Biotechnology Events

Home

Regeneron Pharmaceuticals, Inc.

.

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

.

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.
.

SOLO-2 - A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Enrollment: 708
Study Start Date: November 2014
Estimated Study Completion Date: January 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
More
Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02277769

.

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:

.

Sanofi and Regeneron Announce Positive Dupilumab Topline Results from Two Phase 3 Trials in Inadequately Controlled Moderate-to-Severe Atopic Dermatitis Patients

Dupilumab is first systemic therapy to show positive Phase 3 results in patients with moderate-to-severe atopic dermatitis, a serious, chronic inflammatory skin disease marked by widespread rash, itching and associated psychosocial comorbidities

Friday, April 1, 2016 8:26 am EDT
Dateline:
Paris, France and Tarrytown, NY
EmailPDFPrint
"In the U.S., where dupilumab in atopic dermatitis has been granted Breakthrough Therapy designation by the U.S. FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible."
Sanofi and Regeneron Pharmaceuticals, Inc. announced that two placebo-controlled Phase 3 studies evaluating investigational dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD) met their primary endpoints. In the studies, known as LIBERTY AD SOLO 1 and SOLO 2, treatment with dupilumab as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, quality of life, and mental health.

"These are the first Phase 3 studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over one million Americans,"said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "These data provide strong evidence that the IL-4 and IL-13 signaling pathway is a fundamental driver of inflammation in atopic dermatitis. Dupilumab is the first in a new class of immunotherapies - in these 16 week trials, dupilumab blocked the aberrant activation of this pathway, resulting in significant efficacy without evidence of immune-suppressing side effects. We continue to evaluate the role of IL-4 and IL-13 signaling in related inflammatory conditions, including asthma and nasal polyposis, where we have ongoing dupilumab clinical development."

"There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need. These results may bring new hope to AD patients, many of whom have suffered for years," said Elias Zerhouni, M.D., President, Global R&D, Sanofi. "In the U.S., where dupilumab in atopic dermatitis has been granted Breakthrough Therapy designation by the U.S. FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible."

A total of 1,379 adult patients with moderate-to-severe AD were enrolled in the identically-designed SOLO 1 and SOLO 2 trials. Patients were enrolled if they were not adequately controlled with topical medications, or if topical treatment was not medically advisable. All patients were assessed via the 5-point Investigator's Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe); entry criteria required a baseline score of 3 or 4. Patients were also assessed using the Eczema Area and Severity Index (EASI) and other measures. Patients were randomized into one of three treatment groups: dupilumab 300 mg subcutaneously once per week, dupilumab 300 mg subcutaneously every two weeks, or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo. Results at 16 weeks included the following:

For SOLO 1 and SOLO 2, respectively, 37 and 36 percent of patients who received dupilumab 300 mg weekly, and 38 and 36 percent of patients who received dupilumab 300 mg every two weeks , achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 10 and 8.5 percent with placebo (p less than 0.0001). This was the primary endpoint of the study in the U.S.
For SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received dupilumab 300 mg every two weeks, compared to 38 and 31 percent for placebo (p less than 0.0001).
For SOLO 1 and SOLO 2, respectively, 52.5 and 48 percent of patients who received dupilumab 300 mg weekly, and 51 and 44 percent of patients who received dupilumab 300 mg every two weeks, achieved EASI-75 compared to 15 and 12 percent with placebo (p less than 0.0001). This was the key secondary endpoint in the US for these studies and one of the primary endpoints in the EU.
For the 16-week treatment period, the overall rate of adverse events (65-73 percent dupilumab and 65-72 percent placebo) was comparable between the dupilumab groups and the placebo groups. The proportion of patients who completed the treatment period was 88-94 percent for dupilumab and 80.5-82 percent for placebo. The rate of serious adverse events was 1-3 percent for dupilumab and 5-6 percent for placebo. Serious and severe infections were also numerically higher in the placebo groups in both studies (0.5-1 percent dupilumab and 2-3 percent placebo). Adverse events that were noted to have a higher rate with dupilumab treatment across both studies included injection site reactions (10-20 percent dupilumab; 7-8 percent placebo), conjunctivitis (7-12 percent dupilumab; 2 percent placebo); approximately 26 percent of patients in both studies reported a history of allergic conjunctivitis at study entry. No patient discontinued therapy due to injection site reactions and only one patient discontinued therapy due to conjunctivitis.

More detailed results from SOLO 1 and SOLO 2 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.

The LIBERTY AD Phase 3 clinical program consists of five trials in patients with moderate-to-severe AD at sites worldwide.
More
Source: press release, 4/01/16. http://news.genzyme.com/press-release/sanofi-and-regeneron-announce-posi...

.