Date: 2013-01-08
Type of information:
phase: 2
Announcement: initiation
Company: Theravance (USA) Alfa Wassermann (Italy)
Product: velusetrag (TD-5108)
Action mechanism: Velusetrag, also known as TD-5108, is a highly selective agonist with high intrinsic activity at the human 5-HT4 receptor. An oral, investigational medicine dosed once daily, velusetrag has completed a 400-patient Phase 2 proof-of-concept study in chronic idiopathic constipation, demonstrating statistically significant prokinetic activity at all three doses tested; at the two lowest doses, velusetrag was generally well tolerated with a low incidence of adverse events. Velusetrag has also been shown to accelerate gastric emptying in healthy volunteers. Velusetrag was discovered by Theravance through the application of its multivalent drug design in a research program dedicated to finding new treatments for gastrointestinal motility disorders.
Disease: diabetic or idiopathic gastroparesis
Therapeutic area: Gastroenterology - Digestive diseases
Country:
Trial details: Study 0093 is a multicenter, randomized, double-blind, incomplete block, three-period fixed sequence crossover, Phase 2 study. This proof-of-concept study will assess three oral doses of velusetrag (5, 15, and 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in approximately 32 patients with diabetic or idiopathic gastroparesis. The primary endpoint of the study is gastric emptying time. Secondary endpoints include safety and tolerability assessments.
Latest
news: Theravance and Alfa Wassermann have announced the initiation of a Phase 2 proof-of-concept study with velusetrag, Theravance\'s investigational 5-HT4 agonist, for the treatment of patients with diabetic or idiopathic gastroparesis. In October 2012 , the two companies have entered into a development and commercialization agreement for velusetrag, in development for gastrointestinal motility disorders. Under the agreement, the companies will collaborate in the execution of a two-part Phase 2 program, funded by Alfa Wassermann, to test the efficacy, safety and tolerability of velusetrag in the treatment of patients with gastroparesis.
