- Results from a Phase 2b clinical trial assessing Theravance Biopharma's (NASDAQ:TBPH) velusetrag (TD-5108) for the treatment of patients with diabetic and ideopathic gastroparesis showed statistically significant improvements in symptoms and gastric emptying compared to placebo in patients receiving the 5 mg dose.
- The 232-subject study evaluated three doses of velusetrag (5 mg, 15 mg and 30 mg) and placebo administered orally once per day for four weeks. In the 5 mg cohort, statistically significant improvements in two rating scales, GCSI and GRS, and gastric emptying time were maintained through 12 weeks of treatment.
- The 15 mg and 30 mg groups did not experience statistically valid improvements in symptoms. The company says this could have been the result of an increased frequency in GI side effects that may have been caused by rapid emptying of the stomach, substantiated by the highly statistically significant difference in gastric emptying time versus placebo for both doses (p<0.001).
- On the safety front, rates of adverse events (AEs) and serious adverse events were comparable between 5 mg of velusetrag and placebo. The most common AEs were diarrhea, nausea and headache.
- The company plans to discuss the data with regulators as it prepares to advance velusetrag into the next phase of development.
- The data will be submitted for presentation at upcoming medical conferences and for publication.
- Fast Track-tagged velusetrag is an agonist of the 5-HT4 receptor, a metabotropic receptor that plays a key role in GI tract function.
- Previously: Theravance's velusetrag performs well in gastroparesis study (May 18, 2015)
- Now read: Momenta Pharmaceuticals EPS in-line, misses on revenue
Original article