Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS)
Company Update Call
April 28, 2016, 08:00 AM ET
Julie Wood - Senior Vice President, Corporate Communications & Investor Relations
Gregory T. Went - Chief Executive Officer
Rajiv Patni - Chief Medical Officer
Jason Butler - JMP Securities
Vamil Divan - Credit Suisse
Irina Koffler - Mizuho
Serge Belanger - Needham & Company
David Amsellem - Piper Jaffray
Tim Lugo - William Blair
Ken Cacciatore - Cowen and Company
Good morning ladies and gentlemen and welcome to the Adamas Pharmaceutical Company Update Call. At this time all participants are in a listen only mode, later we will conduct a question-and-answer session and instructions will follow at that time [Operator Instructions]
I would now like to turn it over to the company, please go ahead.
Thank you Katherine, good morning. I'm Julie Wood Senior Vice President of Investor Relations and Corporate Communications at Adamas Pharmaceuticals. Thank you joining us for the specially scheduled call. Dr. Greg Went our CEO will lead the call. He will be joined by Dr. Rajiv Patni Adamas's Chief Medical Officer. Greg will begin with brief introductory remarks and then Rajiv will provide a clinical perspective on the announcement we made earlier today. Next, we will open the call for questions and then finish with closing remarks from Greg.
Please note that we will be making forward-looking statements during this teleconference that could include clinical, regulatory or commercial comment. Statements that are not historical facts including statements regarding the submission of a New Drug Application in 2016 and assuming FDA approval launching the product in 2017 are forward-looking.
Forward-looking statements are inherently subject to risk and uncertainties. For a discussion of some of the risks and uncertainties that could cause actual results to differ from those expressed in forward looking statements, see Adamas' annual report on form 10-K filed with the Securities and Exchange Commission on February 23rd 2016.
I will now turn the call over to Greg.
Gregory T. Went
Thanks Julie and good morning everyone. Earlier today, Adamas issued a press release announcing top-line results from the EASE LID 3 study, our third randomized clinical trial of the investigational medicine ADS-5102 for the treatment of Levodopa-induced Dyskinesia or LID associated with Parkinson's disease. As a reminder, ADS-5102 is our proprietary wholly owned extended release formulation of amantadine hydrochloride designed to be given once-daily at bedtime in order to achieve a high concentration amantadine from the early morning hours and then throughout the day.
We are thrilled to report that the study met its primary end-point of a statistically significant reduction in LID at week 12 in patients who received ADS-5102 versus placebo as assessed by the Unified Dyskinesia Rating Scale or UDRS. The P-value in this study was less than 0.0001. Additionally, the trial also met two key secondary endpoints including a statistically significant reduction in OFF.
These results are in line with data reported from our earlier randomized LID trials, which also demonstrates statistically significant improvement in LID for patients receiving 340 milligrams of ADS-5102 once nightly versus placebo at eight-weeks and again at 12-weeks and 24-weeks. Importantly, the types of adverse events associated with ADS-5102 were consistent with the known safety profile of amantadine, as well as the safety results from our earlier placebo controlled studies.
Before turning the call over to Rajiv for additional insights into the EASE LID 3 results, I would like to comment briefly about Levodopa-induced Dyskinesia a mysterious unmet medical need that represents for the estimated 150,000 patients living with it in the U.S. Currently there is no approved drug therapy for LID in the U.S. or Europe. In April of 2015, Adamas received orphan designation for ADS-5102 for the treatment of LID. Orphan drug status confers seven-years of market exclusivity on the first approved product with this designation.
As many of you know, ADS-5102 was designed to improved upon the pharmacokinetic profile immediately amantadine with the aim of enhancing efficacy without compromising its known tolerability profile. In PK studies ADS-5102 has been shown to achieve a high amantadine plasma concentration early in the morning when patient awake and waken that are sustained throughout the afternoon and would lower in the evening.
Based in part on this third set of positive results, we intend to submit a New Drug Application in 2016, we receive a favorable review, we believe we could have an approved medicine as early as 2017 to bring to these patients in need. We're absolutely delighted here at Adamas with this outcome. We would like to thank the people with Parkinson's disease, their caregivers, their physicians both in the U.S. and in Europe who participated in this EASE LID 3 study.
