Theravance Announces Results From Phase II Clinical Study of TD-5108
Theravance announced positive results from its 400-patient ACCORD Phase II clinical study of TD-5108, a drug for chronic constipation.
In the study, all three doses of TD-5108 achieved statistical significance in the primary endpoint and key secondary endpoints. At the two lowest doses, TD-5108 was well-tolerated with a low incidence of adverse events, Theravance said.
All three doses of TD-5108 (15, 30 and 50 mg), given once daily, achieved the primary endpoint of an increased number of spontaneous bowel movements (SBM) per week over baseline compared with placebo, according to the company.
The average weekly increases over the four-week period in SBM from baseline for patients treated with TD-5108 were 3.6 for the 15-mg treatment group, 3.3 for the 30-mg group and 3.5 for the 50-mg group. The average weekly increase in SBM from baseline for patients on placebo was 1.4. The increase from baseline in SBM for each TD-5108 treatment group was also statistically significant compared with placebo for each week, the company said.
Over the four-week treatment period, 60 percent of the patients in the 15-mg treatment group, 42 percent of the 30-mg group, and 61 percent of the 50-mg group were classified as responders (patients who experienced at least three SBM for each of the four weeks), compared with 22 percent of patients on placebo; these results were statistically significant for all three groups, the company said.
Overall, the most common adverse events included headache, diarrhea, nausea and vomiting. The incidence of these adverse events was greatest at the highest dose of TD-5108. There were no serious adverse events in the study, the company said.