In a most recent announcement, Regeneron Pharmaceuticals and French pharmaceutical giant Sanofi said that a one-year Phase 3 study, called LIBERTY AD CHRONOS, analyzing investigational dupilumab has met its main and key secondary endpoints.
During the study, researchers compared dupilumab having topical corticosteroids (TCS) with TCS solely in adults suffering from moderate-to-severe atopic dermatitis (AD).
The participating patients were inadequately controlled by topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI). Researchers observed that dupilumab with TCS notably made the measures of overall disease severity better at 16 and 52 weeks, in comparison to placebo with TCS.
George D. Yancopoulos, MD, PhD, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, said, “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”.
Yancopoulos added that though topical corticosteroids were typical therapies for atopic dermatitis, they were non-specific anti-inflammatory agents, where as dupilumab is a specific therapy that particularly blocks the IL-4/IL-13 signaling pathway.
Yancopoulos mentioned that their collective clinical data has shown that the pathway was the main culprit in atopic dermatitis, asthma and nasal polyposis. They have been evaluating the pathway’s potential in such atopic and allergic diseases.
Elias Zerhouni, MD, President, Global R&D, Sanofi, called dupilumab an innovative first-in-class investigational agent to show notable efficacy and a positive safety profile in both crucial Phase 3 studies in monotherapy for patients of moderate-to-severe atopic dermatitis, and presently in concomitant administration with topical corticosteroids.
Zerhouni mentioned that the one-year data has strongly backed the earlier 16-week findings, indicating that dupilumab plays a part in the aberrant activation of the IL-4/IL-13 pathway, resulting into notable efficacy in the absence of any side effects linked to immune-suppressing therapies.
According to a story published on the topic by Reuters, “French drugmaker Sanofi SA and U.S. partner Regeneron Pharmaceuticals Inc said a one-year, late-stage study of dupilumab, a monoclonal antibody designed for the treatment of skin diseases, had met its main goals.”
“These are 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,” Regeneron Chief Scientific Officer George D. Yancopoulos said in a statement.
Sanofi said in the statement that the partners planned their first submission for regulatory approval for the treatment in the United States in the third quarter of this year.
“French drug giant Sanofi (SAN.FR) and U.S. partner Regeneron Pharmaceuticals REGN, -1.57% said a one-year phase three trial study showed a treatment combining their drug dupilumab with topical corticosteroids significantly improved the situations of a group of patients suffering from atopic dermatitis,” according to a news report published by Market Watch.
The treatment including dupilumab improved the overall severity of the disease for patients whose atopic dermatitis was inadequately controlled by a treatment of just topical corticosteroids, the companies said Monday.
Large pharmaceutical labs like Sanofi are rushing to develop new drugs to replace a number of existing drugs that are entering the public domain, which would allow generic pharmaceutical groups to produce and sell the same drugs at a fraction of the current price, a phenomenon known as the “patent cliff.”
A report published in Nasdaq said, “The U.S. FDA granted dupilumab Breakthrough Therapy designation in atopic dermatitis 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 of patients with moderate-to-severe atopic dermatitis at sites worldwide.