Genfit SA (NASDAQ:GNFT) Q2 2020 Earnings Conference Call - Final Transcript
Sep 30, 2020 • 04:30 pm ET
Thank you. We will now begin our question-and-answer session. [Operator Instructions] Our first question comes from Thomas Smith, SVB Leerink LLC. Please state your question.
Hey guys, thanks for taking the questions. I have a few. I guess let me start with the Phase III PBC trial. Can you give us a little color around the rationale for the elafibranor dose selection in the Phase III and I guess what went into the decision to move forward with only the 80 make dose level.
Yeah, sure, thanks Tom. Hey. Hi, how are you doing. So I have here with me din din of a all know or cents Officer and COO and I will let him but that question. Tom, thanks for the question and answer that question. I think we have to come back to the results of our Phase II trial. So remember 2 Phase 2 trial clearly show efficacy of elafibranor not only on the out on the primary endpoint which is alkaline phosphatase but also hitting positively with high significance on a composite endpoint, and that composite endpoint was the one that was used as a surrogate endpoint for registration of the current second-line therapy but also that the same endpoint which is being used in our pivotal Phase III trial.
Okay. So remember the Phase II was run at 2 doses, to your 0.80 and 120 and you saw as when we presented the data at EASL and in 2019 that it hits on those endpoints, but also hits on various different markers and there was data showing a potential where we see a trend on pruritus.
Okay. We're elafibranor had a trend to be beneficial and providers so at those 2 doses of 120. We consistently see equally potent activity across the different markers and across the different endpoints. Okay. There, there were some slight differences, but we think that those differences were related to slight different system baseline. But having said that clearly equal potency between the 2 doses and when you consider we decided to go with a single dose, which is the 80 milligram dose there is no other reason we as not realizing the way nuclear receptors work. I think what you want to do is find a dose we get activity and not go much beyond that to avoid any off target effects and so on. That's not to say that there will be signed the issues. We did not see any safety or tox issues consistent with all the other trials with elafibranor up to date. So because of the equal potency that we see between the 2 doses we decided to go with the 80.
Got it, okay. Thanks, Dean for that for the color. I guess also in looking on clintrials.GOV it looks like there is a requirement for paired liver biopsy listed as one of the inclusion criteria. Can you talk a little bit about this requirement was there something FDA explicitly 4 if so why