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Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX)

LX4211 Positive Results in Type 1 Diabetes Clinical Trial Special Call

April 14, 2013 08:30 AM ET

Executives

Arthur Sands - CEO

Pablo Lapuerta - CMO

Jeff Wade - CFO

Brian Zambrowicz - CSO

Analyst

Thomas Wei

Stephen Willey

Liana Moussatos

Operator

Good morning, my name is Tierce and I will be your conference operator today. At this time I will like to welcome everyone to the Type 1 Diabetes Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks there will be a question-and-answer session. (Operator Instructions). Thank you. I would now turn the conference over to Dr. Arthur Sands, Chief Executive Officer.

Arthur Sands

Thank you and I would like to thank everyone for joining us this morning. Before we start I will be making certain forward-looking statements this morning and I refer you to our filings with the SEC regarding risk factors that affect our business.

As we are -- we’re excited to announce this morning our recent results, the most recent from the study of LX4211 and type 1 diabetes and we thought it was important to take a little time here, since it is an important milestone in the development of this drug to discuss the results with you. I am joined by Dr. Pablo Lapuerta; and Dr. Brian Zambrowicz, Pablo is our Chief Medical Officer as you know and Brian our Chief Scientific Officer as well as Jeff Wade our Chief Financial Officer. And I will go ahead and run through the slide decks fairly quickly with you all. And then we’ll have time for -- comments from my colleagues on line. And then also we’ll have a Q&A session.

So to provide some context for these results I would like to start with the slide entitled 2008's FDA guidance for the industry for type 1 diabetes clinical development. And you can see from this document we've extracted some of the key statements. But it clearly points out that all experimental treatments that are not insulin analogs should be studied as add-on to insulin therapy. So of course insulin will continue and is the main state of therapy form of type 1 diabetes which is characterized by a complete loss of beta cell function to an autoimmune process and cellulose produced insulin. As you know onset occurs -- can occur any time in life's large numbers occur in childhood but also there is adult onset type 1 diabetes affecting up to 3 million in the United States.

If the product has potential hypoglycemia then the study design needs to allow for insulin dose adjustment, a dose adjustment to protect the subjects, and of course this was a key concern as we designed our study since it represented the first study in which we co-administered LX4211 with insulin. And then as noted here in this case unblinded control trials maybe appropriate. We took an approach as you will see to do a pioneer cohort that was unblinded [indiscernible] patients, and then proceed, expand into the expansion cohort which is a placebo controlled blinded portion of the study and 30 patients turned out to be 33 patients. And it’s that portion the results from which we’re disclosing today.

In terms of meaningful outcomes what we’d be looking for, what the FDA is looking for and I think everyone is not only an ability to perhaps simplify or reduce the insulin regimes and insulin carries with it itself certain safety issues rather narrow therapeutic window. But also any agent should improve glycemic control and of course the gold standard for that is the reduction of hemoglobin A1c glycosylated hemoglobin, but there are many other parameters as well that can be measured. So this provides some of the targets for drug development, this is of course 4211, a small molecule. And so we are looking for both improvement in insulin regimen but then also improvement in glycemic control through the whole development program.

If we turn to this study then, LX4211 type 1 diabetes proof of concept introductory slide, I mentioned already the pioneer group of three subjects, we’ve shared some of that data already and now we’re discussing the expansion group on approximately 30 subjects and how we enrolled 33.

We admitted into the study both the two major forms of insulin treatment currently for type 1 diabetes which is the continuous insulin infusion or insulin pump patients. And then also the multiple dose injection patients.

So the pump patients of course are on continuous infusion which is controlled by the patient and regulated according to their needs and their frequent testing of blood sugar. Multiple dose injections, the majority of patients are actually treated in this manner in the United States and especially globally, and this consists generally of basal insulin injections which will generally be a longer acting -- long acting insulin either once or twice a day.

And then also multiple meal time insulin injections which we’ll refer to as bolus injections which are given by the -- self-administered by the patient prior to meals and anticipation of the carbohydrate load that they are about to have for each meal. So, it’s an intensive regime for patients and one that of course they must continue their entire life.

