For the first time, Sanofi/Regenerative Dupixent showed significant signs of improving eosinophilic esophedritis

On October 26th, Regenerative And Sanofi announced more positive results for the evaluation of Dupixent® (dupilumab) for the treatment of patients aged 12 and older with EoE in a critical Phase 3 clinical trial, Part A, at the annual meeting of the American Academy of Gastroenterology (ACG) and the European Federation of Gastroenterology (UEG) 2020.
previously released by the U.S. Government showed that the trial reached both the primary and all key secondary endpoints.
the latest data show a further improvement in the severity and progress of the disease at the microscopic level, as well as normalization of gene expression patterns associated with type 2 inflammation.
previously published results showed Dupixent improved EoE's symptoms, structure and histological indicators, the company said.
the current use of Dupixent to treat EoE is still in the investigative research stage and has not yet been fully evaluated by any regulatory body.
a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluated Dupixent's effectiveness and safety in adolescents and adults.
Based on histological and patient-reported measurements, the trial involved 81 EoE patients aged 12 and over (42 of whom were treated with Dupixent and 39 with placebo), 85 percent of whom also had an allergic disease.
24-week treatment period, patients receive 300 mg of Dupixent treatment or placebo per week. The common main endpoint of the
trial was to assess changes in dysphagia symptom questionnaires (DSQ), the degree of difficulty reported by patients, and the proportion of patients who reached a peak in the count of eos/hpf (eos/hpf≤( an indicator of esophephpathy inflammation) at 24 weeks. The primary secondary endpoint of the
trial assessed histopathological indicators of the severity and progression of scarring in esophageal tissue, such as EoE-HSS grading and phased scoring, and the proportion of patients who reached the peak eos/hpf count at 24 weeks.
secondary endpoints of the trial assessed the relative changes in the Standardized Richness Score (NES) from baseline to week 24 in EoE diagnosis and the characteristics of the type 2 inflammatory transcription group.
latest results from
show that patients treated with Dupixent experienced rapid improvements in swallowing ability and comfort: patients reported significant improvements in their DSQ as early as 4 weeks of treatment and continued improvements within 24 weeks (p.lt;0.05 and p.lt;0.001, respectively).
esophageal acidophil count was reduced below the disease diagnosis threshold: within 24 weeks, 64% of patients in the Dupixent treatment group reached 15 eos/hpf, while the placebo group reached 8% (p.lt;0.001).
, the peak count of esophageal ephedal cells in the Dupixent group decreased by 71% from the baseline level compared to the placebo group.
Reduce the severity and progression of the disease at the microscope level: at 24 weeks, the esoesopathic tissue change grading and phased scores of patients in the Dupixent group decreased by 0.761 and 0.753, respectively, compared to the placebo group;
normalized gene expression in eso pipe tissue: From baseline examination to 24 weeks, the dupixent treatment group had 1.97 times and 2.66 times fewer gene expression patterns associated with type 2 inflammation and EoE, and 0.32 times and 0.16 times less placebo groups, respectively, through NES measurements.
NES evaluated a group of genes associated with type 2 inflammation or EoE (all values were p-lt;0.001).
by the Dupixent group suggests that gene expression patterns have shifted from patterns similar to EoE's to healthy-controlled patterns.
, the trial demonstrated that Dupixent is similar to the safety it establishes in approved adaptations.
24 weeks of treatment, the adverse events of the drug and placebo were 86% and 82%, respectively.
more common adverse reactions to the use of Dupixent include injection site reactions (Dupixent n=15, placebo n=12) and upper respiratory tract infections (Dupixent n=11, placebo n=6).
1 case in the Dupixent group was discontinued due to joint pain.
it is known that there is currently no FDA-approved treatment for EoE, a chronic and aggressive inflammatory disease that damages the esoviran and prevents it from working properly.
over time, excessive type 2 inflammation can lead to esophageal scarring and stenosis, making swallowing difficult.
EoE can affect a patient's ability to eat and cause food to get stuck after swallowing (food plugs), leading to medical first aid.
as the main growth driver for Sanofi and Regenerative, Dupixent is a best-selling drug that has received three approvals, and the strategy of both drugmakers is to achieve sustained growth through multiple clinical adaptations.
In June 2020, the two partners outlined Dupixent's next clinical development plan, including clinical trials for EoE, chronic obstructive pulmonary disease (COPD), nodding itch, chronic spontaneous urticaria, and large herpes-like herpes.
The fastest progress so far is two Phase 3 trial data on nodding itching, which causes hard, itchy lumps on the skin that the FDA has not yet approved.
said the latest data from the study would be released as soon as the second half of 2021 and an application for approval would be submitted by the end of the year.
earlier this year, two pharmaceutical companies joined a group of 240 patients with chronic spontaneous urticaria for Dupixent treatment in clinical trials and hope to submit approval data for EoE and chronic spontaneous urticaria by 2022.
addition, Sanofi and Regeneration also plan to submit regulatory approval documents for herpes-like herpes and COPD in 2023 and 2024, respectively.
companies will maintain their 50-50 revenue share.
February, Sanofi CHIEF Executive Paul Hudson predicted that Dupixent could eventually achieve $10.97 billion in annual sales after achieving $2.56 billion in sales in 2019.
February, SVB Leerink forecast Dupixent's sales of $3.84 billion this year and $10 billion in 2026, respectively.
long-term forecast is 10 to 15 per cent higher than widely expected.
source: 1. Sanofi, Regeneron chase 4th Dupixent approval with rare esophageal disease data2. Dupixent ® Late-breaking Pivotal Data Show Major Major In Eosinophilic Esophagitis Signs and Symptoms Presented for The First At Scientific Meetings