Vanda Pharmaceuticals initiates trial of tradipitant in GLP-1-caused vomiting

Vanda Pharmaceuticals (VNDA) announced the initiation of Thetis, a clinical trial evaluating Nereus – tradipitant – for the prevention of vomiting in patients receiving glucagon-like peptide-1, or GLP-1, receptor agonist therapies. Nereus was recently approved for the prevention of vomiting induced by motion. GLP-1 receptor agonists have transformed the treatment of type 2 diabetes and obesity. However, gastrointestinal side effects, particularly nausea and vomiting, remain a significant challenge for many patients and are a leading cause of treatment discontinuation or dose reduction. The Thetis study will evaluate the efficacy and safety of oral tradipitant in patients initiated at a high dose of a GLP-1 receptor agonist. The primary endpoint is the proportion of patients free from vomiting episodes during the treatment period. The phase 2 study met its primary endpoint, with only 29.3% of tradipitant-treated participants experiencing vomiting compared to 58.6% on placebo, representing a 50% relative reduction. Vanda expects topline results from the Thetis study by Q4. Following completion of the Thetis study, additional study data may be required prior to approval of a NDA.