Selecta Biosciences, Inc. (NASDAQ:SELB) Q4 2022 Earnings Call Transcript

Boobalan Pachaiyappan: All right. Great. A few questions from our end. So firstly, with respect to IgA Nephropathy, obviously, you might have — you are aware of FDA approval of Filspari, sparsentan. So I’m curious how this FDA approval might alter the dynamics of your IgAN program, especially in light of the fact that the agent that was approved may increase the risk of liver injury and birth defects.

Carsten Brunn: Yes. So maybe I’ll let Peter just talk a little bit about our approach here and why we think it’s a truly novel approach and really see this complementary to some of the other products in development, Peter?

Peter Traber: Yes, happy to answer that question. I think that what you’re referring to is that there were some warnings on the latest approval based on age group. We don’t anticipate age group issues, but of course, we will be starting our development program in adults. Now with regard to the specific approach, all the approaches that are — have either been approved or are in development are either looking at a type of steroid, which affects the upstream production of IgA or downstream effects of the deposits in the kidney. We’re the only approach, which is targeting the IgA immune complexes in the kidney to try to clear those to see whether that will improve the disease. So our approach is complementary to the two drugs that have been recently approved as well as all of those in the development pipeline.

Now approval of additional drugs will certainly affect the development program from the standpoint of exclusions and inclusions and standard of care and so forth. But we’ll have to wait to see how that evolves with the recent approvals. But by and large, ours is a novel approach that no one else at this point is utilizing.

Boobalan Pachaiyappan: As you’re thinking deeply about your IgAN program, just curious, are there specific biomarkers that you’ll be paying close attention maybe in the next few quarters to gain confidence in the program in addition to say ?

Peter Traber: Yes. So biomarkers, you’re talking about of effect in IgAN. Yes. Okay. Yes. So the biomarkers that have been looked at, of course, and are most important is urinary protein excretion. That’s number one. Number two is kind of the most important one is the effect on kidney function, which would be eGFR. But we’re also exploring a variety of urinary markers and other markers that we might be able to utilize. But the two most important are urinary protein for albumin excretion and eGFR, if I understood your question properly.

Boobalan Pachaiyappan: Got it. And then maybe a market opportunity question in IgAN. So roughly 30,000 to 50,000 patients. So is there a specific population that you’re planning to target with your agent or is it for general or all IgAN patients?

Peter Traber: Well, I think that we are looking at that carefully. We haven’t decided exactly which patient population or segment that we will focus our development program on. Obviously, there are different ways to segment the patients in terms of when they were diagnosed, whether they have failed other therapies, what their baseline renal function is, whether they have evidence of progressive — rapidly progressive disease or slowly progressive disease. We’ll be looking at all of that to take into account how to focus our program. And we haven’t really made those decisions yet, but we do think that patient segmentation will be an important part of the program.

Boobalan Pachaiyappan: Great. And maybe one final question with respect to your Astellas gene therapy collaboration. This is more a clarification. Is there a requirement that the agent or the gene therapy agent plus your Xork it should get to skeletal and cardiac muscles.