With that I will turn the call over to Mathai Mammen, who will discuss results of the Phase 2 study with TD-1211.
I’m very excited to review the top line results from our Phase 1 and Phase 2 clinical studies of TD-1211. Before I discuss the study, design and results, I would like to make a few key points about Opioids and TD-1211.
As many of you know, Opioids are the one of the largest and most effective class of medicine used for managing various pain conditions. Opioids primarily exert their analgesic effect by acting on regions of the brain and spinal cord inside the central nervous system or CNS. However, Opioids also circulate outside the CNS compartment, which result in a wide range of side effect including constipation, nausea and pruritus.
For many patients on opioid therapy, Opioid Induced Constipation or OIC is a significant problem as they are currently no orally observed medicines approved in the US to help alleviate the side effects. TD-1211 was selected as our lead compound for development based on preclinical data that demonstrated excellent peripheral restriction. That is TD-1211 is a highly selected antagonist opioid receptor that is largely excluded from the CNS compartment.
We previously reported positive results from a Phase I single-ascending dose study in healthy volunteers. We said that our plan was to move TD-1211 into and through an efficient program that combined a Phase I multiple-ascending dose study in healthy volunteers and a Phase II dose escalation study in patients suffering from opioid induced constipation. We have completed this combined program on schedule and are now reporting the data here.
I remind you that the slide presentation can be accessed from our website and the slide number referenced during the discussion can be located at the lower left corner of each slide.
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