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Acceleron Pharma Inc (XLRN)
Q1Â 2019 Earnings Call
May. 9, 2019, 5:00 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon, ladies and gentlemen, and welcome to the Acceleron First Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. As a reminder, this conference call is being recorded.
I would now like to hand the call over to Mr. Todd James, Vice President, Investor Relations and Corporate Communications at Acceleron. Please go ahead.
Todd James -- Vice President, Investor Relations and Corporate Communications
Thanks, and welcome everyone to our first quarter 2019 earnings call. The press release reporting our financial results in addition to the presentation for today's webcast are available on the Investors and Media page of the corporate website at www.acceleronpharma.com. Joining me for the call today are Habib Dable, our Chief Executive Officer; Kevin McLaughlin, our Chief Financial Officer; John Quisel, our Chief Business Officer; and Sujay Kango, our Chief Commercial Officer. As a reminder, we will be making forward-looking statements regarding our financial outlook in addition to regulatory and product development plans and research activities. These statements are subject to risks and uncertainties that may cause actual results to materially differ from those forecasted. A description of these risks can be found in our most recent Form 10-K on file with the SEC.
I would now like to turn the call over to Habib Dable, our Chief Executive Officer.
Habib Dable -- President and Chief Executive Officer
Great. Thank you, Todd, and good afternoon, everyone and thank you for joining us today. We made significant progress across the entire pipeline positioning Acceleron to execute effectively over a year that will include key milestones in all of our clinical programs. In fact because of this progress I'm pleased to say that today we have one of the industry's most advanced TGF-beta superfamily based pipelines spanning three disease areas.
Let's begin with Luspatercept, our first-in-class erythroid maturation agent in hematology. We and our global collaboration partner, Celgene, recently submitted marketing applications in the US and EU and lower risk myelodysplastic syndromes or MDS and transfusion-dependent beta-thalassemia based on the positive Phase 3 safety and efficacy results from the MEDALIST and BELIEVE trials that we reported last year. If approved, this will be the first Acceleron discovered drug to be available for patients and I could not be more excited or proud of all of the effort and work the teams have dedicated to this program to reach this point. We are also evaluating Luspatercept in additional MDS in beta-thalassemia patient populations in the commands and beyond trials and are conducting a trial in patients with myelofibrosis associated anemia.
In neuromuscular disease, we are currently evaluating our locally acting therapy ACE-083 in two Phase 2 trials for FSHD and CMT, diseases that are both associated with slowly progressing focal muscle weakness leading to meaningful loss of function for which there are no approved medicines. In pulmonary disease both our PULSAR and SPECTRA trials are evaluating sotatercept in patients with pulmonary arterial hypertension or PAH, a devastating and progressive disease in which deficient BMPR2 signaling causes pulmonary vascular remodeling leading to right heart failure.
Focusing more closely on Luspatercept , in April, our partner Celgene submitted the Biologics License Application or BLA to the FDA and the Marketing Authorization Application or MAA to the EMA. The joint teams are committed to the successful execution of all of the planned upcoming regulatory and commercial activities in an effort to get this new treatment option to patients as quickly as possible.
To put a potential approval in context, there are currently no medicines approved to treat MDS or beta-thalassemia associated anemia in the United States. And it's important to recognize the true impact, chronic anemia has on a person's life. Due to the effects of anemia, patients are often limited in completing normal everyday activities and they frequently experience significant fatigue and exhaustion along with dizziness and shortness of breath after completing these activities. Patients have like in the feeling to climbing up a long steep hill with a 50 pound weight on their backs. Anemia can also impact mental acuity. Due to limited treatment options, a majority of patients require frequent red blood cell transfusions to help manage their disease. We believe that Luspatercept could bring market improvements to patients with these conditions by potentially decreasing transfusion burden.