It is through the important contribution of clinical trial participants that medical progress is made and we're indebted. Additionally I would like to recognize the passion, the excellence, commitment of the entire Adamas team and the clinical regulatory and manufacturing teams who have conducted the ADS-5102 program. I look forward to moving them on to their next challenge.
I would like to turn the call over to Rajiv now who'll review the study plan and results for ADS-5102. Rajiv.
Thanks Greg, this is an important day at Adamas and it is a pleasure to share our excitement with you. I too want to express my gratitude to the Parkinson's community and Adamas employees who made this possible. This single agent Phase III study evaluated l-dopa treated Parkinson's disease patients with Dyskinesia and OFF time. The 13-week multi-center, randomized, double-blind, placebo-controlled study, which enrolled 77 patients from the U.S. and four countries in the EU, assess the efficacy of a 340 milligram dose of ADS-5102 administered once-daily at that time.
The study's primary efficacy analysis measured the reduction in LID over 12-weeks as assessed by the Unified Dyskinesia Rating Scale or UDysRS. The key secondary efficacy outcome measures were increase in on time without troublesome Dyskinesia and a decrease in OFF time. Additional secondary efficacy outcome measures included overall Parkinson's disease clinical status as assessed by the MDS unified Parkinson's disease rating scale or MDS-UPDRS and the clinician global impression of change. The treatment groups were similar with respect to baseline demographics and Parkinson's disease related medical history.
Efficacy analyses were based on a modified intent-to-treat population of 75 moderate to advance Parkinson's disease patients with LID. This MITT population included all subjects, who are randomized and receive at least one dose of study drug and had one post baseline primary efficacy assessments. This population was pre-specified as the primary analysis population. In this study the MITT only excluded two randomize patients, one from the placebo group and one from the ADS-5102 group. All 77 patients contributed safety data.
EASE LID 3 trial meet its primary end-point with ADS-5102 treated patient achieving a highly success statistically significant reduction in levodopa-induced Dyskinesia at 12-weeks with a P value less than 0.0001. The percent reduction from the observed mean UDysRS total score at baseline compared to that at week 12 was 50% in the ADS-5102 group compared to 18% in the placebo group.
Furthermore, statistical significant was demonstrated for key secondary analyses that were conducted based on patients reported dairies. These included on-time without levodopa-induced Dyskinesia and OFF time. ADS-5102 significantly increased on-time without troubles on Dyskinesia also referred to its good on-time by four hours per day as compare to 2.1 hours per day in the placebo group. In addition, OFF time was reduced by 0.5 hours per day in the ADS-5102 group and increase by 0.6 hours per day in the placebo group. The P values for these treatment differences where P equal to 0.0168 and P equal to 0.199 respectively.
The types of adverse events reported following treatments of ADS-5102 were consistent with the known safety profile of amantadine as well as safety results from the earlier placebo controlled randomized trials. The most common adverse events, those which occurred in more than two patients receiving ADS-5102 included dry mouth, nausea, decreased appetite, insomnia, orthostatic hypotension, constipation and visual hallucinations.
Visual hallucinations were reported by three patients in the ADS-5102 group and by two in the placebo group. Two patients in the ADS-5102 group experience visual hallucinations discontinued study treatment. In total, 10 patients discontinued study treatment due to adverse events, three in the placebo group and seven in the ADS-5102 group. Four patients all in the ADS-5102 group experience serious adverse events, which were considered related to study drug in one patient.
As we intend to submit these data for presentation at an upcoming scientific meeting, we are not providing further details of the study results at this time, but look forward to discussion the complete data set with you following this presentation. These results compliment a growing body of evidence, reporting to potential application of ADS-5102 in the treatment of Parkinson's patient.
Not only are we seeing a clinical relevant and statistically significant reduction in levodopa-induced Dyskinesia, we have also not seen notable statically significant decreases in OFF time. We believe ADS-5102 may have an important role in helping people with Parkinson's disease and we look forward to presenting our data to the FDA as we prepare our new drug application.
