P2032 - Tradipitant, a Novel Neurokinin-1 Receptor Antagonist, Showed Continued Improvement in Nausea and Other Symptoms Associated with Gastroparesis in an Open-Label Extension of a Phase II Clinical Trial
Introduction: Tradipitant is a novel NK-1 receptor antagonist that has previously showed efficacy in diabetic and idiopathic gastroparesis in reducing nausea, vomiting and overall gastroparesis symptoms in a phase 2 study compared to placebo. After completing the 4-week randomized, double-blind, placebo-controlled phase, patients were invited to enter an open-label extension (OLE) phase where they received 85mg tradipitant BID for an additional 8 weeks. The aim of the OLE was to assess the effect of tradipitant in improving nausea and overall symptoms in patients with gastroparesis. Here we report the results of this 8 week OLE portion of the phase 2 study that assessed the symptoms of gastroparesis.
Methods: Idiopathic and diabetic gastroparesis patients with moderate to severe nausea, who completed the 4-week double-blind phase received 85mg tradipitant BID open label for 8 weeks (n=93). Clinical symptoms were measured by the Gastroparesis Core Symptom Daily Diary (GCSDD) and the Gastroparesis Cardinal Symptom Index (GCSI) questionnaire. Symptom improvements are presented as change from original baseline and change from OLE baseline as measured by the daily diary and GCSI. Symptom improvement was also compared between respective active and placebo groups from the double-blind phase.
Results: The combined mean (SD) change in average daily nausea from baseline to week 8 of OLE was -1.74 (1.263, p< 0.0001). The mean (SD) change in average daily nausea from baseline to week 8 of OLE was -1.78 (1.116) for patients who originally received tradipitant and was similar to -1.71 (1.389) in patients who originally received placebo. The combined mean (SD) change in the weekly percentage of nausea free days from baseline to week 8 of OLE was 43.83% (39.31%, p< 0.0001). The mean percentage (SD) of nausea free days improved in patients originally assigned tradipitant or placebo by 48.13% (36.57%) and 40.24% (41.61%) respectively.
Discussion: Efficacy established by tradipitant in the 4-week double-blind phase was persistent, while patients originally assigned to placebo in the double-blind phase saw similar benefits from tradipitant during the OLE phase. Treatment with tradipitant continued to be effective in improving nausea and overall symptoms in patients with gastroparesis and was safe and well tolerated during the OLE of the study.
Jesse Carlin, PhD, Michaela Fisher, BS, Meredith Bagger, BS, Darby Madonick, BS, Caleigh Kupersmith, BA, Miren Lopez Lascurain, BS, Changfu Xiao, PhD, Gunther Birznieks, MS, Mihael Polymeropoulos, MD, PhD. P2032 - Tradipitant, a Novel Neurokinin-1 Receptor Antagonist, Showed Continued Improvement in Nausea and Other Symptoms Associated with Gastroparesis in an Open-Label Extension of a Phase II Clinical Trial, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.