As I mentioned earlier, we also continue to explore Luspatercept's potential and additional patient populations. Similar to the MEDALIST and BELIEVE patient populations there are no medicines approved for patients with treatment naive lower risk MDS, non-transfusion dependent beta-thalassemia and myelofibrosis associated anemias. We are looking forward to results from all three ongoing trials, beginning with the preliminary top line results from the myelofibrosis Phase 2 trial in the second half of this year. Based on the high unmet medical need in all patient populations under evaluation across the Luspatercept program, we and Celgene estimate that the annual global peak sales potential for Luspatercept exceeds $2 billion for the MDS and beta-thalassemia indications alone. We also estimate up to an additional $1 billion of global peak sales potential for the opportunity in myelofibrosis associated anemia. With our low to mid 20% tiered royalty rate these peak sales estimates have the potential to translate to significant royalty revenue for Acceleron.
I'd now like to move to our wholly owned candidates beginning with our neuromuscular program. Last month at the Muscular Dystrophy Association or MDA, Clinical and Scientific Conference, we highlighted previously presented results from part one of the Phase 2 trial of ACE-083 in patients with FSHD. We expect top line results from Part 2 of the trial in the second half of 2019. Additionally, we'll be sharing previously presented results from Part 1 of the Phase 2 trials evaluating ACE-083 with CMT during a platform presentation at the American Academy of Neurology's 71st Annual Meeting tomorrow. Enrollment is ongoing in Part 2 of our CMT trial.
Turning to PAH, enrollment is ongoing in PULSAR, our Phase 2 randomized, double-blind, placebo-controlled trial. At the same time, we are enrolling patients in SPECTRA, our Phase 2 exploratory, open-label, single arm study. We look forward to presenting a pre-clinical abstract of sotatercept in PAH later this month at the American Thoracic Society ATS 2019 International Conference.
With that, I will turn the call over to Kevin McLaughlin, our CFO to review the financials.
Kevin McLaughlin -- Chief Financial Officer
Thanks, Habib. Good afternoon, everyone. Our cash, cash equivalents and investments as of March 31st, 2019 were $513.1 million. This compares to December 31st, 2018, cash, cash equivalents and investments of $291.3 million. Based on our current operating plan and projections, we believe that current cash, cash equivalents and investments will be sufficient to fund projected operating requirements until such time as we expect to receive significant royalty revenue from Luspatercept sales. Collaboration revenue for the first quarter was $2.8 million. The revenue was all from our Celgene partnership and it's primarily related to expenses incurred by the company and support of Luspatercept. Total costs and expenses for the first quarter were $43.6 million, this includes R&D expenses of $32.8 million, and G&A expenses of $10.8 million. The company posted a net loss for the first quarter ended March 31st, 2019 of $38.1 million.
I will now turn the presentation back over to Habib for final remarks.
Habib Dable -- President and Chief Executive Officer
Thanks, Kevin. With that, I will briefly summarize our priorities for the remainder of this year and beyond. Beginning with Luspatercept and hematology, in addition to upcoming regulatory activities following the BLA and MAA submissions, we and Celgene are looking forward to submitting MEDALIST and BELIEVE Phase 3 trial results for publication this year. We also anticipate preliminary top line results from the Phase 2 Myelofibrosis trial in the second half of this year as well as top line results from the Phase 2 beyond trial in 2020, while the Phase 3 COMMANDS trial continues to enroll patients. We also continue to evaluate potential opportunities to expand Luspatercept's development in traditional diseases associated with anemia. Looking at our neuromuscular program with ACE-083, we expect top line results from Part 2 of our Phase 2 FSHD trial in the second half of 2019, and top line results from Part 2 of our Phase 2 CMT trial in the first quarter of 2020. Lastly for PAH, we expect to provide top line results for PULSAR trial in the first half of 2020 and preliminary results from the SPECTRA exploratory trial in 2020.
I will now open the call to questions. Operator?
Questions and Answers:
Operator
Thank you, sir. (Operator Instructions) Our first question comes from Carter Gould from UBS. Please go ahead.