Now, I would like to return the call back over to Greg.
Gregory T. Went
Thanks Rajiv very much. ADS-5102, our first wholly owned product that we intended to bring to the market if approved by the FDA could provide a meaningful option for these Parkinson's patients in need of treatment. We think ADS-5102 is an important medicine, we think it has demonstrated a positive, safety and efficacy profile now in three randomized clinical studies.
So to summarize our commitment here is to establish Adamas as an emerging CNS company leader, one that can bring important new medicines to the markets, we believe we have now the plans in place to providing multiple approaches for growing the company including the launch of this product and the continued development of products in our pipeline.
Operator, we can now open the call for questions.
Thank you [Operator Instructions] And our first question is from Jason Butler with JMP Securities. Your line is open.
Hi thanks for taking the questions and congrats on the data. First question, are you able to give us any more color on the SAE what was considered drug related?
Jason thank you very much for your comments and questions. No, we don’t have any more detail for that at this time, we will have that when we get our poster presentation pulled together.
Okay great. And then on the just the patient diaries obviously clearly hits that stage on-time without troublesome Dyskinesia. It looks like the placebo site was a little larger in this study than in the prior Phase III. Was there anything about the patient population of a trial conduct or any color you can give as to why the placebo rate might have crept?
It's a different study in a different population, it's same inclusion criteria, same exclusion criteria, same set up Jason and it's I think it's too early in our analysis to assess beyond that. But it's not particularly concerning, it's a second study and that's why you do multiple studies in a Phase III program.
Great helpful and then just last question from me. When you think forward to the data where - that coming up in MSK can you just speak to how the prior experience with amantadine both as in IR and with 5102 including this datasets gives you read through to what we could expect from that trial?
Gregory T. Went
I wouldn’t Jason thank you for the question. I wouldn’t overdue the read through, as you know we've develop a fairly strong background and understanding in the mechanisms that at play here in the CNS that have guided our design of ADS-5102 and the concentrations we’re attempting to hit. We have published some pre-clinical evidence on that in the MS field last year, since we continue to see this consistent durable and rapid response, it nearly reinforces that those observations that we have from our prior two studies that help guide that selection where not random. That they were they things that we can rely upon and we look forward to reading that out here this quarter.
Great, thanks for taking questions and congrats again on the fantastic data.
Gregory T. Went
Thank you very much. We appreciate it Jason.
Thank you. Our next question comes from Vamil Divan with Credit Suisse. Your line is open.
Great, thanks so much for taking my questions. I guess sort of tying on to the last on the placebo, get on what we have right now and that you can publicly talk. Was there any other sort of big difference that you noticed between the two studies, I guess just from as you look at the full data, it does look pretty compare along. I was wondering is there is anything else you would point out in terms of surprises or differences between the two. And then just in terms of the regulatory submission. If you can just talk a little bit to some of the gaiting steps, I know you have given some general guideline. When we should see the submission take place, but maybe if you can just gives a little more details I mean can narrow down our expectations a little bit more on when exactly that will happen. Thanks.
Gregory T. Went
Vamil, thank you for that. I will answer the second part first and then see if Rajiv would like to handle the first part at second. With regards to the second part were still on course to the submission of an NDA in 2016, this is clearly a component that we now have in hand that we can include in that submission. We believe we have a clear path forward with the agency in terms of what we are requiring and we continue to pull very hard on the range as we assemble a high quality comprehensive Darcie across all of the individual components.
So were going to stick with the 2016 timeframe that we've set up here and I think have maintained the consistency with and look forward to moving that in as quickly as we possibly can. On the - did we defect any additional differences here between these two studies? Again, I'll comment that it's very early in the process of NOIs and the data, there is a very strong signal here in a relatively small end but just see if Rajiv would like to add anything additional.
No, just again these are top-line data and whilst yes there was a larger placebo response in the on time with troublesome Dyskinesia as reported. When we look at the totality of the data in this trial it's consistent internally, point number one. And point number two is, we begin to look at these data from our early reported trial, there is consistency across trials.
