So with that …
Great. Thanks for the overview. So maybe we can start with Elagolix and endometriosis.
Kevin C. Gorman
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.