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ARTICLE | Clinical News

TD-1211: Phase IIb data

July 16, 2012 7:00 AM UTC

Top-line data from the 5-week, double-blind Phase IIb Study 0084 trial in 217 OIC patients with chronic, non-cancer pain showed that 5, 10 and 15 mg doses of oral TD-1211 each met the primary endpoint of increasing mean CSBMs per week over the last 4 weeks vs. placebo. Specifically, TD-1211 increased mean CSBMs per week over the last 4 weeks from baseline by 1.5 CSBMs at the 5 mg dose (n=53; p=0.0413), 2.7 CSBMs at the 10 mg dose (n=49; p=0.001) and 2.5 CSBMs at the 15 mg dose (n=47; p=0.0003) vs. 0.8 CSBMs for placebo (n=52). Mid- and high-dose TC-1211 also met the secondary endpoint of increasing the number of mean SBMs over the last 4 weeks of treatment from baseline vs. placebo. Specifically, TD-1211 increased SBMs from baseline over the last 4 weeks by 3.4 SBMs at the 10 mg dose (p=0.0038) and 3.7 SBMs at the 15 mg dose (p=0.0003) vs. 1.9 SBMs for placebo. Low-dose TD-1211 produced a non-significant increase of 2.7 SBMs on the endpoint (p=0.0739).

Additionally, TD-1211 produced a response, defined as >=3 SBMs per week with an increase of >=1 SBM per week from baseline for >=3 of the last 4 weeks, in 59% of patients receiving the 5 mg dose (p=0.0401), 61% of patients receiving the 10 mg dose (p=0.0222) and 70% of patients receiving the 15 mg dose (p=0.0016) vs. 39% of patients receiving placebo. Theravance said an identical analysis using CSBMs showed that the response rate was significant with mid- and high-dose TD-1211. Furthermore, 66% of patients receiving high-dose TD-1211 reported that their constipation was "better" or "much better" on a 7-point global impression of change scale at 5 weeks compared to baseline, a secondary endpoint, vs. 21% for placebo (p<0.0001). Theravance said that 5 and 10 mg TD-1211 were also significant on the endpoint. The most common adverse events were abdominal pain, nausea, diarrhea and headache. ...