Next question please.
Our next question comes from Irina Koffler with Mizuho. Your line is open.
Congrats from me as well, can you talk about the Clinicians' Global Impression of Change, I didn't see any of these secondary end-points reported here or for any of the other studies. I mean what did doctors have to say about the difference between these patients, that's the first question and then second one is did you provide in here the number of patients on drug versus placebo in this study. Thanks.
Gregory T. Went
Irina thank you for that congratulations in the question. We provided CGIC in our prior posters, we've published that fairly extensively and in the press release, that's the first question. Do we provide specific numbers in the press release on the numbers on the drug? No. It's balanced though study and we'll include that with the poster. With regard to the specifics of CGIC Rajiv do you want to make any comments on the CGIC from the prior studies?
No, so we reported at AAN 2016 that the ADS-5102 recruitment group had a statistically significant effect versus placebo at week 12 on the CGIC and that was presented in our poster at AAN and again the CGIC data from this study are not available yet. They will be available and we'll report those at a scientific meetings.
Thank you. Our next question comes from Serge Belanger with Needham & Company. Your line is open.
Hi, good morning. Greg you have now showed consisted in I guess durable efficacy across three outcome measures in two Phase III studies, which one of the endpoints do you think is more relevant and meaningful for patients? Is it the Dyskinesia rating scale or the patient diaries?
Gregory T. Went
Serge thank you for that question. You know that is an extraordinarily important and interesting question right now. As a sponsor with the first product potentially to be launched in the Parkinson's patients population who have Levodopa-induced Dyskinesia and OFF time it’s going to be incumbent on us in the community to educate about what these three as you said consistent responses mean. Walking in, I would have answered the question that the diary data is the simplest end-point for the patients to understand, because it's reported in a single number and it has kind of a single meaning in terms of the amount of time a day you spend in each one of these diary states.
So being able to communicate to them, the reduction in the time per day, the troublesome Dyskinesia and to be able to communicate to them the reduction in OFF time, you know count on a watch in terms of the number of hours of your day you may be converting back into good ON time. And it's also a useful metric to talk about with the community at large, because you can begin to equate that with what is the seriousness, the impact of the treatment on the patient's life and on the economics of this disease.
But the more we look at the unified Dyskinesia rating scale which our primary, the more interested we become and we're going to be working very closely with the community on defining what that score means, what the individual components of that score mean and how that translates into an impact on the patient and the other stakeholders around the patients.
So it’s too early to declare, the primary is obviously extremely important, because it is the end-point which we agreed with the agency to utilize here, it is the most sensitive and specific measure we could come up with at the time. And we're pretty excited right now Serge to educate on what those results meant in that end-point and in particular what it meant to the patients in terms of their activities of daily living.
Okay, and then can you I guess provide an update on EASE LID 2, I guess how many patients have been enrolled and when should we expect to see results and I guess how do you expect it will compare to safety profile we've seen in EASE LID and EASE LID 3.
So let me just remind folks that EASE LID 2 is an open label safety extension that enrolled patients interestingly from our original EASE study. The EASE LID that we read out in December as well as EASE LID 3 that we’ve announced today, it also included patients who are not eligible to participate in those studies, who were being treated with deep brain stimulation. It was targeted to enroll about 200 subjects, the enrollment is complete. And I’ll turn over to Rajiv to answer questions on what we are measuring in that study and what he might be able to look for. Rajiv.
Yes, so again just to remind everyone, EASE LID 2 is an open label safety study so its primary objective is to characterized long-term safety of ADS-5102, number one. Number two, we are continuing to collect data on the UPDRS.
Next question please.
Our next question comes from David Amsellem with Piper Jaffray. Your line is open.
I have a couple of questions, number one is just at a high levels you talked about how you feel about the tolerability of 5102 in comparison to what we see in practice for immediate relief, amantadine given the body of data today? And then secondly, can you comment on how you think the manage care landscape or shakeout for 5102, particularly in the context of what looks like a more restrictive environment across the industry. Just wanted to get your latest thoughts on how you see that playing out? Thanks.
