Steve Freed: We’re here at the American Diabetes Association’s 78th Scientific meeting, and we have a very special guest with us who’s going to give us all the scoop and all the new things that are happening from the studies from Novo Nordisk. So I’d like to say maybe you can just give us a little bit of what you do, what your responsibilities are.
Todd Hobbs: I’m with Novo Nordisk and I’m currently the chief medical officer in the U.S., and I really serve as the medical voice on a lot of issues. But many times they’re data related, as we are here at this ADA session, and this year as I think you’re aware we’ve got a lot of data across many areas. Thirty-nine total abstracts and although no big CBOT reveal this year we do have a lot of exciting, I think from our perspective, and hopefully interesting data from an attendee and clinician and even patient perspective. So a lot going on.
Steve Freed: So let’s just jump right into this with the Pioneer One study. Can you tell us about the results of the Pioneer One and different approaches used in the analysis.
Todd Hobbs: Sure, so let me handle the first part of that and then we’ll dive into the analysis after that. The Pioneer One is the first of our Pioneer 3A program to report out for oral semaglutide. And there’s 10 different trials and they’re numbered in fact in order based on essentially where a type 2 diabetes patient would be in their journey with type 2 diabetes. So Pioneer One for instance is very early in therapy, those who are really going on OADs for the first time. And we’re looking at all three of the doses of oral semaglutide versus placebo. So there’s four different arms, the three doses that we’ve chosen that we’re investigating and are in our Pioneer program are 3, 7 and 14 MG; certainly once we apply for our indication with the FDA we’ll see how they view these doses but those are our intended maintenance doses and the data was very strong as you could imagine against placebo; those three doses were statistically significant and better in regards to A1C lowering, and also in regards to weight reduction Semaglutide, we know from Ozempic, which is currently approved in a weekly injectable has a very strong effect on glycemia but also positive effect on an individual’s weight. And so we’ve seen that as well in the oral. formulation.
Steve Freed: What does it mean for people with type 1? We know it works well [in type 2]
Todd Hobbs: Well at this at this point either injectable semaglutide, which is approved, or oral semaglutide, we’re not studying in type 1 at this time; certainly down the line that may be something we would consider but right now it’s focused on type 2 patients only. So we did study Victoza in the past in type 1 patients, and we know clinicians currently may try to use that off label; we’re not pursuing an indication either for Victoza or at the current time for semaglutide in type 1 patients.
Steve Freed: Having an oral GLP-1 is exciting, there’s been so much written about it. Where is that product right now, as far as coming to the FDA for approval?
Todd Hobbs: So we have 10 trials and the last one that will complete this year is Pioneer 6, and we expect that result by the end of the year, very close to the end of the year. So then we’ll put the data together, get the file ready and we’ve anticipated filing in 2019; as you would imagine probably not early 2019 because it’s going to take some time to get that together, and we’ll file that in 2019 and then as you know with the FDA it could be a short process sometimes but usually a more lengthy 10 to 12 month process, and we’ll have to see once we get to that. Next year at ADA I can probably give you more information on where we are with that.
Steve Freed: So you’re working on an oral product. Are you working on the next SGLT-2 with a GLP-1 combination?
Todd Hobbs: Currently we don’t have any assets in our portfolio that are SGLT-2 pills so we’re not looking at that combination now. We are studying them and used together, separately; in different of the Pioneer trials there are patients who may be on SGLT-2s and have the GLP-1 added, but we don’t own an SGLT-2 and aren’t looking to combine that with our oral semaglutide. The process to get oral delivery of a protein or peptide is not that easy, as you can imagine. And we’ve been working on this for decades so trying to combine that with another individual agent would be another challenge, and we certainly have not yet looked at that.
Steve Freed: Let’s switch our topic to SUSTAIN-7. What was the objective of the post hoc exploratory analysis of that?
Todd Hobbs: The main objective was to confirm that no matter where an individual type 2 patient would start on BMI, that there was a greater weight reduction seen with Olempic versus Trulicity versus the other weekly, and so we looked at different cuts or different breakdowns of BMI and throughout all those breakdowns there was really almost a 2 to 1 difference in weight reduction seen for Ozempic versus Trulicity. In fact at the higher BMIs is where we continue to see the greatest weight reduction, so patients who needed that the most are the ones that that really appeared to benefit in the data.
Steve Freed: And what are the implications of these results?
Todd Hobbs: Implications are that right now we know, and don’t want to go too long on this, but patients are really not getting GLP-1 agents as they likely should. They are still maybe six to nine percent of all new prescriptions for diabetes agents. We know from the clinicians we talked to, from the data, from the experts they really feel like that they should be moved earlier in the in the process and more patients should have them. So the weekly versions both of Trulicity and Ozempic have really become sort of the go to GLP-1 these days with starting patients on an injectable agent.
And so we hope that with the weight data and the strong data that we see through the SUSTAIN trial even through the entire results, this will continue to encourage more HCPs including primary care and more patients to try a GLP-1 in the form of Ozempic.
