Greer has launched a Phase III trial for sublingual-oral immunotherapy (SLIT) for adults with rhinoconjunctivitis caused by short ragweed pollen. Greer is the first U.S. allergy company to initiate a Phase III trial for the oral administration of liquid standardized allergenic extracts.
The company based in Lenoir, NC, recently reported positive results for its Phase IIb trial using SLIT short ragweed extract to reduce allergy symptoms and the need for anti-allergy medications during ragweed season.
SLIT is widely accepted as a safe, effective treatment for allergic rhinitis in Europe. However, the allergenic extracts used for SLIT in Europe differ from the allergen products expected to be approved in the United States. The aim of the Phase III trial is to support changes in labeling for Greer's currently licensed short ragweed allergenic extract.
"This trial is pivotal in Greer's efforts to bring SLIT to the United States," says John Roby, Greer President and CEO. "Much of the allergy specialty community's hesitation to embrace sublingual-oral immunotherapy has stemmed from the lack of data evaluating U.S. licensed allergenic extracts and FDA approval. Our hope is that this study will clearly show the role SLIT can play in improving allergy care and position Greer as a leader in bringing this delivery method to the United States."