#United States #Washington #Vanda Pharmaceuticals #GLP-1 therapies #NEREUS™

Vanda Pharmaceuticals Initiates Thetis Study

Vanda Pharmaceuticals Inc. has officially launched the Thetis Study, a clinical trial aimed at assessing the efficacy of its drug NEREUS™ (tradipitant) in preventing vomiting related to GLP-1 receptor agonist therapies. This initiative is particularly significant for patients undergoing treatment for type 2 diabetes and obesity, which often includes medications that may induce gastrointestinal side effects.

Background

GLP-1 receptor agonists, such as semaglutide and tirzepatide, have revolutionized the management of type 2 diabetes and obesity due to their effectiveness in improving glycemic control and promoting weight loss. However, these medications can induce nausea and vomiting, leading to treatment discontinuation or dosage reduction in many patients. For instance, recent FDA approvals for an increased dosage of Wegovy highlight the concerning relationship between higher doses and the exacerbation of nausea and vomiting.

The Thetis Study

The Thetis trial is designed as a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the oral administration of tradipitant in patients who are starting a high dose of a GLP-1 receptor agonist. The primary objective of this study is to identify the percentage of patients who will experience no episodes of vomiting throughout the treatment phase.

Previously, a Phase 2 study indicated promising results, where a significant reduction in vomiting was observed among patients pre-treated with tradipitant prior to a typical 1 mg injection of Wegovy. Notably, only 29.3% of those receiving tradipitant experienced vomiting compared to 58.6% in the placebo group—a remarkable relative reduction of 50%. Furthermore, the study succeeded in its key secondary endpoint of significantly lowering the incidence of both vomiting and substantial nausea.

Comments from Leadership

Dr. Mihael H. Polymeropoulos, President and CEO of Vanda Pharmaceuticals, emphasized the importance of this trial by stating, "GLP-1 receptor agonists offer significant benefits, but vomiting and nausea can severely impact patient adherence and quality of life. NEREUS™ has demonstrated potent antiemetic effects in prior clinical studies. We are excited to advance this program, which has the potential to improve tolerability and allow more patients to fully benefit from these important therapies."

Future Expectations

Vanda anticipates receiving topline results from this study by the fourth quarter of 2026. Following the completion of Thetis, additional research may be necessary before filing a New Drug Application (NDA) for NEREUS™.

About NEREUS™

NEREUS™ (tradipitant) is a neurokinin-1 receptor antagonist acquired by Vanda from Eli Lilly and Company. Currently, it is approved for preventing vomiting caused by motion sickness and is under development for other indications, including gastric problems and nausea linked to GLP-1 receptor agonists.

For more information about NEREUS™, you can visit the official website at NEREUS.

Conclusion

With the initiation of Thetis, Vanda Pharmaceuticals is taking crucial steps toward improving patient experiences for those undergoing GLP-1 receptor agonist therapy. The company's innovative approach could significantly impact treatment adherence, promoting better health outcomes for individuals living with type 2 diabetes and obesity.