In December, Vanda Pharmaceuticals received FDA approval for its motion sickness drug Nereus. But more patients may be waiting for the oral treatment, as the Washington, D.C.-based company is testing it to prevent the nausea and vomiting associated with GLP-1 treatment.
Vanda has begun a placebo-controlled Phase 3 study called Thetis to evaluate the efficacy and safety of Nereus in patients receiving high doses of GLP-1 agonists. The primary endpoint was the proportion of patients free of emetic episodes.
The study follows a successful Phase 2 trial that featured a similar design in which patients were pretreated with Nereus or a placebo before adding a 1 mg injection of Novo Nordisk’s GLP-1 Wegovy.
Results from the study, reported five months ago, showed that 29% of patients taking Nereus plus Wegovy experienced vomiting, compared to 59% of patients taking Wegovy plus placebo, a relative 50% reduction, indicating the trial met its primary endpoint. The 106-patient trial also met key secondary endpoints, with 22% of patients in the Nereus group experiencing vomiting and nausea, compared to 48% of patients in the placebo group.
“GLP-1 receptor agonists offer significant benefits, but vomiting and nausea can severely impact patient adherence and quality of life,” Michael Polymeropoulos, MD, CEO of Vanda, said in the release. “Nereus has demonstrated strong antiemetic effects in previous clinical studies, and we are excited to advance this program that has the potential to improve tolerability and allow more patients to fully benefit from these important treatments.”
Banda expects primary results from the Phase 3 trial to be available in the fourth quarter of this year.
Nereus is a neurokinin-1 (NK-1) receptor antagonist. Treatments in this drug class are used to prevent nausea and vomiting in patients receiving chemotherapy.
Nereus was approved for motion sickness based on three Phase 3 trials, including two conducted on boats, and was shown to reduce nausea in participants with a history of motion sickness.
Novo Nordisk’s semaglutide treatments Ozempic and Wigovy, and Eli Lilly’s tirzepatide treatments Munjaro and Zepbound, have revolutionized the treatment of type 2 diabetes and obesity, but they can also cause nausea, causing many users to discontinue treatment.
Semaglutide is a GLP-1 agonist, while dual-acting tirzepatide targets the GIP and GLP-1 incretin hormones that regulate blood sugar, insulin secretion, and appetite.
Last month, the FDA approved a higher dose of Wegovy, 7.2 mg, above the previously approved maximum dose of 2.4 mg, which increases the chance of nausea and increases the chance of weight loss.