Carter Gould -- UBS -- Analyst
Hey, good afternoon. Thanks for taking the questions. Habib, I saw the open-label extension study for ACE-083 got out of the clinical trials, but I guess earlier today kind of interesting how that's going to play out if patients roll off Part 2 of the Phase 2 studies. But I guess my specific question is, I believe the open-label extension is exploring every 4-week and every 8-week dosing. Is there any data specifically supporting that 8-week dosing. And I guess a larger question is when you think about potentially moving into a Phase 3 study, how important is it to have a defined less frequent maintenance strategy in place? I've got a follow-up.
Habib Dable -- President and Chief Executive Officer
Okay. Hey, Gould, thanks for the question. Yeah, so with respect to the extension study just to remind everyone, Part 2 of both the CMT and FSHD studies are designed in a way to once again show safety and tolerability as well as total muscle volume is the primary endpoint. But most importantly we're going to be looking at a number of secondary endpoints regarding function. Now, in anticipation of a successful study, what we would need to do then is to move forward and to understand, if indeed we have a positive study, how do we optimize ACE-083 for the patients. And based on the research that we've done to date, Carter, what we've learned is that the most important thing is for the drug to work i.e. for to build healthy muscle and for that to translate into a functional benefit and we define that as a benefit of at least 10% or more across the number of endpoints. That's the most important answer that we need to get to with Part 2 of the study and we look forward to seeing those results. But what we've also heard is that, if indeed we had a successful drug, it would be optimal to find opportunities to make it more convenient. And so what we're exploring in the extension study is 2 dosing regimens of q4 weeks and q8 weeks. And we're going to follow the patients and we're going to see if indeed after the primary endpoint has been established, if indeed that we have durability of the drug. And so -- and that's really based on some of the data that we've seen when we look at Part 1 of the study. Again, we don't have any functional benefits and durability that we can look at, but we have been taking a good close look at total muscle volume from the 3 weeks after the last dose as well as 8 weeks after the last dose and is reasons to believe that we'd be prudent in exploring kind of an extension study and that's exactly what we're doing.
Carter Gould -- UBS -- Analyst
Great. That's helpful. And I guess now with 2494 having been discontinued I guess it also makes us the question if ACE-083 unfortunately would disappoint, what does it do around your commitments to neuromuscular and I guess your commitments to having sort of 3 legs to the store around potential therapeutic areas you'd be pursuing?
Habib Dable -- President and Chief Executive Officer
Yeah. Yeah, so again thanks for the question. So as you know we recently announced the termination of the 2494 study. Again that was our healthy volunteer study with our systemic agent. And unfortunately, we saw emergence of ADAs that were unexpected and we ended up terminating the study. Now the most important thing is we feel very confident that there isn't any read-through into ACE-083 or locally acting agent that we just talked about. But your question is more of a strategic one that if indeed we are not successful with 083, what would be the future for our company as well as a therapeutic area within neuromuscular. What I can tell you right now, we're not pursuing a backup candidate for 2494 systemically, we are going to wait and see how 083 plays out, and based on the findings and the learnings that we get from 083, we'll reassess. But there is no commitment at this point that we're going to find a backup for the systemic agent of 2494. So let's wait and see.
Carter Gould -- UBS -- Analyst
Great. Thanks for all the answers.
Habib Dable -- President and Chief Executive Officer
Yes. Thanks, Carter.
Operator
Thank you. Our next question comes from Geoffrey Porges from SVB. Please go ahead.
Andrew Berens -- SVB -- Analyst
Hey, thanks for the question. This is Andrew on for Geoffrey. A few question regarding the recent discontinued program...
Habib Dable -- President and Chief Executive Officer
Hey, sorry to interrupt, but it's really hard to hear you. Could you speak up?
Andrew Berens -- SVB -- Analyst
Yeah, hi. Can you hear me now?
Habib Dable -- President and Chief Executive Officer
A little bit better, yeah.
Andrew Berens -- SVB -- Analyst
Okay, sorry. So a few questions on the program 2494 as well. So, we -- I mean, regarding the R&D expenses, so we expect the expenses running down this year due to the discontinuation of this program?
