Corvus Pharmaceuticals Announces Data from Cohorts 1-3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis

Rhea-AI Summary

Corvus Pharmaceuticals (NASDAQ: CRVS) reported positive interim data from its Phase 1 clinical trial of soquelitinib for moderate to severe atopic dermatitis. The trial showed favorable safety and efficacy profiles, with Cohort 3 (200mg twice daily) demonstrating earlier and deeper responses compared to Cohorts 1-2. Key findings include: - Cohort 3 achieved 71.1% reduction in mean EASI score vs 42.1% for placebo - Combined Cohorts 1-2 showed 54.6% reduction vs 30.6% for placebo - Treatment was well-tolerated with no dose-limiting toxicities - Positive biomarker results showing reduction in inflammatory cytokines Based on these results, Corvus has amended the trial protocol to evaluate an additional 24 patients at 200mg twice daily for an extended 8-week treatment period. The company plans to initiate a Phase 2 trial by year-end.

Positive

• Strong efficacy with 71.1% EASI score reduction in Cohort 3 vs 42.1% for placebo
• Favorable safety profile with no dose-limiting toxicities
• Earlier and deeper treatment responses observed in higher dose cohort
• Evidence of multiple therapeutic effects through ITK inhibition
• Protocol amendment to expand trial with extended treatment duration

Negative

• Cohort 3 patients had more severe disease at baseline
• Higher proportion of patients in Cohort 3 failed prior systemic therapies
• Limited treatment duration of 28 days in initial cohorts

Insights

Pharmaceutical Clinical Development Expert

Corvus reports promising Phase 1 results for soquelitinib in atopic dermatitis, showing dose-dependent efficacy and strong safety profile.

The Phase 1 data for soquelitinib presents remarkably strong efficacy signals for an early-stage trial. At the highest dose (cohort 3: 200mg BID), patients achieved 71.1% reduction in EASI scores versus 42.1% for placebo, with separation beginning as early as day 8. The combined treatment group showed statistical significance (p=0.03) compared to placebo at day 28.

What's particularly noteworthy is the achievement of EASI-75 in 56.2% of cohort 3 patients and IGA 0/1 in 43.8% - both FDA-recognized approvable endpoints. This level of response after just 28 days of treatment is impressive, especially considering cohort 3 enrolled patients with more severe disease and higher rates of prior treatment failure.

The safety profile is exceptionally clean, with only one treatment-related adverse event (grade 1 nausea) reported across all treated patients. No dose-limiting toxicities or lab abnormalities were observed, allowing continuous dosing.

The protocol amendment to replace cohort 4 with an extended 8-week treatment arm at the 200mg BID dose is strategically sound. The ITK inhibition mechanism appears to offer multiple beneficial effects, including inflammatory cytokine reduction and potential T-regulatory cell induction, potentially explaining the durable post-treatment response. This oral tablet formulation could offer significant advantages over injectable biologics currently dominating advanced atopic dermatitis treatment.

Dermatology Research Specialist

The biomarker data provides compelling mechanistic validation for soquelitinib's clinical effects. The observed reductions in IL-5, IL-9, IL-17, IL-31, IL-33, TSLP, and TARC represent a broad impact across multiple inflammatory pathways crucial in atopic dermatitis pathophysiology. This differs from most approved biologics that typically target single cytokines.

The correlation between cytokine reductions and EASI improvements only in responding patients (not placebo) strengthens the evidence that these are drug-specific effects. Particularly intriguing is the potential induction of T-regulatory cells, which could help explain the durable response observed after treatment discontinuation - suggesting possible disease-modifying effects beyond symptom suppression.

The efficacy demonstrated across clinically meaningful endpoints (EASI-75 and IGA 0/1) is notable given these are the same endpoints used for FDA approval of established treatments. The dose-dependent response provides clear direction for future development, with the highest dose (200mg BID) showing superior kinetics and magnitude of effect.

For context, these results compare favorably to early-phase data from other successful atopic dermatitis drugs. The oral route of administration addresses a significant unmet need, as many patients find topicals burdensome and prefer to avoid injections. If these results are maintained in larger trials with extended treatment duration, soquelitinib could potentially offer a best-in-class profile combining efficacy, safety, convenience, and unique mechanistic benefits including potentially durable remission.

Data continue to demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2

Data to be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting

Company to discuss data today on its first quarter 2025 business update conference call and webcast at 4:30 pm ET / 1:30 pm PT

SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled 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.

