Amgen reported positive results from the Phase I study showing that inhibiting thymic stromal lymphopoietin (TSLP) could be useful in the treatment of asthma.
TSLP is a cytokine considered to be a key driver of the allergic inflammation that characterizes asthma. The placebo-controlled, double-blind, parallel-group study was intended as a proof-of-concept study to find out whether treatment with AMG 157 prevents allergen-induced airway responses in patients with allergic asthma. Results from the study involving 31 patients showed that treatment with AMG 157 resulted in statistically meaningful reductions in early asthmatic responses (EAR) and late asthmatic responses (LAR) in the airways following allergen challenges in patients with allergic (atopic) asthma. Study data also showed statistically significant decreases in baseline markers of inflammation in the airways.
“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 O'Byrne, executive director of the Firestone Institute for Respiratory Health, St. Joseph's Healthcare in Canada. O'Byrne added that the results support further development and investigation of AMG 157.
AMG 157 is a monoclonal immunoglobulin IgG2λ that inhibits TSLP activity. The compound is being co-developed by Amgen and AstraZeneca together with AZ’s biologics R&D arm MedImmune. AMG 157 is currently undergoing Phase 2 development as treatment for asthma.
“We are encouraged by these early results and look forward to leading further development of this promising new biologic in partnership with Amgen. The goal of the Phase 2 study is to understand if this approach could provide benefit for patients with severe asthma,” said Bing Yao, senior VP and head of MedImmune's Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit.
The data was published in The New England Journal of Medicine (NEJM).