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Regeneron Pharmaceuticals, Inc.

Partner : Sanofi-Aventis

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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George D. Yancopoulos, M.D., Ph.D., CSO, gave guidance for data and registrational filing for Dupilumab. He stated, "I share Len’s enthusiasm for Dupilumab, our IL-4/13 pathway blocking antibody, which is currently in phase-III clinical studies in asthma and in adults with moderate to severe atopic dermatitis where it is been granted breakthrough designation, in part because there are no FDA approved systemic therapy for adult patients with moderate to severe atopic dermatitis. We expect to report top line data from the phase-III atopic dermatitis study; SOLO-1, SOLO-2 and CHRONOS in the first half of this year and to complete the rolling BLA submission in the second half of the year. Our approximately 1,700-patient pivotal phase-III study of Dupilumab in asthma is also enrolling. We also continue to explore other indications for Dupilumab such as nasal polyps and eosinophilic esophagitis as well as other allergic or IL-4/13 mediated diseases."
Source: Q4 2015 earnings conference call, 2/09/16.

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October 20, 2014

Regeneron and Sanofi Announce Start of Phase 3 Study of Dupilumab in Patients with Atopic Dermatitis

TARRYTOWN, N.Y. and PARIS, Oct. 20, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications.

LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks. Secondary objectives of the study will evaluate the long-term safety and efficacy of dupilumab up to 52 weeks. The trial will enroll approximately 700 adult patients.

"Moderate-to-severe atopic dermatitis is a serious disease characterized by severe itching, sleep disturbances and widespread rash, and existing treatment options have limited efficacy," said Donald Y. M. Leung, MD, PhD, a member of the LIBERTY AD Clinical Trials Steering Committee and Head of the Division of Pediatric Allergy and Immunology at National Jewish Health in Denver, CO. "This Phase 3 program will evaluate if blocking IL-4 and IL-13, two key cytokines in the Th2 inflammatory pathway, may provide a potential new approach for this chronic, difficult-to-manage disease."

The LIBERTY AD Phase 3 clinical program will consist of at least five trials of patients with moderate-to-severe AD at sites worldwide. For more information on the LIBERTY AD CHRONOS study, please visit: http://clinicaltrials.gov/ct2/show/NCT02260986?term=dupilumab&phase=2&ra....
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Source: press release, 10/20/14. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=876921

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A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Enrollment: 739
Study Start Date: September 2014
Estimated Study Completion Date: November 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02260986?term=dupilumab&phase=2&ra...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Dupilumab (REGN-6885) Atopic DermatitisAllergyAtopic DermatitisInterleukin - 4 and 13 receptor inhibitorInterleukin - 4 and 13 receptors

Mechanism of action: Dupilumab (REGN-6885) is an antibody to the receptors for interleukin-4 and interleukin-13 that is being evaluated in atopic dermatitis and eosinophilic asthma

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-03-01 - 2016-06-30

Results:

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Regeneron and Sanofi Announce that Dupilumab Used with Topical Corticosteroids (TCS) was Superior to Treatment with TCS Alone in Long-term Phase 3 Trial in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients
Moderate-to-severe atopic dermatitis is a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities
These data, along with previous Phase 3 studies, will be part of a U.S. regulatory submission for dupilumab, which is on track for Q3 of 2016
TARRYTOWN, N.Y. and PARIS, June 6, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a one-year Phase 3 study, known as LIBERTY AD CHRONOS, evaluating investigational dupilumab met its primary and key secondary endpoints. In the study, dupilumab with topical corticosteroids (TCS) was compared to TCS alone in moderate-to-severe atopic dermatitis (AD) adult patients. Patients in the study were inadequately controlled by topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI). Dupilumab with TCS significantly improved measures of overall disease severity at 16 and 52 weeks, when compared to placebo with TCS.

"This is the first long-term Phase 3 data that demonstrated dupilumab with topical corticosteroids was superior to topical corticosteroids alone, and provided sustained efficacy, significantly improving measures of overall disease severity, skin clearing, itching, and quality of life through one year of treatment," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Although topical corticosteroids are standard therapies for atopic dermatitis, they are non-specific anti-inflammatory agents, while dupilumab is a targeted therapy that specifically blocks the IL-4/IL-13 signaling pathway. Our collective clinical data demonstrate that this pathway is a root cause in atopic dermatitis, asthma and nasal polyposis and we continue to evaluate the potential of this pathway in these atopic and allergic diseases."

"Dupilumab is an innovative first-in-class investigational agent that has shown significant efficacy and a favorable safety profile in two pivotal Phase 3 studies in monotherapy for moderate-to-severe atopic dermatitis, and now in concomitant administration with topical corticosteroids," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "These one-year data strengthen the earlier 16-week results, suggesting that dupilumab impacts the aberrant activation of the IL-4/IL-13 pathway which resulted in significant efficacy without the side effects associated with immune-suppressing therapies. We will continue to advance dupilumab for patients worldwide suffering from inadequately controlled moderate-to-severe atopic dermatitis, with the first submission planned in the U.S. for the third quarter of this year."

The primary endpoint results at week 16 were the following:

39 percent of patients who received either dupilumab 300 mg weekly with TCS or dupilumab 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12 percent of patients receiving placebo with TCS (p less than 0.0001).
64 percent of patients who received dupilumab 300 mg weekly with TCS, and 69 percent of patients who received dupilumab 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).
The secondary endpoint 52-week results were the following:

40 percent of patients who received dupilumab 300 mg weekly with TCS, and 36 percent of patients who received dupilumab 300 mg every two weeks with TCS achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 12.5 percent of patients receiving placebo with TCS (p less than 0.0001).
64 percent of patients who received 300 mg weekly with TCS, and 65 percent of patients who received 300 mg every two weeks with TCS achieved EASI-75, compared to 22 percent with placebo with TCS (p less than 0.0001).
Patients were less likely to discontinue therapy in the dupilumab with TCS groups compared to placebo with TCS group (15 percent in both dupilumab groups; 33 percent placebo).

The overall rate of adverse events was comparable between the dupilumab with TCS groups (83 percent for the weekly dose (qw) and 88 percent for the every two weeks (q2w) dosing group) and the placebo with TCS group (84 percent). The rate of serious adverse events was comparable between the dupilumab with TCS groups (3 (qw) and 4 percent (q2w)) and placebo with TCS group (5 percent). Serious and/or severe infections were numerically higher in the placebo with TCS group (1 percent in both dupilumab groups and 2 percent placebo). Adverse events that were noted to have a higher rate with dupilumab included injection site reactions (20 (qw) and 16 percent (q2w) dupilumab; 9 percent placebo) and conjunctivitis (19 (qw) and 13 (q2w) percent dupilumab; 8 percent placebo); 22 percent of patients on placebo, and 23 (qw) and 28 percent (q2w) of patients on dupilumab reported a history of allergic conjunctivitis at study entry.

More detailed results, including long-term efficacy and safety data from CHRONOS will be submitted for presentation at a future medical congress.

The U.S. Food and Drug Administration (FDA) granted dupilumab Breakthrough Therapy designation in AD in November 2014. Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. If approved, dupilumab would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business of Sanofi.

The LIBERTY AD Phase 3 clinical program consists of five trials of patients with moderate-to-severe AD at sites worldwide.
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Source: press release, 6/06/16. http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=974316

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