Good morning, ladies and gentlemen, and welcome to the Viridian Therapeutics Conference Call. At this time, 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 will now hand the conference over to Greg Rossino, Senior Director of Investor Relations at Viridian. Please go ahead.
Thank you, Leah, and good morning, everyone. Thank you for joining us to discuss Viridian's VRDN-008 phase I results and FcRn portfolio plans. You can access the press release and slides for today's call on the Investors page of our corporate website at viridiantherapeutics.com. Before we begin, I'd like to remind everyone that today's call and webcast will contain forward-looking statements, including statements about our portfolio plans.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from those forecasted. A description of these risks can be found in the forward-looking statement disclaimer in the press release and slides issued today, as well as our SEC filings, including our Form 10-K, 8-K. With me today are Steve Mahoney, our President and Chief Executive Officer, Radhika Tripuraneni, our Chief Medical Officer, and Shan Wu, our Chief Business Officer. With that, I'll turn the call over to Steve.
Thanks, Greg, and good morning, everyone. Thank you for joining us to discuss the VRDN-008 phase I results. We are really excited to announce that VRDN-008, our half-life extended FcRn inhibitor, when delivered subcutaneously, demonstrated what we view is a potential best-in-class FcRn profile. We believe subcutaneous VRDN-008 can deliver deep and sustained IgG reductions with an every eight-week dosing regimen, which represents a highly differentiated FcRn-targeted therapy for patients.
Based on the strong VRDN-008 product profile, we plan to progress directly into pivotal development, initiating at least one registrational trial in 2027, starting with myasthenia gravis in mid-2027. Now, let's briefly revisit the VRDN-008 molecule and the target product profile.
VRDN-008 is licensed from Paragon Therapeutics and is a bifunctional molecule comprising an Fc fragment with an albumin-binding domain, designed to replicate the established efficacy and safety of Fc fragments while delivering sustained reduction of the pathogenic antibodies that drive autoimmune disease. Very proud to say that subcutaneous VRDN-008, with the data today, has exceeded our target product profile, demonstrating a half-life of 15- 18 days, which is up to 6x longer than those of first-generation Fc fragments.
This led to deep and sustained IgG reductions through eight weeks after dosing in healthy volunteers, with 74% IgG reduction at peak, supporting a potential every eight-week dosing schedule. VRDN-008 also demonstrated a safety profile that spared albumin and LDL and was generally well tolerated, with no serious adverse events or dose-limiting toxicities. With that, I will turn it over to Radhika Tripuraneni to present the data in more detail.
Thank you, Steve. As mentioned, we are highly encouraged by this initial VRDN-008 clinical data. We are the first to show clinical PK and PD data for a half-life extended FcRn inhibitor, and we believe these results are best in class. In this phase I clinical trial, healthy volunteers were dosed with subcutaneous VRDN-008. The graphs here show PK and PD data after two doses, one administered at the start of the study and another one at week four.
As you can see on the left, this data demonstrates a half-life for VRDN-008 of 15- 18 days, which we believe is a highly distinct and differentiated PK profile for VRDN-008 relative to all other first-generation FcRn inhibitors. For reference, VYVGART, the current FcRn market leader, has a half-life of 3-5 days, as described on their label.
On the right, IgG reductions were rapid and sustained through eight weeks after dosing, achieving a peak reduction of 74%, which has historically translated to strong clinical performance for first-generation FcRn inhibitors. This profile exceeds expectations and unlocks for VRDN-008 to be dosed subcutaneously every eight weeks.
As you know, the standard of care for FcRn inhibitors is weekly dosing. We believe VRDN-008's sustained response has the potential to transform FcRn treatment for patients by providing disease control with substantially greater dosing convenience. On to safety. VRDN-008 demonstrated a safety profile that spared albumin and LDL and was generally well tolerated. There were no serious adverse events or any dose-limiting toxicities observed in the trial, which is a great place to be.
With these data in hand, we modeled the response of IgG reduction with every four-week and every eight-week subcutaneous dosing for VRDN-008. When we designed VRDN-008, we set out to develop an FcRn inhibitor capable of Q4 weekly dosing. Our PK/PD data and modeling clearly demonstrate that we have surpassed that goal, enabling a potential Q8 weekly dosing regimen that sustains IgG reductions, exceeding our expectations.
