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The New England Journal Of Medicine Publishes Positive Proof-Of-Concept Data For New Asthma Treatment
Results from the 31-patient study showed treatment for 12 weeks with AMG 157, a monoclonal antibody that inhibits the activity of TSLP, resulted in statistically significant reductions in early asthmatic responses (EAR) and late asthmatic responses (LAR) in the airways following allergen challenges in patients with allergic (atopic) asthma. The data also showed statistically significant decreases in baseline markers of inflammation in the airways. Overall, adverse events were similar across treatment and placebo groups (15 events in the treatment arm versus 12 events in the placebo arm), with no serious adverse events occurring in the study.
"While these data are very early, they help to confirm our belief that TSLP is a critical early mediator that may be responsible for persisting airway inflammation and triggering the inflammatory response to allergens in allergic asthmatic patients," said Paul M. O'Byrne, MB, FRCPC, FRSC, executive director of the
AMG 157 is a monoclonal immunoglobulin IgG2λ that binds to and inhibits TSLP from interacting with its receptor. TSLP is a cytokine that is believed to play a critical role in the start of the allergic cascade, specifically the inflammatory response, and is generated by lung tissue when an allergen is introduced. Studies have also shown higher amounts of TSLP were produced in the lung tissue of individuals with asthma compared to healthy individuals, and the TSLP gene has been associated with both childhood and adult allergic asthma.
"Understanding the underlying biology of disease is critically important to continuing to discover novel treatments for patients suffering from a variety of diseases," said
MEDI9929/AMG 157 is being jointly developed by
"We are encouraged by these early results and look forward to leading further development of this promising new biologic in partnership with
The double-blind, placebo-controlled parallel-group study was conducted as a proof-of-concept study to determine whether treatment with AMG 157 prevents allergen-induced airway responses in patients with allergic asthma. Thirty-one participants who developed EAR and LAR were enrolled and randomized to AMG 157 (n=16) or placebo (n=15). Participants received three doses of AMG 157 (700 mg intravenously) or placebo, four weeks apart. Allergen challenges were conducted on days -14, 42 and 84.
Detailed results from this trial were published in NEJM and can be viewed here.
An estimated 300 million people worldwide have asthma, a chronic inflammatory disease of the airways, characterized by recurrent episodes of wheezing, breathlessness, chest tightness and cough. Approximately 70 percent of asthma patients also have allergies. Allergic asthma is caused in part by a genetic tendency to develop allergic diseases, typically associated with heightened immune responses to common allergens, especially inhaled allergens and food allergens. Allergen inhalation by atopic asthmatics causes symptoms including reversible airflow obstruction, airway hyperresponsiveness, and airway inflammation.
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 As part of the collaboration agreement, the compound reference number has been changed from AMG 157 to MEDI9929/AMG 157. Phase 2 clinical studies are referenced on clinicaltrials.gov under MEDI9929 or AMG 157.