(Kai Stachowiak, Pixabay)
12 September 2017. Results from a large-scale clinical trial show a synthetic antibody, when added to standard treatments, reduces asthma attacks and improves lung functioning. The drug, known as dupilumab, is being developed by drug makers Sanofi, based in Paris, and Regeneron Pharmaceuticals Inc., in Tarrytown, New York.
Asthma is chronic condition, where the airways become inflamed and narrow, causing people with asthma to experience wheezing, shortness of breath, tightness in the chest, and coughing for periods of time. Among asthma’s underlying causes are infections, pollutants in the air, and allergies to pollen, molds, or dust mites that trigger airway inflammation. Centers for Disease Control and Prevention estimates that in 2010 some 18.7 million adults had asthma, along with 7 million children.
The trial is testing dupilumab, a synthetic antibody that specifically targets the signaling protein interleukin 4, a modulator of signals driving type 2 helper T cells, a type of white blood cells triggering inflammatory immune system responses. Dupilumab was originally developed by Regeneron, then licensed to Sanofi for further development and commercialization. The drug is given as an injection under the skin.
The late-stage clinical trial recruited 1,902 individuals having asthma for more than 1 year, with separate samples of adults and adolescents, starting at age 12, at 413 sites worldwide. Participants were randomly assigned to receive injections of dupilumab every 2 weeks in doses of 200 or 300 milligrams, or equivalent doses of a placebo, taken with their current drugs for controlling asthma — inhaled corticosteroids and 2 other medications — for 1 year. The study team looked primarily for changes in the rate of severe exacerbations, or asthma attacks, over the year, as well as forced expiratory volume, the amount of air expelled in one second, after 12 weeks. Forced expiratory volume is an indicator of lung functioning.
The results show participants receiving the 300 milligram dupilumab dose reported 46 percent fewer severe asthma attacks than their counterparts receiving the placebo after 1 year, and greater improvement in forced expiratory volume, to 130 milliliters, after 12 weeks. In both measures, participants having higher eosinophil counts in their blood experienced lower severe exacerbation rates and higher forced expiratory volumes. Eosinophils are white blood cells in the immune system that help fight infections and inflammation.
Sanofi and Regeneron say results for participants receiving 200 milligrams of dupilumab were similar to the 300 milligram dose. More individuals receiving dupilumab (17%) experienced injection site reactions than placebo recipients (8%). Adverse events of all kinds and drop-outs from the study, whether or not related to the clinical trial, were comparable between dupilumab and placebo recipients.
The companies plan to submit dupilumab to the Food and Drug Administration for review as an asthma treatment by the end of the year. In March 2017, FDA approved dupilumab as a therapy for moderate-to-severe atopic dermatitis, skin inflammation also known as eczema, in adults, and is marketed under the brand name Dupixent.
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Hat tip: FirstWord Pharma
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