Operator: Our next question comes from Kripa Devarakonda from Truist Securities.
Srikripa Devarakonda: I have a question on TEPEZZA in TED. Can you please talk about where you are with this subcu program? I think the Phase III is ongoing. Just a little bit of update on that. And as you continue to treat more patients with TED, what are you hearing about concerns around safety concerns? And is that having any impact on uptake?
Robert Bradway: We’ll take it in 2 parts. Jay, you can address the clinical questions. And then to the extent that, Vikram, you want to share any thoughts on the marketplace, jump in.
James Bradner: Yes, thanks for the question. The development of a subcutaneous administration of TEPEZZA is a major priority for Amgen R&D in the program. We have initiated a Phase III study. This will be — this is in moderate to severe active TED. And the design is akin to what we have reported already with the intravenous label-enabling studies completed to date. And Vikram, if you want to speak to the clinical experience.
Vikram Karnani: Yes, I think — so thanks for the question. I think the question was around AEs and if that is limiting growth. And I imagine, Kripa, that you’re maybe specifically referring to hearing loss or about hearing loss. So let’s start at the top. TEPEZZA, it very effectively treats TED, which we all now is a pretty severe and debilitating disease. IGF-1, we know is going to be involved in hearing function. So during the clinical assessment and the clinical development of TEPEZZA, we very carefully have — we looked at — we assessed hearing function. We now have included this in the warnings and precautions section of the PI, along with a recommendation for assessment and monitoring. It’s important because patients who use TEPEZZA should be monitored for any specific experience with hearing impairment.
We’re also working with professional societies to increase education. And while many physicians do use a baseline hearing assessment, getting it in the label helps standardize this approach, okay? So after working through the management of this with HCPs, this has not generally turned to be a barrier for growth as physicians generally understand the favorable risk-benefit profile of TEPEZZA.
Robert Bradway: Thank you. So Julianne, we’re pushing up to the appointed bottom of the hour here, but we still have a few questions in the queue. So we’ll take a couple more to try to get through your questions. If we don’t get to everybody, obviously, Justin and his team will be around this evening to answer any questions. But let’s try and click through these, the ones we can quickly, Julianne.
Operator: Our next question comes from Michael Schmidt from Guggenheim Partners.
Michael Schmidt: I had one on BLINCYTO, which has recently gained some commercial momentum recently. And there was some interesting academic data reported last week in Nature Medicine showing some activity in RA. And so I was just wondering if you have any plans? Or how are you thinking about potentially developing BLINCYTO or maybe other BiTEs in autoimmune?
Robert Bradway: Sorry. In autoimmune disorders?
Michael Schmidt: Yes.
James Bradner: Thanks for your question. With very deep expertise here in CD19-directed therapeutics, with deep and committed expertise in inflammation and autoimmunity, we’ve been following this space very closely, the early suggestive evidence from CAR T-cell therapy and, more recently, this work that’s been reported in systemic sclerosis. And as you noted, 6 patients with quite refractory rheumatoid arthritis is very exciting to see. And so you can imagine that we’re well organized around this opportunity. And we found that work quite inspiring and we’ll have more to report in the future.
Justin Claeys: Julianne, I think we’ve got time for one more question.
Operator: Our last question will come from Gary Nachman from Raymond James.
Gary Nachman: Great. So back to MariTide, I have to finish with that. As you’re planning for the Phase III studies, do you have a sense of when you could start those? How big those might be? And anything about design and overall timing relative to other Phase III studies in this space? And any strategies you have to accelerate those studies as quickly as possible and how you’ll incorporate both U.S. and ex U.S. in the program?
Robert Bradway: So Gary, again, we appreciate it. I can understand why you’d be asking those questions. As I said in my remarks, we will do our level best now to successfully complete the Phase II study and then work swiftly with regulators to agree the program that establishes safety and efficacy in Phase III, and we’ll do that as swiftly as we can. We recognize there’s a huge unmet need still in the marketplace, and we believe we have an asset that can help address that. But Jay, I don’t know whether you feel you can say anything more specific, but jump in if you do.
James Bradner: Yes, I’d say the same, Bob. Gary, as you know, this is one part, collecting the data that regulators rightly expect, and ongoing conversations around the design. This study is moving as rapidly as possible within — this program is moving as rapidly as possible within the organization, you can rest assured.
Robert Bradway: Okay. Well, again, let me thank you all for joining the call and reiterate that Justin and his team will be around if you have any further questions. We look forward to having an opportunity to talk to you in the summer after the second quarter and provide update on the flow of information that we expect to generate between now and then on the many programs that we’ve referred to on the call. So thank you for your interest. Appreciate it.
Operator: This concludes our 2024 Q1 earnings call. You may now disconnect.
