Unidentified Analyst: That’s helpful, thank you. And also just curious why there’s less interest from docs and patients for six months dosing than three months?
Andrew Komjathy: This is Andrew, a couple of comments there as we look through the data. First of all, there potentially could be some perception as happens with dosing intervals with other products that you might be able to — you might be losing some levels of efficacy as you extend the dose. We don’t intend that to happen. We understand that efficacy is an important element of treatment, so our intention is to develop of highly effective treatment for both a three and a six month dose. So we believe that that might be an issue. The second issue is that the patients that had the six month dosing option had obviously two injections. And what quite a few patients, especially with Taxiro experience is injection site pain associated with the citrate buffer.
We obviously, or we’re going to be developing a citrate free buffer and we expect to have that level of pain be significantly reduced. So the numbers are relatively small in terms of the difference. I think the good news for us is that both physicians and patients are very excited about both dosing options. But again, I think if we can demonstrate high efficacy at both doses and have a formulation that reduces injection site pain. I think that those differences could be addressed.
Unidentified Analyst: That’s helpful. Thank you. My last question is on the ADARx data that was presented at ACAAI. If you can speak about the read through from that data for your program. Thank you.
Jill Milne: Yes, so with regard to yes, ADARx had presented this weekend at ACAAI as well as we have, I think based on the data that we saw presented by ADARx, we do believe that we have a better chance of technical and regulatory success with STAR-0215 and that we are more advanced. I think what we learned over the weekend about their program is that from what we understood, they’re currently limited on which dose they can take forward based on safety concerns. And the 2 mg per kg dose that they are advancing 1st to patients does not appear that it’ll get them through every six month dosing. And so obviously lots more information to come from them.
Operator: Our next question comes from Hartaj Singh from Oppenheimer.
Hartaj Singh: Hey, great. Thank you for a couple of questions and then a really nice presentation. We had done a survey with 25 high prescribing physicians and a lot of, Andrew, what you’ve been saying was kind of we saw concordance in our survey, but I had just a couple of questions extending from that from the survey that we did. One was just what are you hearing from payers? There’s a very competitive area. There’s a lot of different options. The payer dynamic and the competitiveness is also, I imagine, a thing. So one, what are you hearing from payers or if you haven’t gone there yet what’s the work, you’re thinking of doing there, preparing? Secondly, there still seem to be somewhat of a lack of awareness. There was a core group of our 25 physicians that seemed to really know 215 very well and others that seemed to be sort of kind of aware of it.
How are you going to tackle that? And then lastly, for Chris, just on biomarkers, Chris, the biomarkers you’ve been showing us from preclinical in Phase 1, could those in any way help in the Phase 3 trial in coming up with the design that could be faster? Thank you for the questions.
Andrew Komjathy: Sure. So we did a payer landscape assessment earlier this year. And what we learned is that, at least right now, ultimately, patients can get the product that physicians will prescribe in HAE, but over the class is going to continue to be managed. So I think like in other rare diseases, there might be some work associated with getting patients onto the treatment that they want. But generally you can get there. But again, the class will continue to be managed more actively as more treatments become available. The other thing that we heard is that efficacy continues to be a very important element of what the payers are looking for. So again, given the profile that we’re looking to develop, we’re looking to develop a treatment that hopefully can provide comparable efficacy in terms of attack rate reduction.
There’s an opportunity for us to keep even more patients attack free, but then also combine that with a product that patients obviously would be more compliant with. So that’s what we’re learning from the payers in the US. I would say that from an awareness perspective, obviously we’re generating additional data that we’re going to continue to share at conferences. We are creating a [inaudible] function. We started that process earlier this year. We’re looking to grow that. So I think that our awareness amongst the top one KOLs is very high. I think our awareness within the HAE community continues to grow. But I do believe that we’ll continue to publish hopefully very impressive encouraging data that both physicians and patients will be interested in.
And as we continue to grow our organization, hopefully we can increase that share of voice within the community.
Christopher Morabito: And , Hartaj, regarding biomarkers, the biomarkers that we and others use in this phase are useful for target engagement, but don’t, I think, get up to the level of surrogacy. So I think we’ll be able to use PD to inform the potential dataset that we will bring to regulators, but not rely on it. As I mentioned before in other meetings that we’ve had, I think PK is meetings that we’ve had here in investor settings. The PK itself, I think, is a stronger supporter of potential effectiveness. We target 12 micrograms per mil as a threshold, we believe confers the potential for effectiveness. So we’ve been looking very closely at that. We will be looking obviously at PK and patients in our Phase 3 trial. So, PK and PD will support, but I don’t think replace the dataset we’ll be able to use for Phase 3.
Operator: So our next question comes from Farhana Sakloth from Ladenburg.
Farhana Sakloth: Hi, good morning. This is for Farhana on behalf of Michael. So first congrats on the quarter. As most of our questions have been asked, but we’ll just follow up on one. You guys said that the Phase 2, I mean, sorry, the phase 1b was enrolling faster because there was no placebo arm. For the Phase 3, if I heard correctly for the design, that is going to be a placebo arm. So do you see that there will be an impact on enrollment?
Christopher Morabito: I do think that there will be an impact on enrollment, but I think that we’ll be able to mitigate it with a variety of factors, including ideally strong proof-of-concept data that will continue to support the profile and raise awareness among sites. We don’t have intentions of making this a global trial as well, which will increase the opportunity for patients around the world to experience 215 and also to contribute to our dataset. And we’ve been working very closely with the community in not just talking about the profile, but also in the development of this medicine. And I think we all already have strong support from the community demonstrated by the enrollment that we’ve talked about with 215. And ideally that support will translate into support for Phase 3 and enrollment into the trial in Phase 3.