We carried the study out of seven sites in the United States with really excellent centers with lead investigators and the dose is 400 milligrams taken before breakfast once per day. The treatment period is 28 days of treatment. This is the same dose by the way that is under development in type 2 diabetes.

If we turn to the patient population, the key inclusion criteria, we are studying adults here, ages 18 to 55, a very appropriate place to start. We are currently thinking about ways to move upstream in the type of genesis of disease to younger ages. But for this study 18 to 55 years of age, the hemoglobin A1c baseline values for screening that will require were between 7% and 9%, so they were poorly controlled although not as high a range as one would typically study in type 1 diabetes where we go from 7% to 10.5% typically.

Here this is a range that’s out of control but it was one that we selected to try to enrich for population that maybe a little bit more compliant for this initial study. So, these are now terribly out of control patients being in 7% to 9% range.

Fasting plasma glucose needed to be below 270, body mass index less than 32, fasting C-peptide less than 0.7 milligrams per liter. This is an indicator of insulin secretion and basically at this level it means that they are virtually making no insulin and that they are confirmed type 1 diabetics by this measure and triglycerides below 1,000.

It’s probably worth just reviewing briefly the study outline of slide five. This was a study in which after the screening period, we did -- we conducted series of outpatient baseline measures from day minus seven to day minus one where patients were put on continuous glucose monitors during this period. They begin their diary logs and get their baseline insulin eases.

Then there is an inpatient portion that starts at day minus one where the patients were admitted to the unit for approximately 48 hours and we get another 24 hours or so of baseline measures.

And then on day one, we start LX4211 therapy randomization or placebo therapy of course with the three pioneer groups, three pioneer patients they were open label and with the expansion cohort it is a placebo-controlled group.

Then after a period of acclamation to the treatment which is short about 24 hours the patients go or discharge from the clinic and go on to the outpatient treatment period again with continuous glucose monitors onboard which is monitoring what glucose levels approximately every five minutes. However the patients are blinded to that information that is recorded by the device and then goes into the clinic later.

The patients are of course monitoring their own blood glucose as they would normally by finger sticks and they are instructed along with investigators to manage their blood glucose as they did during baseline period or as they would normally to target so that are healthy targets for them and so that is conducted over this [premium] (ph) period of approximately 28 days.

At the end of this study, they are readmitted to the clinic. The data is collected from all of the diaries and we withdraw the study drug and then the patient is re-acclimated to their insulin regime if need be as was before and then discharged with an end of study visit after another seven days.

The primary endpoint for this study on slide 6 was to -- in terms of efficacy was to assess the effect of LX4211 on the total amount of bolus insulin required since this is the most proximal effect of our drug which we know that through SLT1 and [ovation] (ph) we effect postprandial glucose use and we have seen in previous studies fairly significant reduction and endogenous insulin production associated with this. And of course we're very careful on establishing our safety profile in the first study in type 1 diabetes.

There are several secondary objectives that were key and important. The most important ones being measures of glycemic control including hemoglobin A1c and again multiple other measures that we'll be publishing as we go forward here at the scientific congress the details.

We also looked at based on total insulin news and then a number of other pharmacodynamic and pharmacokinetic parameters. The baseline characteristics on slide 7 for the patients enrolled, you can see that these groups, placebo P O and LX4211; LX tolerance were very well balanced. In general, you can see the relevant parameters, I won’t go through all these, but I think perhaps most important as you look down at that list, the mean hemoglobin A1c for each group was the same, 7.9 at baseline. And the other parameters were on line.

If we shift to the primary endpoints, we're very pleased to see the significant reduction in bolus insulin use. So this is again mealtime insulin use, a reduction of 32% on LX4211 compared to 6.4% on placebo. And this was highly statistically significant as indicated by the P value of peak of 0.007.

Turning to slide 9; this was quite an impressive result, the reduction in hemoglobin A1c of 0.55% for LX4211 as compared to the placebo group of 0.06%. This again, just as a reminder is in only -- after only four weeks of treatment. So this is a very rapid and we'll say substantial effect, and it achieves statistical significance of a robust P value of – a peak of 0.002. So these two parameters taken together are again simplification of reduction in insulin use combined with an apparent improvement in glycemic control by hemoglobin A1c measures.

