Steven Perrin: Oh, I thought you were going to take that one, DA. The thing that drives new onset diabetes in these polypharmacy applications is toxicity to the beta cells that are in the pancreas. And CNIs have particularly high toxicity to those beta cells that are in the pancreas that secrete insulin.
Pete Stavropoulos: Great. And is there anything else? I mean from my understanding, steroids may also affect the development of post-transplant diabetes?
Steven Perrin: That is correct. Steroids do as well.
Pete Stavropoulos: Okay. All right.
David-Alexandre Gros: And we have in €“ in our two trials €“ in the BESTOW trial, we will be across both attack arm as well as the tegoprubart arm. We’ll be looking to taper the patient’s off steroids completely.
Pete Stavropoulos: Okay. And what’s the timeframe of tapering off the patients, if you can disclose that?
David-Alexandre Gros: It’s pretty quick, it’s a few months.
Pete Stavropoulos: Okay. All right. Well, thank you for taking my questions and congratulations. And I look forward to seeing the data tomorrow.
David-Alexandre Gros: Thank you.
Steven Perrin: Thank you.
Operator: Our next question comes from Thomas Smith with SVB Leerink Securities. Please proceed.
Thomas Smith: Hey, guys. Good afternoon. Thanks for taking the questions and congrats on the early data here, and thanks for providing the latest available data points on those three patients. I was just wondering if you could just at a high level, put a little bit more context around those reported eGFR rates and how those compare to current standard of care at those time points?
Steven Perrin: Go ahead, DA. Sorry.
David-Alexandre Gros: eGFR rates are €“ have been shown their averages to be pretty stable in multiple longitudinal studies, typically in the 50s with standard of care. And that’s now demonstrated to be the case both with some large patient population studies that have had as many as 20,000 patients in them as well as with some historical clinical trials including those that were done with belatacept and iscalimab.
Thomas Smith: Okay. Got it. And then on safety, it sounds like you continue to have a pretty clean profile here. Haven’t seen any SAEs, which is good. Just in terms of the AEs that have been deemed drug-related, any additional color you can provide on these? Or do we just have to stay tuned for the presentations tomorrow?
David-Alexandre Gros: I think the one that we pointed out was we had a patient that had BK viremia that is not an uncommon occurrence after transplant. And of course, the patient was immunosuppressed using €“ at the time using triple therapy since they were on tegoprubart as well as mycophenolate and steroids. But overall, the safety and tolerability of tegoprubart continues to look good.
Thomas Smith: Okay. Great. And maybe just one last question and appreciate the color on the enrollment and the DSMB review with the first three patients. Maybe you could just talk about sort of your overall expectations in terms of pace of enrollment and whether you think there’s anything else that you would want to do at this point to maybe augment enrollment pace into the study?
David-Alexandre Gros: So we expect with our Phase Ib study to finish enrollment by the end of the year. Enrollment in transplant trials can be a little bit lumpy since there are some patients that might come in with planned transplants if they’re receiving a kidney from a living donor, but the majority of patients today receive a cadaveric donor. And so it becomes harder to plan for obvious reasons. The way one plans is by making sure that one has enough sites and as a result that enough cases are being done at the various hospitals. So today, we have five sites that we’re using in three different countries for the Phase Ib, and we expect that to be sufficient in order to be able to enroll our trial by year’s end. Of course, for the larger BESTOW study, we’re going to be using many multiples of that amount of trials in multiple countries, but primarily in the United States.