In fact, our model shows that every eight-week dosing of VRDN-008 surpasses the peak IgG reduction seen with first-generation Fc fragments. We are excited to advance the Q8 weekly subcutaneous VRDN-008 regimen into registrational studies, starting with MG. Let me now walk you through our registrational plans. We plan to initiate at least one registrational trial in 2027, starting with myasthenia gravis in mid-2027, assessing every four-week and every eight-week subcutaneous dosing versus placebo.
The study will be randomized one-to-one-to-one with MG-ADL as the primary endpoint. MG is a natural first indication for VRDN-008. As you know, FcRn inhibition is a well-established mechanism in MG, with a clear link between IgG reduction and clinical benefit, and we believe MG patients are in need of more convenient treatment options.
We believe this validated mechanism, our strong VRDN-008 data, and our study design with two active dosing arms provide a path to move directly from phase I to a registrational trial, pending regulatory feedback. I will now turn it over to Shan to talk more about the VRDN-008 profile and the broader opportunity.
Thanks so much, Radhika. I would like to start by reiterating what we have here with VRDN-008. We engineered VRDN-008 to be a subcutaneous, half-life-extended FcRn inhibitor, and today, we showed that subcutaneous VRDN-008 can drive deep and sustained IgG reductions, supporting a potential best-in-class every eight-week dosing regimen. Now let us think about VRDN-008 in the context of the current FcRn treatment landscape.
There are a number of FcRn inhibitors approved or in development, spanning different modalities and dosing frequencies, but each comes with trade-offs. Some therapies are dosed cyclically, which results in unpredictable treatment schedules for patients. Others require lengthy IV infusions or frequent dosing.
We believe there is a significant opportunity for a next-generation FcRn inhibitor like VRDN-008 that brings together the attributes that matter the most to patients: deep IgG reduction, sustained disease response, predictable and infrequent dosing, with easy subcutaneous self-administration, all of which are potentially enabled by what we believe to be the unique and exceptional PK/PD profile of VRDN-008. We have shown you our robust PK/PD profile and infrequent dosing schedule for VRDN-008.
Now let us talk about how we plan to deliver it simply and subcutaneously. We are excited to announce that we are moving into pivotal development for VRDN-008 using the enFuse device, which uniquely provides a simple approach to every eight-week subcutaneous dosing. This is a next-generation device on the left of the page here. It is small, lightweight, and hands-free, designed for easy and discreet at-home self-administration with a single push of a button.
Importantly, enFuse is commercially validated and in use with multiple marketed products and in development with several others, including OCREVUS, a blockbuster market leader in MS. On the right, we have shown the large-volume auto-injector that is currently in development for VYVGART HYTRULO. For patients, we believe the choice would be clear. Compared to the large once-weekly auto-injector, we believe VRDN- 008 administered every eight weeks with enFuse offers a superior patient experience.
And we are in a great position, as we have held exclusive global rights to enFuse for FcRn-targeted therapies since January 2023. We believe VRDN- 008 has the potential to fundamentally change what patients can expect from an FcRn inhibitor. As you can see on the slide, current commercially available options and those in development consist of IV infusions or weekly injections, which can be a significant treatment burden. With VRDN- 008, every eight-week dosing would translate to just seven simple subcu doses per year.
This would greatly simplify and improve the treatment experience for patients compared to all of these other options, either commercially available or in development. As Radhika mentioned, we plan to initiate a registrational trial with VRDN- 008 in MG in mid-2027. MG is a large and growing market, with FcRn inhibitors on track to generate over $7 billion in revenues this year, having grown 40% in the last 12 months, and projected to reach nearly $12 billion by 2030.
We believe VRDN- 008 has a highly differentiated profile with the potential to be the treatment of choice for MG patients, and we are excited to start our registrational study next year. MG is only the beginning. We believe VRDN- 008 can also be transformative across a broad range of autoantibody-mediated autoimmune diseases, including those that are already clinically validated for FcRn inhibitors. Consistent with our approach to date, we plan to move quickly while being thoughtful about where we deploy our capital.
What we like about VRDN- 008 is that we have multiple options of de-risked, clinically validated indications to consider today, and we would expect additional indications to enter the funnel as clinical development for FcRn inhibition continues to mature. I will now turn it over to Steve.