If we turn to the next slide, the pie chart slide, looking at glycemic control as measured by continuous glucose monitors, it’s worth walking through this slide in some detail. It’s very informative. At the placebo group you can see baseline and treatment groups. In green are the time spent in the target euglycemic range where patients would like to be, blood glucose levels of 70 to 180. And red is hypoglycemic zones, blood glucose levels less than 70. And then in yellow there is a time in hyperglycemic range which is greater than 180. So the numbers presented around the pie chart are the percentage of time spent in these various glycemic ranges over the time of monitoring. These are -- so baseline is several days of monitoring, and you can see that they were about 55.9% at that time in euglycemic range for the placebo group. The LX group of baseline was 56.4. They are very similar.

And now turning to the treatment zone, you can see I think immediately for LX4211 treatment, the green zone increases substantially and significantly to 68.2% of the time spent in the optimal zone, a P value 0.003. And the time in hyperglycemia, in yellow there, has decreased from 35.7% to 25%, again statistically significant. So most importantly with these changes, we saw no increase in the hypoglycemic time that is 7.9% to 6.7%. This does contrast with the placebo group, if you look at the hyperglycemic zone. They went up from 35.6 to 40.2 and then the time of the euglycemic range was virtually unchanged. And with their trend up there was a slight decrease in their time in hypoglycemic range.

So with LX4211 treatment, we’ve achieved an important result here which is better glycemic control, less time in hyperglycemia without increasing hypoglycemia which is of course a dangerous zone to be in.

Just one additional piece of data on slide 11; we did see a decrease in body weight which was significant, 1.72 kilograms over the four weeks period. And with that I will summarize and then invite comments from my colleagues on any items that I may have covered adequately, and there may be different perspectives they would like to share. But LX4211, that is primary endpoint by lowering bolus insulin substantially, 32% while improving glycemic control lowering hemoglobin A1c by 0.55% in four weeks, less hyperglycemia, better time in euglycemic range, no increase in hypoglycemia, and less glycemic variability by multiple measures which we have collected and will be publishing on later. From a safety standpoint, LX4211 was very well tolerated and our Phase 3 planning is ongoing for type 1 diabetes.

So with that, I'd like Brian and Pablo to comment and then we can open up for questions. Any comments?

Pablo Lapuerta

We were very pleased with the results and [indiscernible] is the first time that an oral agent has been able to significantly reduce hemoglobin A1c and insulin in a randomized fashion in type 1 diabetes.

Arthur Sands

Thank you, Pablo. Why don’t we just move right to Q&A and we can take questions?

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) You first question comes from Cory [indiscernible].

Unidentified Analyst

Hi there, it’s actually Matt Lowe in for Cory today. Congratulations on the data. I’m just wondering how this data impacts your partnership prospects and where you are in that process right now, and if you are maybe still looking to keep type 1 diabetes distinct from type 2 in any potential agreement? Thank you.

Jeff Wade

Sure. We’re continuing our partnership discussions and we continue to feel that those are going well. This is obviously only to the positive from that perspective and we are and have consistently been saying that we are expected to play a bigger role in type 1 diabetes in that partnership or any other arrangement and so that continues to be the expectation.

Operator

Your next question comes from Alan Carr.

Unidentified Analyst

Hi, guys. This is actually Mark on for Alan. I was wondering if you guys could comment a little bit on timelines going forward, what if Phase 3 trial might look like assuming current status quo no partner in place, what would timelines looks like for Phase 3 trial and how would that come together?

Pablo Lapuerta

Yes, so we’ve already submitted a meeting request to the Food and Drug Administration for end-of-Phase 2 meeting for type 1 diabetes, so we hope to have that within the next two months or so. Depending on how that goes, we hope that we can initiate Phase 3 and type 1 diabetes by the end of this year.

The Phase 3 trials that we’re considering for type 1 diabetes without a primary endpoint of hemoglobin A1c reduction, and in that context, these results are very important. It’s difficult to know how these studies can work because patients automatically adjust their insulin and so it gives us a lot of confidence and encouragement that in this study despite adjusting insulin we still have hemoglobin A1c improvement. So we do believe that will be a good primary endpoint for us in a Phase 3 program in type 1 diabetes.

