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» Neurocrine Biosciences' CEO Reviews Phase II Results of VMAT2 Inhibitor NBI-98854 for Treatment of Tardive Dyskinesia (Transcript)
So with that …Unidentified Analyst Great. Thanks for the overview. So maybe we can start with Elagolix and endometriosis. Kevin C. Gorman Sure. Unidentified Analyst The first Phase 3 you just started a few months back, can you walk us through the Phase 3 design and how that compares with your Phase 2 Daisy PETAL child? Kevin C. Gorman Sure. Just as a background, prior to partnering with Abbott we had treated well over a 1,000 women with Elagolix, about 700 of them for up to six months, continuous treatment with Elagolix. And what Elagolix does is it’s a GnRH antagonist, it’s a small molecule orally active and it does definitely lowers Estradiol levels in women. Estradiol is the main growth factor in – for endometrial tissue. Its in endometriosis, the endometrial tissue moves outside the uterus causes adhesions throughout the body, causes bleeding, causes pain by lowering Estradiol levels we found a range of Estradiol levels in which the pain of endometriosis, the main problem is ameliorated or completely eliminated. And yes, there is enough Estradiol circulating such if you still have good bone health. The Daisy PETAL study was our last Phase 2b study that we had done in the program. And that study was done in order to validate the primary end points have now gone into the Phase 3 program. And these were end points that we had validated in conjunction with the FDA, working very closely with them over several years. So, the design of the Phase 3 study is actually extremely similar to the design of that last Phase 2b study. In that the patients are treated six months continuously with Elagolix. The primary end point is actually taken at month three and the primary end points are two that both [toxicity] independently hit. One is Dysmenorrhea, which is pelvic pain during menstruation and the second is Non-menstrual Pelvic Pain. Both of those end points have to be hit independently. And then they can – and as I said that is at month three. So it’s comparing their baseline scores on Dysmenorrhea and Non-menstrual Pelvic Pain versus month three scores on both of those.
And then it stays blinded – double blinded placebo controlled through month six, where then you see persistence of the effect and looking at other secondary end points at that point in time such as analgesic use. What then the patients do at the end of month six, patients have the choice that every one placebo would be randomized now on to drug, those who are currently on drug can continue in the trial and get six additional months of open-label treatment such that we have one-year of continuous treatment for ICH guidelines or the patients can then stop taking drug and go into a follow-up, a drug free follow-up portion. Those patients that go on to the additional six months a continuous treatment after that six months, so a total of one-year of continuous treatment, then they go into a drug free follow-up period that could last up to one-year at that point of time.The point for that follow-up period is to obviously look at the recovery of Estradiol levels, which we know from the Phase 2 study in six months a continuous treatment that Estradiol levels come right back up menstruation if it is been perturbed comes back to normal within 30 days for over 90% of the women, and then also to look at bone health. So, over that one-year of continuous dosing, every three months, the women will be given DXA scans to look at their bone mineral density and then during the untreated portion they will get a bone scan then again at six months to see if there has been any bone loss and we would anticipate minimal bone loss nothing clinically significant, but to see that bone loss come back or utmost it might take 12 months of follow-up. Read the rest of this transcript for free on seekingalpha.com