Vanda Pharmaceutical’s Nereus may soon break out of its motion sickness niche to become a treatment option for the burgeoning GLP-1 market.
Topline results from the D.C.-based pharma’s phase 3 called “Study 3601” are in, and Nereus demonstrated a 27% reduction in vomiting among patients on GLP-1 receptor agonist therapy and a 35% reduction in severe nausea and vomiting.
Nausea and vomiting are among the biggest obstacles to GLP-1 adherence. Roughly half of patients quit the treatments within their first year, and gastrointestinal challenges are among their cited reasons. Vanda believes Nereus has the potential to help more patients stay on their therapy. Data in hand, the drugmaker is now heading for the FDA in hopes of a label expansion.
The placebo-controlled trial was designed to test Nereus under conditions that produce a high rate of vomiting. Patients were first dosed with either Nereus or placebo. Then all patients were given a single 1 mg dose of Wegovy without the gradual titration used in clinical practice so to have a stronger vomit-inducing effect.
The study met its primary endpoint, with Nereus significantly reducing any incidence of vomiting. Among the patients treated with Nereus, 43% experienced vomiting compared to 58.5% in the placebo group.
Severe vomiting and nausea were the secondary endpoint, and Nereus reduced these episodes with 33.1% of patients on Nereus versus 50.6% in the placebo group experiencing severe gastrointestinal symptoms.
In a post-hoc analysis, Nereus also reduced high intensity vomiting patterns. Only 6.3% of patients on Nereus experienced frequent vomiting—defined as three or more vomiting episodes on more than one day—compared to 15.9% on placebo, a 60% reduction.
Nereus also appeared to drive an 81% reduction in extreme vomiting, defined as more than 10 total episodes after the GLP-1 treatment, with 2.8% in the Nereus group versus 14.6% in the placebo experiencing the severe reaction.
“Nereus can meaningfully reduce vomiting and frequent multi-day vomiting induced by GLP-1 therapy, which are key contributors to treatment discontinuation,” Vanda’s CEO Mihael H. Polymeropoulos, M.D., said in a statement. “The consistency and magnitude of the effects observed across this program could offer significant benefit to the millions of people seeking or using GLP-1 therapies.”
An NK-1 receptor antagonist, Vanda earned its inaugural FDA approval for motion-induced vomiting in December. Other members of the drug class are also used to treat nausea and vomiting caused by chemotherapy.