David thank you very much for the questions. On the first question, as you know when we initially design this formulation and based upon our understanding of the mechanism of that we felt that we are operating in the disease and the mechanism of amantadine. We attained a profile, which we thought could allow us to obtain a higher plasma level, especially in the morning and the day time hours by reducing the rate of what is the drug rose in the blood stream and giving it at nights, sort of two components to try to benefit.
And our first Phase II/III study, we ran a dose responses study in order to pick the dose. And as you just properly stated, all we had to go on was the pick-a-dose that could be of comparable tolerability to peoples’ initial experience, because peoples experience with amantadine hydrochloride in this population. People who are members of our steering committee, participated in the design of the original study was the best information we had to go on given the paucity of literature on amantadine in an LID population, back to paucity literature on any drug in this particular patient population.
So that’s why we selected the 340 milligram strength, which attends a significantly higher plasma concentration than the normal immediate release doing regiment for off label use in this population. We have been very pleased with what we seen from the safety data thus far in terms of its consistency with the expectation that were set by the community for us.
In these three studies, we see a mix of amantadine related side effects occurring with a frequency that is not dissimilar to that expectation. And again, we have here a third study where again we see the type of - we do see hallucination albeit at a lower rate, we do see dry mouth and other things. And we really kind of got back on the safety profile what we designed going in.
I think what's really the story as I transitioned to answering your next question is what surprising here is that you end up having this significant of a reduction in LID. Obtaining a significant reduction in OFF time and if you put that in context, we've spent the last couple of decades attempting to prove the OFF time in patients without worsening Dyskinesia and accepting that the add dopamine to the system inherent in their mechanism are going to create a risk of worsening Dyskinesia.
Here we now have the third result and the second statistically significantly result showing that we can improve both LID and OFF, and as you may before open the window for dopamine, so that it can have a better benefit over a longer period of the day in patients’ lives. And we got a lot of positive feedback on that at AAN from the assembled thought leader community in addition to some of the neurologist we met with and talked with there.
So to conclude, it's been a passion of mind for over a decade right now to provide this kind of innovation to the market and benefit all of the stakeholders. This was not an attempt to merely improve convenience of an existing drug this was an attempt to take a drug that we felt was underutilized and there is relatively little use of an amantadine in the Parkinson's population to go into an indication for which those no drug therapy approved. And patients at this point in their lives are really facing greater than half of their day in bad ON time a combination of Dyskinesia and OFF.
And their only remedies right now are interventional and very expensive. So as we go through and work through our strategy and interact with managed care providing access to this product in a way that benefits the patients, the care givers, the physicians and the payer is going to be an important next step in this program. And an important step in the development of Adamas as someone who creates value for the system.
Next question please.
[Operator Instructions] And our next question comes from Tim Lugo with William Blair. Your line is open.
This is [indiscernible] for Tim. Thanks for taking the questions. Can you provide just the base line raw values for the unified Dyskinesia rating scale on both this and EASE LID trail and then regarding the long-term safety study are you going to expect to have all 12-months for all the patients in the NDA submission or is it going to be a shorter duration in all the patients and are there any doses adjusts allowed in that study. Thanks.
Gregory T. Went
Wow. Okay that’s an arm full. Thank you for the question. I'll go backwards, because then you remind what the first one was. We did permit those adjustments in the open label extension, we really wanted to get as close to a real world studying as we could in that and as Rajiv mentioned we are looking at both primarily and safety, but will be monitoring the UPDRS in it.
With regards to the filing requirements coming out of that study, we don’t provide specifics on the data that’s required for our NDA submission, for a new drug in a new indication like this there are guidelines for industry that are provided on that topic and we believe we have an understanding of what we will submit, but we haven’t provided the specifics on that. We are just confident that we will have that sufficient data and the package submitted here in 2016. There was a first question, baseline UDys. We didn’t provide that yet, I will tell you it's consistent across all the three studies.
Great, thanks for answering all the questions.
Thank you. And our next question comes from Ken Cacciatore with Cowen and Company. Your line is open.
