Theravance Biopharma Announces Initiation of Phase 2b Study of Velusetrag (TD-5108) for the Treatment of Gastroparesis
Gastroparesis is a significant medical condition characterized by delayed gastric emptying of food and associated with nausea, vomiting, early satiety, postprandial fullness and upper abdominal pain. The Phase 2b study (study 0099) is a multicenter, double-blind, randomized, placebo-controlled, parallel-group trial which will explore the efficacy and safety of multiple doses of velusetrag in patients with diabetic (n=100) or idiopathic (n=100) gastroparesis. Three dose levels of velusetrag (5, 15, and 30 mg once daily) will be evaluated and compared to placebo for 12 weeks of therapy. The primary endpoint will be the effect of velusetrag on symptoms in subjects with gastroparesis. The study will also evaluate the effect of velusetrag on gastric emptying, and the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure. The study will be conducted primarily in the US but will also include some European centers.
"Gastroparesis is a chronic and debilitating condition that causes significant patient suffering, and for which there are few therapeutic options. We believe that velusetrag may represent an important approach to treating this disease, which affects close to six million patients in the US alone," said
Velusetrag is being developed by
About Gastroparesis and Velusetrag
Gastroparesis is a disorder characterized by delayed gastric emptying and symptoms of gastric retention in the absence of mechanical obstruction. Approximately 36% and 29% of patients with gastroparesis have no known cause (i.e., idiopathic) or are diabetic, respectively. Post-prandial fullness, early satiety, bloating, abdominal discomfort (due to slow small bowel transit), nausea and vomiting are present in 46% to 97% of both diabetic and idiopathic gastroparesis patients with varying degrees of severity. Additional symptoms include weight loss and subsequent nutritional deficits.
The prevalence of gastroparesis in the US is estimated at 5.8 million, or 1.8% of the population. Among patients with diabetes, 14% of Type I and 9% of Type II diabetics (approximately 2 million individuals) seek care for gastroparesis. It is estimated that there are 188,000 US hospital discharges annually with a diagnosis of gastroparesis.
Velusetrag is an oral, once-daily investigational medicine discovered internally and developed for gastrointestinal motility disorders. It is a highly selective agonist with high intrinsic activity at the human 5-HT4 receptor.
5-hydroxytryptamine receptor 4 (5-HT4) agonists are established as gastrointestinal (GI) prokinetic agents for the treatment of GI tract dysfunction, such as chronic constipation. Velusetrag (or TD-5108) is a 5-HT4 receptor agonist that demonstrates high in vitro intrinsic activity and selectivity for the 5-HT4 receptor and has no significant affinity for all other receptor types, ion channels, or enzymes tested. Velusetrag is being evaluated for the treatment of GI motility disorders.
Velusetrag was shown to decrease gastric emptying time in normal volunteers after multiple doses. A Phase 2 study of velusetrag in 34 subjects with diabetic or idiopathic gastroparesis exhibited improvement in gastric emptying half times (GE t1/2) at doses of 5, 15, and 30 mg. The proportion of subjects demonstrating at least a 20% change from baseline in GE t1/2 was statistically significant for those subjects receiving velusetrag 30 mg and was noteworthy for those subjects receiving velusetrag 5 and 15 mg, compared to placebo. Similar treatment effects were observed in both diabetic and idiopathic gastroparetic subjects treated with velusetrag. Velusetrag has also been studied in patients with chronic idiopathic constipation (CIC), where velusetrag achieved statistically and clinically significant increases in stool frequency, including weekly frequency of spontaneous bowel movements (SBM) and weekly frequency of SBMs resulting in a sensation of complete evacuation (CSBM), versus subjects receiving placebo, in a Phase 2 study of 401 subjects during a 1 month study.
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