Unidentified Analyst

And how long do you guys think this Phase 3 trial would go for and would you need a second trial?

Pablo Lapuerta

We’re going to have to discuss that with the FDA. On one hand, we do feel that part of this profile has been very low rates of hyperglycemia, and we would benefit from a larger program by potentially being able to show significant reductions in symptomatic and severe hyperglycemia. Yet, these results are encouraging that they do merit discussion with the Food and Drug Administration over the pathway towards approval.

Operator

Thank you. Your next question comes from Thomas Wei.

Thomas Wei

Hi, thanks for taking my question. I wanted to just clarify on a few things about the data here so, on the hypoglycemia numbers it looks like it may actually just be noise here but the time in the hypoglycemic range was actually less in the placebo arm than in the treatment arm. If you looked at definitions of hypoglycemia was there a numerical difference in favor of the placebo arm in this study?

Brian Zambrowicz

Sure. I think the important thing is since the placebo arm is doing some insulin adjustment, and if you recall the pie chart graphs, they are definitely going up in time spent in hypoglycemic range. They’re basically losing some control, so it’s never surprising if you drop insulin, you will drop hypoglycemia, if you’re losing your glycemic control, so don’t be fooled, what’s important is with LX4211 without question if you look at the pie chart you’re decreasing time spent in hyperglycemia increasing time in the euglycemic range and you’re achieving that with no increase so that’s I think the distinction between those two arms.

Thomas Wei

And aside from you know when we look at the A1c numbers, the placebo arm had a slight reduction in A1c but when you look at the pie chart, they had actually what looks like a significant time in the euglycemic range, I guess I wanted to just understand that and also what the titration paradigm that was, or the treatment target goals that were provided to patients in this study.

Brian Zambrowicz

Maybe one quick comment on the first part is that I wouldn’t make much of a -- wouldn’t say much more than there’s not much change in A1c in the placebo arm right, (indiscernible) it’s really hard to say that’s more than just noise and unchanged.

Arthur Sands

But what I’d add Thomas is that first of all the ends are small, so I don’t think you can expect a perhaps an exact correlation between CGM ratings and then HbA1c, they are different aspects of glycemic control, but in general they should more or less go together which I think they do.

In terms of the -- second part of your question, the instructions for patients after getting out of the clinic after the first two days, they’re instructed to target glycemic control in that 70 to 180 range so they’re all given the same instructions which is a reasonable range for their glycemic control readings which they carry on as per their normal habits by finger sticks, before meals, after meals et cetera whatever their normal routine is.

So they make those judgment calls, course they adjust their insulin based on their diet as the meals in real time as well as their exercise and all the other lifestyle issues that they cope with. So they have a standard in both groups given the standard instructions and then we looked at the data at the end.

Thomas Wei

So it was basically -- there weren’t specific like targets fasting, (indiscernible) glucose levels that patients were asked to achieve with their insulin.

Arthur Sands

No, that’s incorrect. That’s -- that can introduce a certain safety issue so basically you want them to behave as they normally would and target their euglycemic range as they normally would and that’s instructions that they were given.

Thomas Wei

And so a translation from a phase 2 that’s phase 2 trial into phase 3, would the FDA ask you to run a study under a very different set of conditions where patients are being asked not to keep their insulin regimen and their glucose levels roughly the same that they would actually ask you to introduce the more aggressive treat to target paradigm per patient.

Pablo Lapuerta

No, I believe that the FDA would support current targets as delineated by the American diabetes association rather than to ask for some sort of new set of targets for our Phase 3 program. So we believe this paradigm that we evaluated in Phase 2 is applicable to Phase 3.

Thomas Wei

Okay and then do the outcomes look any different for those who are on insulin pumps versus those who are taking [indiscernible] bolus injection.

Pablo Lapuerta

We don’t have that subgroup analyzed yet, the results we’ve looked at so far, with the results, we've seen general consistency and robust results in these data.

