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Here it is!
$Corvus Pharmaceuticals (CRVS.US)$ Corvus Pharmaceuticals Announces Interim Data from Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
Data from lowest dose level cohorts demonstrate a favorable safety and efficacy profile
Data includes complete results from cohort 1 and initial results from cohort 2
Early exercise of common stock warrants from stockholder generates cash proceeds of approximately $12.7 million
Company to host conference call and webcast today at 8:00 a.m. ET / 5:00 a.m. PT
BURLINGAME, Calif., December 18, 2024 - Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced 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 profile and efficacy profile, supporting the ongoing development of soquelitinib for atopic dermatitis and the potential of ITK inhibition as a novel mechanism of action for other immune diseases.
“We are pleased with the early results of our soquelitinib Phase 1 atopic dermatitis clinical trial, which show an attractive potential product profile at the lowest dose we are studying,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The data show consistent signs of efficacy, combined with a novel mechanism of action, a convenient oral route of administration and a favorable safety profile. This is also supported by an analysis of serum cytokine levels, which show a possible relationship between clinical response and reductions in IL-5, IL-17, IL-31, IL-33 and TSLP, along with a trend for TARC. We believe the data highlights soquelitinib’s potential as a new treatment option for atopic dermatitis and the broader opportunity for ITK inhibition for other immune related diseases. In addition to blocking the production of multiple inflammatory cytokines, soquelitinib may have persistent direct effects on immune cell function that act to regulate aberrant immune responses. We look forward to completing the Phase 1 trial and initiating other trials with soquelitinib for immune diseases.”
Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Design
The randomized, double-blind, placebo-controlled Phase 1 clinical trial is planned to enroll 64 patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy. Patients are enrolled into one of four dosing cohorts in a 3:1 ratio (12 active and 4 placebo) to receive either soquelitinib or placebo. The cohorts are sequentially enrolled and will examine 100 mg oral twice per day, 200 mg oral once per day, 200 mg oral twice per day and 400 mg oral once per day. Patients are treated for 28 days and are then followed for an additional 30 days with no therapy.
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 bracket the 200 mg oral twice a day dosing regimen, 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, and efficacy, measured by improvement in Eczema Area and Severity Index (EASI) score, Investigator Global Assessment (IGA), reduction in itch and various cytokine biomarkers. 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 will be able to monitor the data from the trial as the trial progresses.
Data from lowest dose level cohorts demonstrate a favorable safety and efficacy profile
Data includes complete results from cohort 1 and initial results from cohort 2
Early exercise of common stock warrants from stockholder generates cash proceeds of approximately $12.7 million
Company to host conference call and webcast today at 8:00 a.m. ET / 5:00 a.m. PT
BURLINGAME, Calif., December 18, 2024 - Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced 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 profile and efficacy profile, supporting the ongoing development of soquelitinib for atopic dermatitis and the potential of ITK inhibition as a novel mechanism of action for other immune diseases.
“We are pleased with the early results of our soquelitinib Phase 1 atopic dermatitis clinical trial, which show an attractive potential product profile at the lowest dose we are studying,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The data show consistent signs of efficacy, combined with a novel mechanism of action, a convenient oral route of administration and a favorable safety profile. This is also supported by an analysis of serum cytokine levels, which show a possible relationship between clinical response and reductions in IL-5, IL-17, IL-31, IL-33 and TSLP, along with a trend for TARC. We believe the data highlights soquelitinib’s potential as a new treatment option for atopic dermatitis and the broader opportunity for ITK inhibition for other immune related diseases. In addition to blocking the production of multiple inflammatory cytokines, soquelitinib may have persistent direct effects on immune cell function that act to regulate aberrant immune responses. We look forward to completing the Phase 1 trial and initiating other trials with soquelitinib for immune diseases.”
Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Design
The randomized, double-blind, placebo-controlled Phase 1 clinical trial is planned to enroll 64 patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy. Patients are enrolled into one of four dosing cohorts in a 3:1 ratio (12 active and 4 placebo) to receive either soquelitinib or placebo. The cohorts are sequentially enrolled and will examine 100 mg oral twice per day, 200 mg oral once per day, 200 mg oral twice per day and 400 mg oral once per day. Patients are treated for 28 days and are then followed for an additional 30 days with no therapy.
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 bracket the 200 mg oral twice a day dosing regimen, 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, and efficacy, measured by improvement in Eczema Area and Severity Index (EASI) score, Investigator Global Assessment (IGA), reduction in itch and various cytokine biomarkers. 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 will be able to monitor the data from the trial as the trial progresses.
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seer84 : Seat back and let it flyyyyy
Trytosaveabit OP seer84 : Indeed! That’s what I’m hoping over the next few days! Just hope yesterdays rise is not a signal it’s going to dump on good data news like several others have over the last 2 weeks? GL to ya![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")
novice g : Sigh..looks like it’s another sell on news again
Trytosaveabit OP novice g : It’s possible? But there is like no volume yet! Gotta see what open market brings! GL
71179109 : dump again
102535039 novice g : Looks like it broke support, is below MA 100, 35, 7. Looking bad.