The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: So for those who may not be familiar with Disc, can you provide a brief introduction?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: And you presented Phase 2 open-label data from BEACON at ASH. Can you just remind us what you saw?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: And you reported data from AURORA early this year. What did you see? And then can you just talk about your thoughts on what drove the outsized
placebo response and cumulative time in light without pain?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: And just to clarify what you just said, so then is the thinking that that change would be on the timing? Or are you considering perhaps some of the
other endpoints as well or a combination? Like how are you thinking about that?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: I was just about to ask you if you had your end of Phase 2 meeting yet. And I guess do you have a sense it sounds like not yet, but do you have a
sense for how amenable FDA will be to evaluating different registrational endpoints given that precedented endpoint?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: [Synosis] label was updated, I believe, last month to include warnings of serious hypersensitive reactions, including anaphylaxis that were reported
in the post market. Does this change the way you're thinking about Bitopertin's positioning or market opportunity?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: Now, Bitopertin is also being evaluated for Diamond-Blackfan Anemia. Can you just talk about this program and remind us of when we might see
data from the study?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: Great. Let's shift to DISC-0974 for non-dialysis dependent chronic kidney disease and anemia of myelofibrosis. Can you just talk about hepcidin
suppression and how DISC-0974 enhances iron availability?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: And for anemia of MF, can you just remind us of the data that you've generated?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: Great. And for CKD anemia, can you talk about the data that you've generated? And what should we expect to see with the updated Phase 1b data?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: And given how challenging it is to develop drugs for CKD, how is DISC-0974 differentiated? And what gives you confidence that can succeed in
this indication?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: Now, I know it's still relatively early, but what kind of feedback have you heard on your DISC-9074 from physicians or patients?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: Great. Let's just shift to DISC-3405. Can you just talk about hepatocyte and induction and the data you've generated on the impact to serum iron
levels?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: And what should we expect to see from the multiple-ascending dose data later this year, I don't know till the extent you can talk about it, like how
many patients might we expect of data and that kind of thing?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: Okay. And then are there any gating factors or decision points in pursuing some of the other indications that you've suggested as potential proof
of concept candidates?
Question: Jeff Hung - Morgan Stanley & Co LLC. - Analyst
: Great. We'll leave it there. Thanks so much for your time.
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