In December, Vanda Pharmaceuticals gained FDA approval for its motion sickness drug Nereus. But a much larger patient population may be in store for the oral therapy as the Washington, D.C.-based company is testing it to prevent the nausea and vomiting that often accompany GLP-1 treatment.
Vanda is kicking off a placebo-controlled phase 3 trial, dubbed Thetis, which will evaluate the efficacy and safety of Nereus in patients receiving a high dose of a GLP-1 agonist. The primary endpoint is the proportion of patients free from vomiting episodes.
This study follows a successful phase 2 trial which featured a similar design as patients were pre-treated with Nereus or placebo before the addition of a 1 mg injection of Novo Nordisk’s GLP-1 Wegovy.
Results of the study, which were reported five months ago, showed that the trial met its primary endpoint as 29% of patients on Nereus plus Wegovy experienced vomiting compared to 59% of those on placebo plus Wegovy, representing a 50% relative reduction. The trial of 106 patients also achieved its key secondary endpoint with 22% of those in the Nereus group experiencing vomiting and nausea compared to 48% of those in the placebo arm.
“GLP-1 receptor agonists offer significant benefits but vomiting and nausea can severely impact patient adherence and quality of life,” Mihael Polymeropoulos, M.D., Vanda’s CEO, said in a release. “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.”
Vanda expects topline results from the phase 3 study to be available in the fourth quarter of this year.
Nereus is a neurokinin-1 (NK-1) receptor antagonist. Treatments from the drug class are used to prevent nausea and vomiting in patients who have had chemotherapy.
Nereus was approved for motion sickness based on three phase 3 trials, including two conducted on boats, which showed that it reduced nausea in participants with a history of motion sickness.
While Novo Nordisk’s semaglutide drugs Ozempic and Wegovy and Eli Lilly’s tirzepatide therapies Mounjaro and Zepbound have been transformative in the treatment of Type 2 diabetes and obesity, they also bring the potential to cause nausea, leading many users to discontinue treatment.
While semaglutide is a GLP-1 agonist, dual-action tirzepatide targets the GIP and GLP-1 incretin hormones that regulate blood sugar, insulin secretion and appetite.
Last month, the FDA approved a higher, 7.2 mg dose of Wegovy, above the previously endorsed maximum dose of 2.4 mg, bringing with it a greater chance of weight loss, along with the increased likelihood of nausea.