Thank you, Shan. The profile for VRDN- 008 that we have shared today is about as clear as it gets. This marks the beginning of a new era for Viridian. We are already building a leading portfolio in thyroid autoimmunity with Lumvoa, elegrobart, and our TSHR candidate, VRDN-292. With VRDN- 008 as a potential best-in-class FcRn inhibitor, we have the opportunity to build on that foundation and expand our impact across a broader set of autoimmune diseases.
As a revenue-generating company, we are entering our next phase of growth from a position of strength, ready to support this next chapter at Viridian. In the context of our story, the potential for VRDN- 008 is bigger than a single asset or a single indication. It represents an additional franchise opportunity for Viridian, reinforcing our vision to become a commercial-stage, multi-product, fully integrated next-generation biotech company.
We are incredibly excited about where Viridian is today, but even more excited about where we can go from here and the impact we can deliver for patients. Thank you for your time today, and we will now open it up for questions.
We will now begin the question-and-answer session. Please limit yourself to one question. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Faisal Khurshid with Jefferies. Your line is open. Please go ahead.
Hey. Good morning, guys. Thank you for taking the question. I just want to ask, based on your understanding of the market and any market research you've done as you've worked on how to optimize the FcRn profile here, how do you think patients and physicians will think about a potential every-eight-week on-body device compared to a market where there might be a weekly auto-injector option available? Thank you.
Thanks, Faisal. Yeah, it's a good question. Obviously, let's just start with the profile in general. A half-life extended ability to deliver the drug, deep sustained IgG reduction during that course of dosing, every-eight-week dosing, as we mentioned on the call. Then to do that with the device, we're really excited about it. It's very simple, hands-free, elegant, lightweight. It's got a lot of really positive attributes that we think are going to translate into a really good patient experience.
Don't forget that this is a marketed product. It has multiple marketing approvals, and it's also in development at Roche with OCREVUS. Because in all those cases, it can be very helpful to the patient experience. So, we look forward to that. We've done market research on the device, to your question. We've done market research on dosing intervals, and the feedback has been very positive. We think the overall profile and the simplicity of this delivery system, we think is going to translate well.
And it is important to just note that with every eight-week dosing, what this means is only seven subcu doses per year for patients. You compare that to weekly injections, that is a really big game-changer, we believe, for patients.
Great. Thank you.
Your next question comes from the line of Alex Thompson with Stifel. Your line is open. Please go ahead.
Hey, great. Congrats for the update, and thanks for taking our question. I guess conceptually, VRDN-008 is similar in design to ARGX-213. Can you talk a little about some of the structural differences there and sort of your confidence and freedom to operate? And then maybe a follow-up question to confirm the MG registrational study, would that be also with the 3,000 mg dose? Thank you.
Yeah. Thanks for the question, Alex Thompson. We feel very confident in our ability with freedom to operate here from an IP standpoint. You will remember that VRDN- 008 was the result of a discovery partnership we did with Paragon Therapeutics, and this is licensed from Paragon. Without going into the details, as you can imagine, it is difficult to engineer a half-life extended FcRn, and we did a fair amount, or Paragon did a fair amount of protein engineering that looked at many different approaches that went into ultimately generating VRDN- 008.
So, we were very impressed with the molecule at the time, and obviously leading to the phenomenal data that we presented today. And so, we are happy with the place that we are. On to the second question around the planned registrational trial MG, that is correct. We plan to take the 3,000 mg dose forward into registrational studies.
Your next question comes from the line of Thomas Smith with Leerink Partners. Your line is open. Please go ahead.
Hey, guys. Good morning. Congrats on these data, and thanks for taking the questions. Just on MG, when we are thinking about product profile and trial design, wondering if you could just talk a little bit about expectations. Are you expecting similar or better efficacy relative to VYVGART, or is this primarily extended interval dosing and you think you can win on patient experience and convenience? Thanks so much.
Thanks a lot for the question, Tom. I think that maybe let us start with the profile that we have generated here today. What you saw in the data is the IgG reductions PD response from what we think is a truly unique and distinct PK profile. And that comes back to the half-life extension that we reported, which is 15- 18 days. It is the longest by far of any that we have known. And then when we took that into on the PD side of things with regards to IgG reductions, we saw deep and sustained reductions, but the peak of that was at 74%.