Todd James -- Vice President, Investor Relations and Corporate Communications
Hey it's Todd. Yeah, so as far as R&D expense goes, so 2494 Phase 1 healthy volunteer study as far as the development expenses go across the entire portfolio, Phase 1 pretty low, there will be some trailing expenses as the team continues to wind down the study and look at the data more closely over time. But as far as 2494 goes off the books really, really soon, but as you can imagine with the two larger Part 2 both CMT and FSHD ongoing, the kick-off of the extension studies for both those disease areas, the PULSAR Phase 2 trial in PAH now having a lot of the patients on study and the kick-off of the SPECTRA study. This is a really important time for us across all the trials, so those expenses even with 2494 coming off will be going up this year.
Andrew Berens -- SVB -- Analyst
Okay, thank you. That's helpful. Another question is about, so what impact do you believe that the development of HIF inhibitors might have on the opportunity for Luspatercept and MDS, particularly in frontline patients, would you -- I mean would you expect HIF inhibitor to work in EHA no responses as well?
Habib Dable -- President and Chief Executive Officer
Yeah, so this is Habib. Thanks for the question. So if I understand your question correctly, you're wondering if the HIF are going to have a role in whether or not they're going to be a competitor either ESAs or Luspatercept. So our understanding of the HIF is that they could play a very significant role for patients who are suffering from low endogenous EPO levels based on their mechanism of action, based on their inhibition of hepatitis again could potentially play a role in competing with ESAs where Luspatercept is really finding its niche and we hope if approved will establish that niche, is really in dealing with patients who actually aren't suffering from low endogenous EPO levels and really are really faced with anemia due to the fact that they have a late-stage maturation defect due to the various ligands within the TGF-beta superfamily that are inhibiting the appropriate healthy red blood cell formation in these patients. And that's really where we play a role. And so in terms of really the upfront setting, we are going head-to-head in a Phase 3 study, the COMMANDS study which is going to be designed and it is designed in a superiority designed way to show efficacy against ESAs. And we're banking on our track record of predictability of our Phase 2 translated into success into Phase 3. And again if you look at what we were able to establish with the MEDALIST and BELIEVE studies which was really hinged on the information gathered from the PACE studies and the Phase 2 studies in beta-thalassemia, we were able to show the predictive nature and the success that we did, we established in this patient population and replicated it in Phase 3. In the frontline study in terms of your question specifically, we were able in the COMMANDS like patient population to show a 56% response rate. Now although that we're going to be looking at some different endpoints for example we're going to be looking at patients who are going to be transfusion independent for 24 full weeks as the primary endpoint, we feel very confident that if successful that we'll be able to position Luspatercept as a frontline setting drug in that population.
Andrew Berens -- SVB -- Analyst
Thank you. That's helpful.
Operator
Thank you. Our next question comes from Yaron Werber from Cowen. Please go ahead.
Leo -- Cowen -- Analyst
Good afternoon. This is Leo in for Yaron. Thanks for taking the questions. I just have two questions regarding the Sotatercept in PAH. So what do you expect the Phase 2 PULSAR that it would show and can you remind us the powering of this study on the primary endpoint as well as the secondary endpoint? Thank you.
Habib Dable -- President and Chief Executive Officer
Yeah, thanks for your question. So, I'm going to pass the question onto our Chief Business Officer, Dr. John Quisel, who has been very involved in this project. John?
John Quisel -- Chief Business Officer
Yeah, hi, thanks Habib. So on the PULSAR trial primary endpoint is pulmonary vascular resistance PVR and we're looking for a decrease of at least 20% in the PVR which represents an improvement in function for the patients. And then we have an important secondary -- key secondary endpoint of six-minute walk where we're looking for an improvement in of 30 meters. As to the powering, we have not disclosed the powering for the trial.
Leo -- Cowen -- Analyst
I see. That's very helpful. Thank you.
Habib Dable -- President and Chief Executive Officer
Leo.
Operator
Thank you. Our next question comes from Danielle Brill from Piper Jaffray. Please go ahead.
Nirav Shelat -- Piper Jaffray -- Analyst
Hi, guys. This is Nirav Shelat on for Danielle Brill. I just had a couple of quick questions. The first was -- so from what we've been hearing BMS like Luspatercept is most enthusiastic about it from Celgene's entire pipeline right now. So we were wondering, if you -- you've had any interactions with them about what your thoughts are on the commercial plans, if there's been any sort of shift in commercial strategy for this?