“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,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “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. This is supported by biomarker studies from the trial, which show evidence of multiple effects derived from the selective blockade of ITK including the reduction of various inflammatory cytokines and the potential induction of T regulatory cells, further amplifying the disease modifying effects of soquelitinib. Based on these results, we have amended the trial protocol to evaluate an additional 24 patients at the 200 mg twice per day dose, randomized one-to-one with placebo for an extended treatment period of 8 weeks. This amendment gives us the opportunity to evaluate the potential for even stronger efficacy with longer treatment duration. This additional experience is intended to help optimize the design of a Phase 2 trial, which we are on track to initiate before the end of the year.”

Soquelitinib Interim Data from the Atopic Dermatitis Phase 1 Clinical Trial
As of May 6, 2025, enrollment into cohorts 1, 2 and 3 has been completed for a total of 48 patients. The data covers 32 patients receiving soquelitinib and 12 placebos with 28-day follow-up, and four additional patients receiving soquelitinib with 15-day follow-up from cohort 3. These four patients have not yet completed the 28-day treatment course.

Baseline patient characteristics are shown below in Table 1. Patients enrolled in cohort 3 had more severe disease with higher mean baseline EASI scores compared to cohorts 1 and 2. A higher proportion also failed prior systemic therapies. Across all cohorts, the mean EASI scores are 22.3 and 21.2 for active and placebo, respectively. Placebo (n=12) and active (n=36) treatment groups were well-balanced with regard to baseline characteristics.

Table 1: Patient Characteristics

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.

Figure 1 below shows the percent of patients that achieved IGA 0 or 1 or EASI 75 at day 28 of treatment. The placebo patients from cohort 1 (n=4), cohort 2 (n=4) and cohort 3 (n=4) are combined, with no placebo patients achieving IGA 0 or 1 or EASI 75. IGA 0 or 1 and EASI 75 have been determined by the U.S. Food and Drug Administration (FDA) to be clinically meaningful and approvable endpoints and have been the endpoints used in clinical trials for other FDA approved treatments for atopic dermatitis.

Figure 1: Percent Patients Achieving Endpoints IGA 0 or 1, EASI 75 at Day 28 of Treatment

The graphs below (Figures 2 and 3) show the kinetics of response for each of the cohorts and for the combined cohorts 1, 2 and 3. The placebo patients (n=12) are combined in both graphs. 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.

Figure 2: Percent Reduction in Mean EASI Score for Cohorts 1, 2 and 3. Mean percent change in EASI score over time is shown. Treatment beginning is designated “Baseline” and days post-baseline are shown. Screening to baseline data is shown and demonstrates relative disease stability. The study blinding remains in effect for the entire 58-day period. Numbers at the top of the graphs indicate numbers of patients evaluated at the various time points.

Figure 3: Percent Reduction in Mean EASI Score for Combined Cohorts 1, 2 and 3. The data is displayed below with cohorts combined. Four active patients in cohort 3 have not yet reached day 28 of treatment.

Safety Data
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.

Serum Cytokine and Other Biomarker Studies
As reported previously, relationships between reductions in certain cytokines with improvement in EASI scores were observed. Reductions in serum cytokine levels were seen for IL-5, IL-9, IL-17, IL-31, IL-33, TSLP and TARC. Differences between responding and non-responding patients were found, while no such relationships were seen in the placebo group. Increasing trends were seen in numbers of circulating T regulatory cells, consistent with the presumed mechanism of action of soquelitinib.

Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Design and Protocol Update
The randomized, double-blind, placebo-controlled Phase 1 clinical trial was designed to enroll 64 patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy. Patients were planned to be enrolled into one of four dosing cohorts in a 3:1 ratio (12 active and four placebo) to receive either soquelitinib or placebo. The cohorts are sequentially enrolled and will examine 100 mg orally twice per day, 200 mg orally once per day, 200 mg orally twice per day and 400 mg orally once per day. Patients are treated for 28 days and are then followed for an additional 30 days with no therapy. The Company amended the clinical trial protocol to replace cohort 4 (400 mg once per day) with 24 patients randomized 1:1 between active and placebo. Treatment for this group will be extended to 8 weeks with additional 30-day follow-up with no treatment. The dose level for this group is planned to be the same as cohort 3 – 200 mg orally twice per day.

