INVESTORS & MEDIA
News Release
Regeneron and Sanofi Announce Presentation of Positive Data from Long-Term Pivotal Phase 3 CHRONOS Study of DUPIXENT® (dupilumab) in Moderate-to-Severe Atopic Dermatitis
"These new results build upon previous positive Phase 3 monotherapy data. In the CHRONOS study, DUPIXENT used with topical corticosteroids showed significantly greater clearance of skin lesions and overall disease severity compared to topical corticosteroids alone, which are commonly prescribed for moderate-to-severe atopic dermatitis," said
Patients were eligible for participation in the CHRONOS study if their disease was uncontrolled by topical medicines including corticosteroids with or without calcineurin inhibitors. Patients were randomized to receive DUPIXENT 300 mg weekly with TCS, DUPIXENT 300 mg every two weeks with TCS, or placebo with TCS. DUPIXENT with TCS significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with TCS.
As previously announced in
- At 16 weeks, 39 percent of patients who received either DUPIXENT 300 mg weekly with TCS or DUPIXENT 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12 percent of patients receiving placebo with TCS (p less than 0.0001).
- At 16 weeks, 64 percent of patients who received DUPIXENT 300 mg weekly with TCS, and 69 percent of patients who received DUPIXENT 300 mg every two weeks with TCS achieved
EASI -75, a 75 percent reduction on an index measuring eczema severity, compared to 23 percent of patients receiving placebo with TCS (p less than 0.0001). - At 52 weeks, 40 percent of patients who received DUPIXENT 300 mg weekly with TCS, and 36 percent of patients who received DUPIXENT 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12.5 percent of patients receiving placebo with TCS (p less than 0.0001).
- At 52 weeks, 64 percent of patients who received DUPIXENT 300 mg weekly with TCS, and 65 percent of patients who received DUPIXENT 300 mg every two weeks with TCS achieved
EASI -75, compared to 22 percent with placebo with TCS (p less than 0.0001).
New data being presented at the meeting show that:
- At 16 weeks, the mean percent improvement in
EASI from baseline was 77 percent for patients who received DUPIXENT weekly with TCS and for patients who received DUPIXENT every two weeks with TCS, compared to 42 percent for patients receiving placebo with TCS (p less than 0.0001). - At 16 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), was 55 percent for patients who received DUPIXENT weekly with TCS and 58 percent for patients who received DUPIXENT every two weeks with TCS, compared to 29 percent for patients receiving placebo with TCS (p less than 0.0001).
- At 16 weeks, 77 percent of patients who received DUPIXENT weekly with TCS or DUPIXENT every two weeks with TCS achieved a ≥4-point improvement in the severity of their AD, as measured by the Patient Oriented Eczema Measure (POEM), a tool that quantifies the illness as experienced by the patients, compared to 37 percent of patients receiving placebo with TCS (p less than 0.0001).
- At 16 weeks, 74 percent of patients who received DUPIXENT weekly with TCS and 81 percent of patients who received DUPIXENT every two weeks with TCS achieved a ≥4-point improvement in aspects of their quality of life, as measured by the Dermatology Life Quality Index (DLQI), compared to 43 percent of patients receiving placebo with TCS (p less than 0.0001). The DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person.
- At 52 weeks, the mean percent improvement in
EASI from baseline was 80 percent for patients who received DUPIXENT weekly with TCS and 78 percent for patients who received DUPIXENT every two weeks with TCS, compared to 46 percent for patients receiving placebo with TCS (p less than 0.0001). - At 52 weeks, the mean percent improvement from baseline in the intensity of patient-reported itch, as measured by the NRS, was 54 percent for patients who received DUPIXENT weekly with TCS and 56 percent for patients who received DUPIXENT every two weeks with TCS, compared to 27 percent for patients receiving placebo with TCS (p less than 0.0001).
- At 52 weeks, 65 percent of patients who received DUPIXENT weekly with TCS and 76 percent of patients who received DUPIXENT every two weeks with TCS achieved a ≥4-point improvement in the severity of their AD, as measured by POEM, compared to 26 percent of patients receiving placebo with TCS (p less than 0.0001).
- At 52 weeks, 63 percent of patients who received DUPIXENT weekly with TCS and 80 percent of patients who received DUPIXENT every two weeks with TCS achieved a ≥4-point improvement their quality of life, as measured by the DLQI, compared to 30 percent of patients receiving placebo with TCS (p less than 0.0001).
In the CHRONOS trial, 85 percent of patients who received DUPIXENT weekly with TCS and 86 percent of patients who received DUPIXENT every two weeks with TCS completed the 52-week treatment, compared to 67 percent of patients in the placebo group. Patients who received DUPIXENT with TCS had higher rates of injection site reactions (19 percent DUPIXENT weekly, 15 percent DUPIXENT every two weeks and 8 percent TCS alone) and cases of conjunctivitis (19 percent DUPIXENT weekly, 14 percent DUPIXENT every two weeks and 8 percent TCS alone).
The DUPIXENT Biologics License Application (BLA) was accepted for Priority Review by the
DUPIXENT is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. If approved, DUPIXENT would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of
About Atopic Dermatitis
AD is the most common form of eczema and is characterized by unpredictable flare-ups. It is a chronic inflammatory disease with symptoms often appearing on the skin. Moderate-to-severe AD is characterized by rashes and can include intense, persistent and debilitating itching, skin dryness, cracking, redness, crusting, and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.
It's estimated approximately 300,000 people in
About
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
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