Steve Freed: So now let’s jump to Dual 9, what were the results presented here?
Todd Hobbs: Dual 9, I’m sorry I might have to go back to my notes on that one, but Dual 9 is one of iDegLira programs and it was looking at iDegLira versus Glargine. So it did show that there was a superior reduction in A1C versus continuing to titrate a basal insulin, and as we’ve seen throughout the Dual program with iDegLira there was a neutral effect on weight. So you can actually improve your glycemic control, you can get to better control, and in fact many times you had weight reduction but in this in this case those patients did not have an increase, whereas the patients on insulin saw around a 2 kilogram increase in weight. So that’s certainly a benefit.
Steve Freed: So what were the implications of the Dual 9 study for people with diabetes?
Todd Hobbs: So if you’re going to an injectable agent I think it indicates that instead of maybe having to choose a GLP-1 or an insulin you can receive benefits of both, meaning that you can have improved glycemic control, improved fasting control in particular, but also you get the meal control with the GLP-1 agent. And as we’ve seen again throughout the whole program and with our labeling and with our data from the indication or from the approval is that you can do that without a negative effect on your weight, which is generally what individuals see when they titrate insulin in any way they see that effect on weight. So yeah the data has been strong throughout all the Dual program.
Steve Freed: Let’s go to the Confirm study, what are the high level results of that?
Todd Hobbs: So the Confirm study is really, I would say an exciting interesting study because it’s real world in nature, and we know that this past year our randomized clinical trial, DEVOTE, which was a blinded study against Glargine U-100, showed very positive results that are now on the label in regards to reducing the risk of severe hypoglycemia versus Glargine. But this is the real world and we often get questions from clinicians, payers, even patients. How does this work in the real world and how is it gonna work for me or how is it going to work in our clinic? So this is over 4,000 patients that were studied in a retrospective fashion, but in looking at a real world fashion comparing versus actually U-300 or Toujeo versus Tresiba. And it did show that those individuals who came in that needed insulin intensification that went on either U-300 Toujeo or U-100 Tresiba, that they could do so and have less risk of hypoglycemia with U-100 Tresiba while actually achieving a difference in A1c, a lower A1c or a greater reduction I A1c. And this was done throughout several different data sets that EHRs capture in the U.S. and again in over a year’s time.
Steve Freed: The results are encouraging, to get the patient to stay on treatment?
Todd Hobbs: Yes. So we did see an improvement in adherence too, and we’ve heard that and but it’s always nice to try to investigate data that if we can really get patients to goal but then hopefully they’ll stay on their therapy, and we hear that some of the features of Tresiba, with being able to dose any time of the day, are making that easier for patients to really maintain on therapy, which we know is a key that we stop taking your therapy no matter what it is, then you’re kind of back to the drawing board and have to start again. So we’re encouraged by the adherence and the positive response.
Steve Freed: What is the importance of the real world data; what does it mean for people with type 2 diabetes?
Todd Hobbs: It’s important now but even becoming more important as we’ve seen from this conference. We’ve all for many years generated the RCT data, the randomized controlled trial data, for approval, for the FDA for regulatory reasons, but then you get out in the real world and large health systems, clinicians and even patients and importantly payers, say how does this drug or how does this medication work in our population. We have maybe different demographics or certain population and we need to know how this looks when it’s used in our group. So the real world data in the form of Confirm, and also we’ll begin to generate that real world data for Ozempic which was recently approved, is very important in all those groups. And again I think will increase in importance as we move forward in the coming years.
Steve Freed: So if you can talk about what’s in the pipeline that you’re really excited about.
Todd Hobbs: Well aside from oral semaglutide which I think has captured our excitement, that is the near-term pipeline that we really feel is going to be an advancement, and again because that GLP-1 use is not where it should be. And as an oral form, if we can get individuals who maybe fear the injection or don’t want to try an injection, they can have an oral form of semaglutide. We’re very excited about that. And in obesity we just kicked off our semaglutide obesity program, which is a standalone step program looking at four trials that will investigate semaglutide at a higher dose for specifically an indication in obesity, much like we did with liraglutide and Saxenda in the past for that approval. So that’s very exciting. We have a full type 1 research unit out in Seattle that continues to work on the inflammatory response of type 1. We have a fully pluripotent stem cell line that we’ve developed with UC Davis that we’re excited about for other diseases even outside of diabetes. So those things are some time to come. But we’re maintaining our efforts both in diabetes but also obesity as well.
Steve Freed: You know when I first started out in the field of diabetes I heard Novo Nordisk’s CEO talk, which just blew me away because he said,”Our goal is to put ourselves out business.” How are you doing with putting yourselves out of business?
Todd Hobbs: Well I’ll tell you that we’re working on it but type 2 diabetes is doing a darn good job of keeping themselves in business. We know not to joke about that. Type 2 diabetes with obesity as the leading contributor there is continuing just to rise in rates.