Infomedica’s Post

Transcript

Yes. So thanks for Vivid. One was a phase three clinical trial which was a treat through design with an active comparative placebo and the secondary outcomes were to compare muralism adversaries to Kinomap in this study And the trial was designed with two endpoints in mind, one was steamship noninferiority of miracles. Matters to kidnap at week 52 of CDI clinical remission and then the second endpoint was to look at endoscopic response. In addition there are a number of pre specified secondary endpoints but very much the top line results were that Mirantis AMAB was non inferior to us to Kanab. At week 52 CDI remission the event rates were 54% in the Marisma bomb 49% and it was taking AMAB and that was highly significant for non inferiority. For endoscopic response the two drugs essentially look the same. There was very little difference between them, both highly effective treatments and then for the series of pre specified secondary endpoints there were similarities. There was a combined endpoint of clinical remission and endoscopic response at week 52 and Miriam was statistically significantly superior to us to Kanab for that end point in addition. For all of those endpoints, we looked at pre specified patients with and without prior biologic failure and whilst there were no significant statistically significant differences, there was a consistent trend that Mirandize Amab was was superior to us to Kanab in the prior biologic failures. Yeah. So I think that's really important question to address. So SEQUENCE was a, a head-to-head clinical trial of risankizumab versus taking AMAB in patients who have failed one or more entity and F and those results have been previously presented and they showed superiority of risankizumab over us to Kanab for their primary and all secondary endpoints that statistically so and VIVID was a registrational trial which contained Murchison adversity, placebo, but also this active comparator against. You can map now. SEQUENCE was an open, labeled, unblinded trial, so both the patients and investigators knew what drug their patient was taking. However, the endoscopy assessment was blinded, so that adds rigour in an open label design. One of the important things with open label designs like sequences that some of the more subjective endpoints like clinical endpoints and may be higher than you expect just because there's an expectation bias. People know they're getting drugs that work and that they're generally can report that they're feeling better and so that's one of the the the key design differences. The VIVID trial was double-blind and double dummy, so very rigorous nobody knew what they were receiving throughout Think if you look at the effectiveness of mirandizing madness to Kanab in these treat through designs, excepting the nuances and the differences, actually the efficacy rates for clinical remission and scopic remission for two drugs look very similar. They're between 55 and 60% at one year clinical remission and around 30% endoscopic remission. So accepting the indirect comparisons numerically the two. 123 look quite similar. The key difference was that was the kinomap performed much better in vivid one than it did in sequence. And by that I mean that the endoscopic remission and response rates in Vivid one were actually almost double. They were in sequence and we could only speculate why why those differences were there. And there's many possible reasons such as like differences in inclusion criteria, differences in concomitant medication differences than the attrition rates between the trials and but those are the key differences and I think it's important. That people look into the nuances of the differences before making interpretations of one drug is better than the other.