New anti-inflammatory drugs! Sanofi/Regenerative Dollar Dupixent Treatment of Eosinophilic esophageal itis Phase III Clinical Success!

May 25, 2020 /
BiovalleyBIOON/ -- Sanofi and partner Regeneron recently jointly announced positive results for the evaluation of the new anti-inflammatory drug Dupixent (dupilumab) treatment for critical Phase III trials in patients aged 12The test struck two common primary endpoints and all key secondary endpoints at the same timeAccording to the study, Dupixent is the first and only biological agent to show positive and clinically significant results in Phase IIIclinical trialfor patients with EoE in the age group of 12 years of agePart B of the ongoing Phase III trial is evaluating an additional dosing regimen for DupixentEoE is a chronic progressive type 2 inflammatory disease that can damage the esophagus and prevent it from working properly, leading to difficulty swallowingIf left untreated, symptoms and inflammation may develop, leading to damage to esophagus function and scarringEoE can cause esophagus food plugs and requireimmediate visits to the emergency roomIn the Phase III trial, almost half of patients had surgery such as dilating the esophagus, and almost three-quarters had been treated with corticosteroidsIn the United States, about 160,000 EoE patients are currently being treated, of which about 50,000 have failed multiple treatmentsCurrently, there are no treatments approved by the FDA
the FDA in the case of EoEthe published Phase III trial, a randomized, double-blind, placebo-controlled trial, is evaluating the efficacy and safety of Dupixent's treatment of EoE adolescents and adults Part A of the trial was in groups of 81 EoE patients aged 12 years, who were identified by histology and patient reporting results In the study, patients were randomly assigned to receive a weekly subcutaneous injection of 300 mg of Dupixent (n? or placebo) or placebo (n-39) for continuous treatment for 24 weeks The common main endpoints are: relative baseline changes in the treatment of the 24th week of the DYPhy Stoic Ation Questionnaire (DSQ, a patient-reported dysphagia measurement tool), the proportion of patients with a peak in the count of eosinophils within the esophagus, 6 eos/hpf, esophageal inflammation measurement tool In some patients, the baseline DSQ score was 34, and the average baseline peak level of eothtic granulocytes was 89 eos/hpf results showed that from baseline to 24th week of treatment: (1) the Dupixent group had a 69% reduction in symptoms of disease, a 32% decrease in the placebo group (p-0.0002), and the symptoms of the disease were measured by the DSQ scale, which was a common primary endpoint of the study: on the 0-84 component scale, the Dupixent treatment group improved by 21.92 points and the placebo group improved by 9.60 points (2) In the Dupixent treatment group, 60% of patients with eosinophilic granulocytes decreased to a normal range and 5% in the placebo group, which was another common primary endpoint of the study (3) The abnormal results in the Dupixent group were reduced by 39% and the placebo group by 0.6%, as measured by the Endoscopy Reference Score (EoE-EREFS), with a decrease of 3.2 points in the Dupixent group and 0.3 points in the placebo group (p 0.0001) tests show edified that Dupixent's safety results were similar to those known in approved indications During the 24-week treatment period, the overall adverse incidence rates of Dupixent and placebo were 86% and 82%, respectively More common adverse events treated by Dupixent included injection site reactions (15 in the Dupixent group and 12 in the placebo group) and upper respiratory tract infections (11 in the Dupixent group and 6 in the placebo group) One patient in the Dupixent group was discontinued due to joint pain detailed results from the trial will be announced at the of the upcoming medical conference In the U.S., the FDA granted Dupixent the Eligibility for Orphan Drug (ODD) for EoE in 2017 Dr George D Yancopoulos, co-founder, president and chief scientific officer of Regeneration, said: "EoE is a debilitating disease and there is no approved treatment The disease affects a patient's ability to eat, causes severe pain, and often leads to repeated emergency room visits and medical procedures These data are particularly impressive because Dupixent not only significantly reduces eosinophils in the esophagus, but also improves all clinical, anatomical and histological indicators of the disease In the past, EoE was considered a disease caused by eosinophils, but other biologics that reduce esophageal eosinophils did not show consistent clinical or anatomical improvements These Dupixent results show that EoE is caused by multiple aspects of type 2 inflammation driven by IL-4 and IL-13 According to the Phase III trial, EoE is the fourth adhesion or type 2 inflammatory disease in which Dupixent has significant efficacy-critical trial data "These data show that Dupixent has the potential to continue filling the therapeutic gaps in the spectrum of type 2 inflammatory diseases, including common asthma and rare eosinophilic esophagitis," said Dr John Reed, Head of Global Research and Development at Sanofi This Phase III trial shows for the first time that patients report improved swallowing ability In some cases, patients with diet-constrained eosinophilic esophagealitis require repeated hospital interventions, and these findings are very encouraging "
a key driver of Dupixent targeting type 2 inflammation, a humanized monoclonal antibody that specifically suppresses over-activation signals for two key proteins IL-4 and IL-13 IL-4/IL-13 is two inflammatory factors that are considered to be key drivers of intra-inflammatory inflammation in allergic and other type 2 inflammatory diseases, including asexual dermatitis, asthma , acidophilic cytitis, grass allergy, peanut allergy, etc Dupixent was launched at the end of March 2017 as the world's first biological agent to treat moderate-severe asexual dermatitis To date, the drug has been approved by many countries and regions, including the United States, the European Union and Japan In the United States, Dupixent is now approved for the treatment of three diseases caused by type 2 inflammation: moderate to severe asexual dermatitis (patients aged 12), moderate to severe asthma (patients aged 12), and chronic nasal-sinusitis (CRSwWNP, adult patients) , Sanofi and Regeneration are also conducting an extensive clinical project to evaluate Dupixent's treatment of allergies and other type 2 inflammations, including: children asthma (6-11 years, stage III), child adhesion dermatitis (6 months to 5 years old, II Phase III), eosinophilic esophageal itis (phase III), chronic obstructive pulmonary disease (phase III), large herpes herpes (phase III), nodule itch (phase III), chronic spontaneous urticaria (phase III), food and environmental allergies (phase III) Dupixent is another important product that Sanofi and Regeneration have developed in partnership with pcSK9 inhibitor Praluent and are expected to be a game-changer Dupixent's indications are steadily increasing, with EvaluatePharma, a well-known pharmaceutical market research firm, predicting global sales of the drug could reach $8 billion by 2024 (biovalleybioon.com) original source: Dupixent? (dupilumab) Eosinophilicis Trial Meets Both Co-Primary Endpoints