Habib Dable -- President and Chief Executive Officer
Yeah. Hey, thanks for the question. And I would have to say from our vantage point that we would concur with that sentiment from everything that we're seeing on the sidelines, all signals point that Luspatercept is going to be a very important asset in their portfolio. I can tell you right now that everything that we're seeing in terms of the project teams, the momentum that's associated with an important filing and hopefully approval and preparations for launch, signal that all parties involved very much have their eye on the ball and I can tell you as the CEO of Acceleron, I couldn't be more pleased with all of the efforts behind all of the efforts on Luspatercept. With respect to specific discussions, no, we have not had direct conversations with BMS, but at the appropriate time, we very much look forward to working closely with them to make sure that we continue on the already established positive momentum for Luspatercept.
Nirav Shelat -- Piper Jaffray -- Analyst
Great. Thank you. And the second question I had was just -- can you remind us on the EU approval process or shouldn't we expect a decision to be made and when would launch be?
Habib Dable -- President and Chief Executive Officer
Yeah, so again we were pleased to share the submission of both the BLA in the US as well as the MAA in Europe for April. Again with the US timelines as you're probably already aware under a standard review that would take us into April of next year. But if we were fortunate enough to have a priority review that would shave three or four months off of that timeline. With respect to Europe, it's a little bit of a longer process and our expectations are that, if everything goes well that we would be looking at a potential approval in Europe in the second half of 2020.
Nirav Shelat -- Piper Jaffray -- Analyst
Great. Thank you so much. Really appreciate the answer.
Habib Dable -- President and Chief Executive Officer
Yes, thanks for the question.
Operator
Thank you. Our next question comes from Geoff Meacham from Barclays. Please go ahead.
Greg Harrison -- Barclays -- Analyst
Hi, this is Greg Harrison on for Jeff. Thanks for taking the question. So from a commercial standpoint there is a clear patient pool of individuals with MDS and beta-thal. But there could still likely be some launch challenges given the lack of other treatments that you need to build the market. Can you discuss the pushes and pulls here and what are your expectations and as you approach the launch, what factors should we look at to gauge how well uptake is going?
Habib Dable -- President and Chief Executive Officer
Right. So I'm going to ask our Chief Commercial Officer, Sujay Kango to tackle at least some of the portions of that question. Obviously, we're not going to able to answer all of that in a level of detail, that I'm sure you'd want at this point, but Sujay I think you can give some top line.
Sujay Kango -- Chief Commercial Officer
Sure. Thank you, Habib. So yeah, I mean from a launch readiness and preparation as you can imagine we clearly have done a lot of inside gathering with peers, with physicians, as well as the patient advocacy groups to understand where the true unmet needs are. And as you sort of articulated right there is a large gap from the last approved therapy, which is about a decade ago to the current timelines, right. So there is a significant amount of a patient population and the need particularly for those patients who are not eligible for ESAs and/or have failed and the transfusion dependent, right. So this is the sweet spot for the patient population that there's a huge need for a new treatment and if and when we are approved we would be able to fill that gap and the unmet need for the patient population.So that's the pool that we see as the unmet need. Of course in a launch this is a new disease sort of therapeutic class of drugs and medicines. So we'll have to educate the market about the variations and the differences in relation to the therapy as, as it would be for any new molecule that comes into the market. So that's not unusual from that fact of the matter. So we anticipate we'll be able to do that quite rapidly with our partner, Celgene, who has a significant amount of experience in the field of hematology, right.
Greg Harrison -- Barclays -- Analyst
Great. Thanks, Sujay.
Sujay Kango -- Chief Commercial Officer
Thanks.
Operator
Thank you. Our next question comes from Jeff Hung from Morgan Stanley. Please go ahead.
Ishmael Asante -- Morgan Stanley -- Analyst
Hi, this is Ishmael on for Jeff. Thank you for taking our questions. Two quick ones. Can you remind us of what we should expect from the MF data and what you would consider to be clinically meaningful and then I have a follow-up after that. Thank you.