Not to make cross-trial comparisons, because those obviously come with important limitations, when we look at what the clinical experience is with VYVGART throughout their phase III studies and studies that they have run, the IgG reductions are 61%-67% at peak. We are looking at peak of 74%, which was confirmed by modeling. What we are seeing is deep IgG suppressions with every eight-week dosing regimen there as well.
That makes us feel very confident with the Q8 week dosing regimen leading to both deeper IgG suppressions as well as that sustained IgG suppression that is so important for extending the dosing regimen out here for patients. We think that this could have the potential best-in-class profile for MG patients, and that is what makes us excited about moving as quickly as possible into MG.
Your next question comes from the line of Derek Archila with Wells Fargo. Your line is open. Please go ahead.
Hey, good morning, and thanks for taking the questions. Congrats on the data. Just two from us. I guess first off, what are the gating factors to get the MG trial underway by mid-2027? Also, when contemplating the MG trial, will this enroll a broad set of MG patients, not just acetylcholine receptor-positive patients? Thanks.
Hi, Derek. Yes, thank you for the question. We are moving forward as quickly as possible, as we always try to do at Viridian. We did indicate that we would expect to start in mid-2027 with the MG study. Now, we did just get this data, so we do have some work to do to get set up and get going. But we have been doing a lot of work in the background with respect to feasibility assessments and making sure that we understand it.
With respect to patient segmentation, I think you just give us a few minutes to sort through that, and we will have more details to follow. But obviously, what we benefit from is a number of assets or programs that have gone before us. So there is a body of successful MG trials out there. As we design our program, we'll be able to look for ways to make sure we're as efficient as possible. We're on track and really feeling positive about this profile going into MG.
Understood. Thank you.
Your next question comes from the line of Rami Katkhuda with LifeSci Capital. Your line is open. Please go ahead.
Good morning. Congrats on the update, and thanks for taking my questions as well. I guess building off a previous one, do you expect comparable efficacy with Q4 week and Q8 week dosing, or could greater IgG suppression with Q4 week translate into better outcomes? Can you provide additional details on the expected administration time and volume for the 3,000 mg dose using enFuse?
Yeah, thanks for the questions, Rami. Let me take the first one here. What we saw with the modeling is that the Q4 dosing offers deeper IgG reduction. That may lead to better efficacy for a subset of patients, but it's important to remember what the Q8 week dosing achieves more importantly.
What we saw there was, as we mentioned, a peak reduction of 74% in the study and with the modeling, which comfortably is exceeding the peak IgG reductions that we see from VYVGART HYTRULO or IV, both of which we know provide a compelling clinical efficacy. With every eight-week dosing, we think that we can at least match VYVGART IV and HYTRULO in terms of clinical efficacy in MG. The second question was regarding the amount of volume and dose for the enFuse device.
I think, let me just give a little bit of detail on the device itself, because it's pretty cool. What we have here is a next-gen subq administration device. As we mentioned earlier, it is commercially approved with multiple products. This includes Sarclisa from Sanofi, and then just this past September, Roche on their R&D day announced the development of this device with OCREVUS, and specifically to enable at-home self-administration for OCREVUS. It really is a truly next-gen device.
It's small, it's lightweight, as you saw from the slides, really designed for an excellent patient experience because it's easy, hands-free, and of course, self-administered subq. It's a device that allows us to give the unparalleled every eight-week dosing regimen, which would be phenomenal to be able to bring to these patients. With regards to the 3,000 mg dose, our current formulation of VRDN- 008 is 150 mgs per mL. , and we have developed VRDN- 008 to be compatible with the device.
That translates to a dose of 20 mLs, which comfortably fits into the enFuse device. What we have here is a device that is uniquely capable of delivering VRDN-008 every eight weeks, and on average, we would expect that administration to take about 30 minutes or so. As a comparison, you can take a look at the Sarclisa IRAKLIA trial, where the median duration of the administration was approximately 13 minutes for a 10 mL dose, and we will be dosing twice that volume.
I would just add that this is the same drug, same formulation that's going into the phase III study. So we've already done our formulation work into the 150 mgs per mL. We can capture that in the device, and the device will be used in our first registrational study. So we're ready to go. Been working on this for a few years, so that's a good place for us to be as well.
Awesome. Thank you guys, and congrats again.
Your next question comes from the line of Joseph Thome with TD Cowen. Your line is open. Please go ahead.
