Vanda Pharmaceuticals has reported positive results from the Phase III clinical trial, Study 3601 (VP-VLY-686-3601), assessing its oral therapy Nereus (tradipitant) for the prevention of vomiting triggered by glucagon-like peptide-1 (GLP-1) receptor agonist treatments.
The placebo-controlled, randomised study showed marked reductions across overall, frequent, and severe vomiting episodes.
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Following the trial, Vanda intends to review the combined findings from its Phase II and Phase III programmes with regulators and plans to submit a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to support tradipitant for this indication.
The trial tested the therapy, which operates as a neurokinin-1 receptor antagonist, under elevated emetogenic conditions by administering participants a single 1mg dose of semaglutide without standard clinical titration.
Across the trial population, 43.0% of patients receiving Nereus (61/142) reported vomiting compared with 58.5% on placebo (96/164), representing a site-adjusted relative reduction of 27%.
For the key secondary outcome measuring vomiting alongside severe nausea graded at 3 or above, incidence reached 33.1% in the tradipitant arm (47/142) against 50.6% in the placebo cohort (83/164), an adjusted 35% relative decrease.
Exploratory post-hoc assessments indicated substantial declines in higher-intensity vomiting patterns.
Frequent vomiting, defined as exceeding two events on more than one day, occurred in 6.3% of participants on tradipitant versus 15.9% on placebo, reflecting a 60% relative reduction.
Extreme vomiting of more than ten total episodes dropped by 81%, occurring in 2.8% of tradipitant recipients compared with 14.6% on placebo, consistent with an approximate 80% decrease recorded during Phase II testing.
Most vomiting occurred by day two, with incidence peaking on day one.
Vanda president, CEO and board chairman Dr Mihael Polymeropoulos said: “These results demonstrate that Nereus can meaningfully reduce vomiting and frequent multi-day vomiting induced by GLP-1 therapy, which are key contributors to treatment discontinuation.
“The consistency and magnitude of the effects observed across this programme could offer significant benefit to the millions of people seeking or using GLP-1 therapies.”
In May 2024, Vanda Pharmaceuticals reported positive outcomes from its second Phase III clinical trial of tradipitant, aimed at treating motion sickness.