Todd James -- Vice President, Investor Relations and Corporate Communications
Sure. Hi, it's Todd. Yeah. So we're currently in a ongoing Phase 2 Myelofibrosis study. We're looking across multiple patient populations, cohort 1 is a monotherapy Luspatercept cohort with patients just anemia only, no transfusion burden. Cohort 2 is also Luspatercept monotherapy but the patients have a baseline transfusion burden of two to four units per 4 weeks and then those same style patients in combination with ruxolitinib in cohorts 3a and cohorts 3b. The primary endpoint -- if the patient is anemia only as a gram-and-a-half increase of hemoglobin over a 12-week period sustained within the 24 weeks, and then for the transfusion-dependent patients it's transfusion independence sustained for consecutive 12-week period within the 24 weeks. So what we saw with our sister molecule sotatercept in an IST is greater than 30% response rate in both monotherapy and combination therapy in those cohorts. What the clinically meaningful proportionate patients for the bar, we think that 25% to 30% response rate in any of the patient populations would be success and so we'll have to look at what the data shows and that would potentially put us in a place to do either really broad Phase 3 trial or very selective Phase 3 trial or even multiple Phase 3 trials across multiple patient populations. So I have to wait and see that data in the second half of the year.
Ishmael Asante -- Morgan Stanley -- Analyst
Very helpful. Thank you. And secondly could you speak to the ACE-083 CMT data now expected in the first quarter of 2020 and sort of this year. What have you learned about enrollment that might have resulted in the updated view? Thank you.
Habib Dable -- President and Chief Executive Officer
Yeah. So great question. So we had always said FSHD would be reading out in the second half and deliberately knowing that the timeline for CMT pegged it for year-end. And so basically the learnings what we are finding is that the recruitment and quite frankly the screen failure rates were little bit higher than we had expected. And we now have just moved the timeline from year-end to the first quarter. So it's a change, but it's a slight change.
Greg Harrison -- Barclays -- Analyst
Great. Thank you for the color.
Operator
Thank you. Our next question comes from Kennen MacKay from RBC Capital Markets. Please go ahead.
Kennen MacKay -- RBC Capital Markets -- Analyst
Hi, thanks for taking the question. Wondering if maybe you could just help us understand as we think about the ACE-083 update coming and sort of getting and look at muscle function and muscle strength here, if you could help us understand what's considered clinically meaningful in these settings. And then maybe just going back to some of your data there was -- from this molecule does that the 2019 Muscular Dystrophy Association conference. Wondering if that's sort of data surrounding volume growth in these patients at baseline submissions with FSHD, if that volume growth sort of give you increased confidence around the link between that muscle function and really how we should be thinking about that translating. Thank you very much.
Habib Dable -- President and Chief Executive Officer
Sure. Yeah, hey, Kennen, it's Habib. Thanks for the question. So let me start with the second question first. So we -- I think it's been pretty consistent Kennen in our confidence that ACE-083 through its mechanism of actions to its sequestration beyond GDF8 through the mechanism of being a direct intramuscular injection, that we can -- with confidence grow healthy lean muscle. We've been able to demonstrate that repeatedly across different diseases. And what you saw most recently with a confirmation of that and showing to my knowledge unprecedented muscle growth and the double-digits. The question remains though as to whether or not we'll be able to translate that into a functional benefit and indeed if we cannot do that, we do not have a drug. Now what is clinically meaningful is the first part of your question. And where are we going to be looking for? And because of the fact that we've powered the study, again, the Part 2 to be able to, to again show us in a statistically significant way that we can grow healthy lean muscle. We also want to see on a number of factors, what is that some of those functional benefits that we would look for and how much do we need to see. And so for example, with the tibialis anterior muscle, so again just to remind everyone in both diseases FSHD and CMT were dosing patients who have put drop who have weakness in the dominant muscle causing that foot drop, the tibialis anterior muscle. And so what we've done is we've looked at a number of functional parameters for foot drop and the associated disabilities for foot drop. So we're looking at 6-minute walk distance, we're looking at 10-meter walk run, we're looking at four stair climb, et cetera, et cetera. And so what we want to be able to see in combination with those functional benefits, we also have what we call the FSHD HI or the health index inventory that we were great -- with the University of Rochester, which is really going to be a validated PRO that we're going to be looking at in combination with these measurements as well as with the muscle increases that we hope to see. And if we can see benefits and trends in the double digits of 10% or more across a number of these parameters, then we feel that will have a clinically meaningful drug and that will very much inform us on what we're going to do in Phase 3. Now as I spoke with Carter earlier from UBS, we're also running an extension study, because what we also want to find out is not only that the drug work -- could the drug work, but could it work in a way that's conducive to patients getting injected every 3 weeks, every 4 weeks or maybe even every eight weeks. But what we have learned repeatedly is that the most important thing is not the muscle growth and it's not the dosing interval, it's can you show unambiguous functional benefit and that's what we're trying to answer.
