Theravance Inc. recently announced positive top-line results on TD-1211 from a phase IIb study, 0084. TD-1211 is an oral peripherally selective mu-opioid receptor antagonist (PμMA) being developed for the treatment of opioid-induced constipation (OIC) in patients suffering from chronic non-cancer pain. The company expects to move the candidate into phase III development based on these results.
The phase IIb program evaluated doses and dosing regimens for phase III trials. The phase IIb program comprises three studies 0074, 0076 and 0084. The 5-week, randomized, double-blind key study 0084 enrolled 217 patients and compared TD-1211 in 5 mg, 10 mg and 15 mg dosages versus placebo.
TD-1211 demonstrated significant benefit in complete spontaneous bowel movements (CSBMs) from the baseline average of 0.1 to 0.3 CSBMs per week and met the primary efficacy endpoint for all doses. The candidate was found to be well tolerated. The treatment-emergent adverse event was 39%-55% for TD-1211 and 44% for placebo.
In the phase IIb program, study 0074 evaluated the frequency and severity of treatment-emergent adverse events in patients with OIC and study 0075 is evaluating the safety and tolerability profile of TD 1211. Detailed data from the three studies are expected to be presented in upcoming medical conferences.
The OIC market currently is insufficiently served by laxatives. Many patients do not show adequate response to laxative treatment. Salix Pharmaceuticals, Ltd./Progenics Pharmaceuticals’ /(PGNX - Free Report) Relistor, a subcutaneous injection, is currently approved for the treatment of OIC in patients with advanced illness who are receiving palliative care and do not show sufficient response to laxative therapy.
We currently have a Neutral recommendation on Theravance. The stock carries a Zacks #2 Rank (Buy rating) in the short run. We are impressed by Theravance’s efforts to develop its pipeline. We believe that the Relovair, LABA/LAMA and MABA combination programs, in collaboration with GlaxoSmithKline (GSK - Free Report) , hold immense potential and could bring significant royalties to the company.
However, we remain concerned by the challenges faced by Theravance regarding Vibativ supplies following the termination of its deal with Astellas. Moreover, the Committee for Medicinal Products for Human Use’s (CHMP) recommendation to suspend the marketing approval for Vibativ for the nosocomial pneumonia (NP) indication in the EU is another setback for the company.