Great, thanks. Congratulations guys as well fantastic data. Just Greg you went into a little bit but maybe helpful as we try to put in perspective the side effect profile, can you just talk about the concept of these patients in terms of their need to start the you escalating their dopamine levodopa dose. And then also maybe the concept with this drug of being able to escalate the dose and to put into context kind of who these patients are, you dig it a little bit, maybe to just emphasize it vis-à-vis side effect profile. So when this drug would be helpful and be used and then also maybe just talk about commercialization efforts sales force size and the like. Thank you.
Gregory T. Went
Ken, thank you very much for your kind words and for your question. It's a very important thing not to lose a track of there. About a million patients in the U.S. with Parkinson's disease. When you are diagnosed it is a extremely difficult moment in your life there has been a couple of years leading into it that you have hints that something is not quite right but when you are diagnosed it's an extremely difficult moment.
Then there was a period of time as they are adjusting to what is going to be a life long journey where the physicians refer to them as being well controlled on Levodopa, meaning you get to the point where you are diagnosed, where you have lost probably three quarters of your dopamine produced production ability of dopamine producing neurons, symptom show up.
And the physician can put them on a normal call it a lowest dose probably Levodopa and the patient can experience a period of time we've heard it called a honeymoon, where they are well controlled and as we go through our everyday lives we encounter these patients without really seeing an impairment at all in the patients.
As that irreversible decay continues though we began to see the population we've become familiar with and it really is a - becomes impossible to maintain the movements because of the inability to obtain a balanced response by just adding in Levodopa. And so you see the phenomena of wearing off episodes and as the patients and physician try to correct those by adding more forms of dopamine, you see the risk of creating Dyskinesia. And this is dose limiting risk of Dyskinesia that begins to constrain what the physicians can do with these patients and send them down a path to increasing amounts of OFF time and dsykinetic time to which their only remedy towards the end, which produces impressive results I might add is deep brain stimulation.
Deep brain stimulation does an excellent job of restoring the balance, electrical balance in the brain for several more years as the patients are moving through their final journey. So we see these results in the context of the point that these fluctuations and what are called motor complications occur as Dyskinesia comes in. As providing physicians potentially if approved a very important tool that expands that window both in dose of Levodopa or other dopamine sources as well as in time and working with their patients, so they can give their patients back a significant portion of the day that they have lost to this decay to this imbalance which results from the neuro degeneration.
And we'll be talking more and more about this Ken and publishing more about it as time goes on here about why this occurs with 5102 specifically as we bring this forward. That transitions into we are setting up to mounts an education effort and a promotional effort around ADS-5102 to the movement disorder community who has worked extremely closely with the company in helping us design this first successful trial design to get a product, get a data set that could be submitted for approval.
We will be focusing on them, we will be looking at the neurologists who are treating significant numbers of Parkinson's patients on levodopa who want to continue to provide treatment before needing to refer them up for more specialized support and we’ve maintained looking at the data that we have in front of us today.
That’s you know somewhere an effort that involves somewhere between 40 and 60 Adamas representatives will be sufficient at launch to get to the treating population, a significant fraction greater than half of the treating population that we need to get to with direct promotional effort. And we'll augment that of course with a measured commercial investment that will enable us to both provide this medication as well as do so in a financially responsible way that allows us to you know maximize our returns and our ability to continue to invest in our pipeline.
Great, thank you.
Thank you, I’m showing no further questions at this time, I would like to turn the call back to Dr. Went for any closing remarks.
Gregory T. Went
So thank you everyone for, I know you are up already but making time to join us in this very busy day. We are clearly very pleased with this our third results and we really are impressed with the properties that this ADS-5102 product candidate has demonstrated. Our focus the focus since I started the company has been on patients on delivering important medicines to them and making sure that the community at large benefits from them. So we ask you to stay tuned we expect to have data from the proof of concept study in MS patients coming up later this quarter as we proceed with our NDA submission in ADS-5102 and LID in 2016. Thank you very much.
Ladies and gentlemen thank you for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a great day.
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