatment period.
• Dr. Richard A. Miller, CEO, will present the new interim data at the Jefferies Global Healthcare Conference on June 5, 2025.
• Further evaluation of EASI scores for treated patients from all cohorts out to day 58.

Key Dates

Recommendation

Keywords

Corvus Pharmaceuticals, soquelitinib, atopic dermatitis, eczema, Phase 1 clinical trial, ITK inhibition, biopharmaceutical, dermatology, clinical data, drug development, CRVS, EASI, IGA, PP-NRS