Theravance downplays mixed data in GI study
- Theravance Biopharma, Inc. announced Wednesday morning mixed results from its Phase 2b study of velusetrag (TD-5108) in patients with diabetic and idiopathic gastroparesis.
- The lowest dose of the drug tested, 5mg, had statistically significant results when compared with placebo, but the two higher doses, 15 mg and 30 mg, were not successful in the study.
- The 12-week study included 232 patients given either the drug or placebo via a once-daily oral dose. Patients were tested using the Gastroparesis Cardinal Symptom Index (GCSI) and the Gastroparesis Rating Scale (GRS) at both four weeks and 12 weeks.
Several years ago Theravance split off its highly lucrative respiratory business into a separate royalty-based company and decided to plod on with a new R&D engine.
Some of the efforts of that R&D-based biotech are now reaching later stages, but the once-hot biotech darling is no longer in favor.
The company irked some industry insiders when announcing the data for velusetrag, burying the fact that the two higher doses failed and that an analysis of all three doses did not return a statistically significant result.
"The lack of dose response resulted in a lack of statistical significance across the three doses when adjusted for multiplicity. As a result, the statistical comparisons for the 5 mg dose are not adjusted for multiple comparisons, and all are quoted as nominal," Theravance stated further down in its release.
Twitter did not take kindly to the presentation, with some spectators calling the company outright liars. Others, however, gave Theravance credit for at least acknowledging the lack of statistical significance for the higher doses.
The company attributed the poor results in the higher doses to an increased frequency of side effects, particularly rapid stomach emptying. Gastroparesis is characterized by delayed gastric emptying and gastric retention. The drug is meant to alleviate those symptoms. Yet, it seems that the gastric emptying that occurred in the higher doses was due to high rates of diarrhea and vomiting.
The company did note the two higher doses were statistically significant for the endpoint of gastric emptying time.
"We are very encouraged by the results of this study as they demonstrate not only consistent evidence of improved gastric emptying but also meaningful improvement in gastroparesis symptoms following treatment with 5 mg of velusetrag," said Brett Haumann, CMO of Theravance, in a statement. "We are now preparing to meet with regulators to discuss the next phase in our development plan."
The company will present full data at an upcoming medical meeting.
- Theravance Press release
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