Thomas Wei

Okay and then the last question is, just based on the data that you have from the pie charts as well as the A1c number what would you extrapolate the full blown A1c effect to look like if you ran a longer six months trial or even just 12 weeks to get to the point of the typical period for measuring A1C.

Brian Zambrowicz

Sure, I mean obviously it's -- the A1C effect is dependent on the half-life of red blood cells, so we know that it will be -- it should be greater than the effect we see at four weeks, I would emphasize that we haven’t done longer studies in type 1 diabetics but we would anticipate a greater effect, I would emphasize that at four weeks here the 0.5, 5% reduction we’re seeing is pretty much equivalent to the effect that was observed with [indiscernible] at basically 24 weeks in Phase 3, so this is a nice effect already here at four weeks.

Thomas Wei

Okay.

Arthur Sands

That was -- Brian was referring to a study in type 2 diabetes.

Operator

Thank you. Your next question comes from Stephen Willey.

Stephen Willey

Good morning and congrats on the data. Just wondering if you could maybe provide us a little bit more color around and I guess specifically around any increases in volume or frequency of urination that patients may have experienced during the course of the study.

Arthur Sands

So I think Stephan at this time since this is all very new, we’re just disclosing that we’re very pleased with the safety profile, but we’re not going to go into details on it but there was nothing of significant concern and it was very well tolerated.

Stephen Willey

And did you guys look at basal insulin reduction as well?

Arthur Sands

We did, and there really wasn’t much of a change in basal insulin reduction, which contrast was what has been seen with some of the SGLT2 selective compounds in similarly sized trials in type 1 diabetes. So I think that will be an evolving point of differentiation for our agent, where we’re seeing primarily this effect on bolus insulin use.

Stephen Willey

And I think that the pioneer cohort too there is an approximate 15% to 20% reduction just amongst the three patients in terms of basal, correct?

Arthur Sands

Yes, now keep in mind there was -- for that group there was a bit more aggressive protocol for safety that is there was a proactive reduction of basal insulin use to make sure we did not get hypoglycemia. So it was a more aggressive safety stance, and in this study it was for hands off go ahead and regulate yourselves as you normally would.

Stephen Willey

And is that the same kind of protocol that has been employed in the selective SGLT2 studies?

Arthur Sands

Yes, they all implemented a proactive reduction sort of preemptive reduction in insulin of some percentage, and then there were small studies, both of these studies were open label. So they weren’t placebo controlled. And they did see those decreases but they really saw no change, they reported essentially no change in bolus insulin use, and they were about four week to eight week studies.

Stephen Willey

And then I know you mentioned, you made a commentary around the partnering process, it’s something that we obviously get asked about quite a bit. And so I just want to maybe get some kind of understanding as to whether or not this data changes the pace of any conversations you may be having or you think this may be just provide us with a little bit of color around how this data may or may not change the dialog?

Arthur Sands

Jeff would you like to address that?

Jeff Wade

I think that the data, they basically demonstrate one of the elements of the profile that we had wanted to see personally and so I think that this is something that is to the positive and the partnership discussions and increases our options, but we’re continuing with discussions that we had ongoing here. And again we’re hopeful that we can get those are coming close to a conclusion at this point.

Operator

Thank you. Your next question comes from Liana Moussatos.

Liana Moussatos

At the end of Phase 2 meeting with the FDA do you anticipate finding out whether you can pursue type 1 separately from type 2?

Arthur Sands

Pablo would you like to comment on that?

Pablo Lapuerta

Yes, we believe that we’ll get some insight on that possibility as we discussed the overall safety requirements for these two indications. We do believe that LX4211 should be developed for a type 2 but the regulatory interactions could give us a good sense of the timing, it’s possible that we emphasize type 1 and that’s something that we want to understand.

Operator

Thank you. And your next question comes from Kevin Kedra.

Kevin Kedra

Just want to ask for when we might be able to see this data presented, would that be at ADA or some time later? And also can you give us any update on the current succession plans?

Arthur Sands

You want to address the publication plans Brian?

Brian Zambrowicz

Well it’s too late to submit an abstract to ADA but we'll attempt to present it at next available major diabetes conference.

Arthur Sands

Yes. And with regard to succession plans, all we can comment is that the search process is ongoing.

