The drug, TD-5108, is designed to treat chronic constipation and other disorders related to reduced gastrointestinal (GI) motility.
Theravance says 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.
All three doses of TD-5108 (15mg, 30mg, and 50mg), given once daily, achieved the primary endpoint of an increased number of spontaneous bowel movements (SBM) per week over baseline compared with placebo.
Over the four-week treatment period, 60% of the patients in the 15mg treatment group, 42% of the 30mg group, and 61% of the 50mg group were classified as responders (patients who experienced at least three SBM for each of the four weeks), compared with 22% of patients on placebo; these results were statistically significant for all three groups.
Compared with placebo, the company says there was a statistically significant reduction in time to first SBM and a statistically significant increase in the percentage of patients who experienced an SBM within the first 24 hours for all groups treated with TD-5108.
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.
“There is a substantial unmet medical need for a medicine to treat patients with chronic constipation and other motility disorders of the GI tract,” claims Michael Kitt, senior vice president of development at Theravance. “We look forward to meeting with the FDA to discuss the development path for TD-5108.”