These doses were selected based on the Company’s prior experience evaluating soquelitinib in T cell lymphoma patients. The doses in the atopic dermatitis trial studied in cohorts 1 and 2 are lower than the 200 mg orally twice a day dosing regimen (same dose as cohort 3 of the atopic dermatitis trial), which is the level that has been shown to provide complete ITK occupancy and that is being evaluated in the Company’s ongoing registrational Phase 3 clinical trial of soquelitinib in peripheral T cell lymphoma.

The primary endpoints include safety and tolerability. Efficacy, measured by improvement in EASI score and IGA, are secondary endpoints. Reduction in itch and various cytokine biomarkers are exploratory endpoints. EASI scores are also evaluated by the percent of patients that achieve a specified percent reduction in EASI score – EASI 50 for patients that achieved a 50% reduction; EASI 75 for a 75% reduction; and EASI 90 for a 90% reduction. Corvus and a data monitoring committee monitor the data from the trial as the trial progresses.

Presentation at Society for Investigative Dermatology 2025 Annual Meeting
The data from the Phase 1 clinical trial of soquelitinib for atopic dermatitis will be presented by Albert S. Chiou, M.D., MBA, Clinical Associate Professor, Dermatology and Director of Clinical Research in the Department of Dermatology at Stanford University Medical Center. Dr. Chiou’s clinical focus is in medical dermatology and he conducts clinical trials investigating new therapies for inflammatory and genetic skin disease, including atopic dermatitis. The details of Dr. Chiou’s presentations are as follows:

• Abstract Title: Soquelitinib, a selective ITK inhibitor demonstrates activity in atopic dermatitis phase 1 clinical trial by a novel mechanism of action
• Abstract #: 0437
• Poster Presentation Date and Time: May 8, 2025 from 4:30 – 6:00 pm PT
• Oral Presentation Date and Time: May 10, 2025 from 9:50 – 10:00 am PT 

Upcoming Presentation and Webcast
Dr. Miller will present details on the new data from the soquelitinib Phase 1 clinical trial during the Company’s first quarter 2025 business update conference call and webcast today, Thursday, May 8, 2025 at 4:30 pm ET / 1:30 pm PT. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast, which will include presentation slides, may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 60 days.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements related to the potential of the Company’s product candidates including soquelitinib and the interim results from the Phase 1 trial of soquelitinib in patients with atopic dermatitis, the design and timing of initiation of a Phase 2 trial, the advancement of ITK inhibition and the opportunities it provides, and continued advancement of the Company’s clinical pipeline. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Quarterly Report on Form 10-Q for the first quarter ended March 31, 2025, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: 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; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/08905c00-1401-44f7-a727-57f812163f24

https://www.globenewswire.com/NewsRoom/AttachmentNg/f00ab519-b9f4-45cd-9a86-2164be1c8931

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FAQ

What were the key results from CRVS's Phase 1 trial of soquelitinib for atopic dermatitis?

The trial showed favorable safety and efficacy, with Cohort 3 (200mg twice daily) achieving 71.1% reduction in mean EASI score vs 42.1% for placebo. Combined Cohorts 1-2 showed 54.6% reduction vs 30.6% for placebo, with no dose-limiting toxicities reported.

How safe is Corvus Pharmaceuticals' soquelitinib in treating atopic dermatitis?

Soquelitinib demonstrated a favorable safety profile with no dose-limiting toxicities or clinically significant laboratory abnormalities. Only 33.3% of patients experienced Grade 1/2 adverse events, with just one treatment-related Grade 1 nausea case reported.

What is the dosing regimen for CRVS's soquelitinib in the Phase 1 trial?

The trial tested three dosing cohorts: Cohort 1 (100mg twice daily), Cohort 2 (200mg once daily), and Cohort 3 (200mg twice daily). The most effective dose was 200mg twice daily in Cohort 3.

What are the next steps for Corvus Pharmaceuticals' soquelitinib development?

Corvus has amended the trial to evaluate 24 additional patients at 200mg twice daily for 8 weeks and plans to initiate a Phase 2 trial before the end of 2025.

How does soquelitinib work in treating atopic dermatitis?

Soquelitinib works through ITK inhibition, reducing inflammatory cytokines (IL-5, IL-9, IL-17, IL-31, IL-33, TSLP, TARC) and potentially inducing T regulatory cells, providing disease-modifying effects.