Operator

Thank you. Your next question comes from David Friedman.

David Friedman

Hi, thanks for taking the question. Just to be clear number one is, do you guys feel confident that you have enough data and enough long-term data to go into Phase 3 in either diabetes segment and then is there a plan to go into Phase 3 on your own in type 1 or type 2 given the sort of long partnership timelines that we have seen here?

Pablo Lapuerta

Yes, so in type 2 diabetes we feel we have all the data we need to advance in to a Phase 3 program. The Phase 2 dose ranging study was very supportive and was a proper study similar in scope to that of the SGLT2 inhibitors that have moved forth.

For a type 1, we believe that these data are sufficient to move forward into Phase 3. We don’t have broad-based ranging in type 1 diabetes. We feel the type 2 data and experience we've gained with our compound are very relevant and support our dose selection for type 1. The efficacy and safety we have seen support our dose selection for type 1 and also moving forward into type 1 diabetes, we are considering evaluating more than one dose there. So, given the nature of these results and what we learned about the compound from both indications, we feel in a good position to move forward in type 1 diabetes and also in type 2 diabetes into Phase 3.

David Friedman

And then with regards to what happens if a partner doesn’t get signed, do you go forward on your own?

Jeff Wade

So, again our expectation is that we will have a partner but obviously type 1 diabetes is in terms of the development program is a different scope of program than for type 2 diabetes and that is something that we feel like that we could do if we chose to do that.

Operator

(Operator Instructions) And we do have another question from Alex. Alex your line is open.

Unidentified Analyst

Hi guys. Congratulations, very nice data. Given that this addresses directly what the FDA is looking for in a type 1 drug and that there aren’t no oral therapies, do you think this might fit into a fast track status for type 1?

Pablo Lapuerta

Yes, we do. We feel that this is novel and medically important and we're interested in discussing our options with the FDA on this matter.

Operator

Thank you. Your next question comes from Kelly Clove.

Unidentified Analyst

I was wondering if you could talk a little bit about any research that you might have done with patients or teachers or parents, families any of the new one-two have a lot to think about in dosing insulin especially [indiscernible] during the day and a little more about what that might enable and if you could get something like this that's drug approved?

Arthur Sands

So, it’s first this is speculative, but I think some of the next steps would be to move this drug and trials, appropriate trials and in the younger age groups and we're studying that possibility right now stepwise probably first with teens and then teens and young adults and then done stepwise younger.

Of course those trials are intense and it’s a patient population that, especially the teens that are, can be notoriously poorly regulated, so we think it could offer some potentially significant advantages in terms of simplifying insulin regime depending on the insulin needs of the patients they could have. We have seen some fairly dramatic reductions in the need for bolus insulin section or the quantity of it and that could really have a lifestyle improvement during school time for example. So, we have to see how that all plays out, but I think there is a potentially significant benefit there in terms of the simplification of insulin regimen while of course also providing better glycemic control, good question, thank you.

Unidentified Analyst

Since it seems like being able to get rid of potentially insulin dosing at full could really be -- that could be major drive, getting rid of insulin dosing at full could be a really big deal and also seems like the update is a little more open, so looking at time-installment data and so forth and I was wondering if [indiscernible] impression as well.

Arthur Sands

Looking at which kind of data, Kelly, I didn’t hear that.

Unidentified Analyst

Time-installment or time and range data? Now that there are actually products that can measure that, hyperglycemia and so forth, there seems to be more [indiscernible] and more interest in it.

Arthur Sands

I think that this is definitely growing with the technology of the CGM. It's very powerful, obviously very quantitative in addition to your regular safety reports on hyperglycemia. So I do think that will be very important and again we would hope that some of the benefits of day time insulin use, that you’ve kind of alluded to would actually occur. Well, thank you.

Operator

And at this time there are no further questions.

Arthur Sands

All right, well, I would like to thank everyone for participating at this morning. Again, we're very pleased and excited by these results and we will keep you posted as we go forward. Thank you. Bye-bye.

Operator

Ladies and gentlemen, thank you for joining today’s conference. That does conclude the conference. You may now disconnect.

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