Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q4 2023 Earnings Call Transcript

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Operator: And our last question will come from the line of Divya Rao with TD Cowen.

Divya Rao: Hi, guys. This is Divya on for Mark. Thanks for taking my questions. I have two kind of follow-up questions. One on Eric’s question earlier, was the difference in the primary endpoint between mitapivat and Luspatercept for the transfusion-dependent patient, something that was recommended to you by regulatory authorities, or was it more of an internal choice? And then my second question is turning to the design of the Phase 2b and MDS. Do you plan to test multiple dose levels of AG-946? And any color on the enrollment criteria versus what [inaudible] will have in the command trial would be great. Thank you.

Sarah Gheuens: Awesome. Thank you. Thanks, Divya. So in regards to the first question, primary endpoint, yes, indeed we do, as I just mentioned on the previous question as well, we do our development in collaboration with regulators. So we take feedback from the regulators very seriously and try to really incorporate the feedback as best as we can. And so that’s how we ended up settling for the 50% end points in a rolling 12 week period interval, which we indeed truly believe is a more dynamic endpoint and really reflects the real world experience of a patient. So this is where it’s always very good. And we’re always very grateful to be able to have those conversations because I do think incorporating feedback from multiple stakeholders always leads to better design choices.

So that’s that on the primary endpoint. And then in regards to your question for MDS Phase 2b, yes, the Phase 2b is indeed multiple doses that we are testing. We are going to test higher doses than we originally anticipated, just because we have learned from our Phase 2a that MDS patients overall have lower exposure to same amounts of drug than other patient populations and healthy volunteers. So we are incorporating those learnings into our Phase 2b. And in regards to our inclusion criteria, we have not — we haven’t presented a trial in progress post or anything like that yet, but you can expect the population to be relatively similar to how our population was in the Phase 2a. However, we will be focusing on transfusion, patients with transfusion burden.

It will also be a broad MDS population, just like we allowed in the 2a. We’re not excluding per se a population like specific mutations, things like that.

Operator: I would down like to hand the conference back over to Mr. Brian Goff for closing remarks.

A – Brian Goff: All right. Thanks a lot, Norma. And thank you very much, everyone, for participating in today’s call. Very good questions, which we very much appreciate. As you heard today, our team has great conviction in our potential to deliver transformative new therapies to patients and significant long-term value to shareholders. And we really look forward to speaking with all of you again soon. So thanks a lot.

Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.

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