Kennen MacKay -- RBC Capital Markets -- Analyst
Got it. Thanks, Habib. Maybe just going back to again some of that data that was at the Muscular Dystrophy Association meeting, I guess thinking about sort of the -- I guess it depends on the slope of those curves a bit tied the increase in muscle volume to the increase in muscle strength across those endpoints that you've referred to walk, FSHD, mobility, and ambulation. I guess with the double-digit improvement in muscle volume, should we be expecting a double-digit improvement in muscle strength as well or at least on those endpoints or --?
Habib Dable -- President and Chief Executive Officer
Yeah, We cannot conclude that we would hope that that's the case. What we can say, Kennen, is if you look back at some of the previous studies with the systemic agents when you were seeing increases systemically of 4%, 5%, 6% there was functional improvement of 4%, 5%, 6%. Now is that enough for us to draw a direct correlation that if we see double-digit increases in muscle mass that will be in function. I hope so, but we cannot conclude that at this point.
Kennen MacKay -- RBC Capital Markets -- Analyst
Got you.
Kevin McLaughlin -- Chief Financial Officer
Yes. And Kennen specific to the MDA presentations we did do some baseline correlations across some of the tests but really scientifically interesting but nothing can really be taken away from that. No surprise. There are correlations between having a good 6-minute walk test and having a good 10-meter walk around at baseline. Some correlations between the quality of muscle and your ability to do the 10-meter walk run. But we're really close to the data at this point as far as patients on treatment and versus placebo. So let's see how that data reads out here for FSHD in the second half.
Kennen MacKay -- RBC Capital Markets -- Analyst
Got you. Thanks for taking the questions guys.
Habib Dable -- President and Chief Executive Officer
Yes. Thanks, Kennen.
Operator
Thank you. I show no further questions in the queue. At this time, I would like to turn the call over to Habib Dable, CEO for closing remarks. Please go ahead.
Habib Dable -- President and Chief Executive Officer
Yeah, great. Thank you again. I just want to thank everybody for your continued interest in our company. The next six to 12 months are obviously going to be very important time at Acceleron as we prepare for the launch of Luspatercept as well as the results from a number of our clinical trials and very much look forward to meeting many of you at the upcoming conferences. So with that, wish everybody a great night.
Operator
Thank you, ladies and gentlemen for attending today's conference. This concludes the program. You may all disconnect. Good day.
Duration: 35 minutes
Call participants:
Todd James -- Vice President, Investor Relations and Corporate Communications
Habib Dable -- President and Chief Executive Officer
Kevin McLaughlin -- Chief Financial Officer
John Quisel -- Chief Business Officer
Sujay Kango -- Chief Commercial Officer
Carter Gould -- UBS -- Analyst
Andrew Berens -- SVB -- Analyst
Leo -- Cowen -- Analyst
Nirav Shelat -- Piper Jaffray -- Analyst
Greg Harrison -- Barclays -- Analyst
Ishmael Asante -- Morgan Stanley -- Analyst
Kennen MacKay -- RBC Capital Markets -- Analyst
