2022-07-15| Trials & Approvals

Sanofi and Regeneron Post Positive Results from Child Throat Disease Trial

by Reed Slater
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Riding a wave of recent approvals for blockbuster allergic disease medicine, Dupixent, Sanofi and Regeneron are eyeing another indication after announcing positive results from a Phase 3 trial evaluating the drug to treat eosinophilic esophagitis (EoE) in patients between one and 11 years old. 


A Unique Approach to Allergy Disease Treatment


Dupixent is an injected monoclonal antibody that inhibits the signaling of the cytokines IL-4 and IL-13, which are key players in type 2 inflammatory responses. Unlike some other allergy disease treatments, Dupixent is not an immunosuppressant. 

EoE is a chronic allergic immune condition caused by the build-up of white blood cells called eosinophils in the esophagus. The rare disease can result in inflammation of the esophagus, making it hard to swallow and increasing the chances of choking. Other effects of EoE include abdominal pain, vomiting, and refusal to eat, which can lead to growth problems in young children. 

Studying treatments in children is difficult because of the size and weight difference among children between one and 11 years old, so the Phase 3 clinical trial provided weight-dependent doses for the 102 participants. Children may also have difficulty explaining their symptoms, so the trial relied on caregivers to describe symptoms. 

With the constraints in mind, Sanofi and Regeneron announced that the clinical trial met the primary endpoint, with 68% of children on a high dose and 58% on a low dose achieving histological disease remission as opposed to 3% for placebo. Additionally, throughout the 16-week trial, children who received a high dose experienced an 86% decrease in eosinophils compared to a 21% increase for placebo. 

Regeneron and Sanofi will discuss more details about the trial at an upcoming medical meeting. The trial will consist of a 36-week extended active treatment period to evaluate long-term safety and efficacy outcomes. 

Related Article: FDA OKs First Biologic for Children Under 5 With Moderate-to-Severe Atopic Dermatitis


Keeping the Ball Rolling for Dupixent


The positive trial results are just another notch in the belt for Dupixent’s development after two additional indication approvals in 2022. In May, the FDA approved Dupixent to treat EoE in adults and children over 12 who weigh more than 40 kilograms. In June, Dupixent received FDA approval to treat children between six months and five years old with moderate-to-severe atopic dermatitis who have already tried or cannot use other topical treatments. 

While 2022 has been an active year, Dupixent’s success has grown rapidly since its first approval in 2017. According to Sanofi’s 2021 annual report, Dupixent accounted for €5.2 billion in net sales. Atopic dermatitis treatment drives most of the sales, but other indications in asthma, chronic rhinosinusitis with nasal polyps, and EoE provide support.

Outside of America, Dupixent is available in over 60 countries. In April, the drug received approval from the European Commission to treat children between six and 11 years old with severe asthma and type 2 inflammation. 

The two companies continue developing Dupixent for more indications. Phase 3 trials are ongoing evaluating Dupixent for the treatment of prurigo nodularis and chronic obstructive pulmonary disease. 

Sanofi and Regeneron struck gold co-developing Dupixent, and all the research and development is paying off ten-fold just five years after its initial approval. Positive results from its most recent clinical trial might set a precedent for an ever-widening scope for the drug. 

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