Hi there. Good morning, and thank you for taking my questions. Congrats on the data. In terms of the next steps for some of these other indications, what's the largest gating factor to moving those forward? Is it funding-related? Is it additional de-risking internally or externally that you're thinking about? Then for the trial itself, can you just talk about your experience with Lumvoa going against an entrenched competitor and rolling a placebo-controlled study? Do you anticipate that will be a challenge given the availability of the drug? Thank you.
Yeah. Thanks, Joe. So with respect to, in terms of what we're going to do with other indications, we certainly saw on the slide that there's a number of options that are, luckily for us, clinically or commercially validated already. So we have several options there, and we'll unveil our plans beyond MG at a later time, certainly. But we are very happy with the options that are available. With respect to what we have indicated is at least one registrational study. We'll start with MG mid-2027.
We have a very strong balance sheet, as you know, and that will be continued to be bolstered by the Lumvoa launch. As you know, we did our first quarter of launch announcement last week, where we already generated $24.7 million in net product revenue. So we are very comfortable funding at least one registrational study in 2027, and that obviously contemplates our currently planned MG trial, and then our other ongoing activities with respect to our TSHR program as well.
And so, that will be on the backs of our current balance sheet plus our projected revenue from both Lumvoa, and we look forward to elegrobart as well, with our BLA being filed in Q1 next year. So we will have more to say on that. On the enrollment side in MG, we also again get to benefit from what we have seen be done in the past. We have done our early feasibility assessments. We have a good plan as to how we will do this. We have a very strong clinical development team, clinical operations team.
As you know, we have proven that we can execute these global trials very rapidly and do them with high quality. So we look forward to that, and we think that there is plenty of opportunity in MG in particular for us to enroll these studies.
Great. Thank you.
Your next question comes from the line of Laura Chico with Wedbush Securities. Your line is open. Please go ahead.
Hey. Good morning, guys. Two quick ones. Could you speak to the timing of the MG-ADL assessment in the pivotal study? I am asking because what we see with VYVGART is perhaps a greater magnitude of reductions and rebounds over the course of treatment. So I am trying to understand with a Q8 week interval how you are thinking about the timing of the endpoint assessment there.
Then just following up on the decision to move straight to pivotals, realize there is an interest in advancing rapidly, but could you just expand further on that decision versus conducting a smaller proof of concept study first? Thank you.
Thanks for the questions, Laura. So on the first one, with regards to the upcoming registrational study, MG, just want to clarify that we are planning to take VRDN-008 forward as a continuously dosed drug, and every eight weeks, continuous dosing with the deep and durable IgG reductions that you saw today in the data as well as being supported by the modeling. We feel really good about that profile there compared to, say, a cyclical way of dosing these patients.
With regards to the endpoints and the study design, give us a minute there. We obviously have taken all of that into consideration as we move forward into that mid-2027 anticipated start of the MG study.
But we just got the data today, so we will want to go through that and also have an interaction with the FDA before we come out and give you the details on study design. Could you repeat that second question, Laura?
Sure. Sorry about that. Yeah, just I am wondering if you could elaborate further on your decision to advance straight to pivotals versus conducting perhaps a smaller proof of concept study first.
Yeah, thanks for that question as well. Given the validated mechanism for MG and the historical translation from IgG reductions to clinical benefit in MG patients in particular, we have a track record of wanting to move quickly, wanting to move forward with best-in-class profiles as we see it, and be really data-driven in how we approach this.
Given the data that we saw with VRDN-008 today and the potential best-in-class IgG reductions across the board, both deep and durable, we anticipate that to translate well to MG, and it makes sense to not wait for a phase II study and go straight into MG.
Awesome. Thanks, guys.
Your next question comes from the line of Michael Yee with UBS. Your line is open. Please go ahead.
Hey, guys. This is Dina on for Mike. Just one about ARGX-213, which is their fragment as well, and I believe they're trying to do monthly dosing there. Just maybe talk through the differentiations between your asset with VRDN-008 and theirs. I know we're expecting some updates, maybe possibly at JP Morgan, but it sounds like you guys are still ahead and have a more convenient dosing. Just want to run through your thoughts about that. Thanks.
Yeah, thanks for the question, Dina. In fairness, we know very little about ARGX-213. As you mentioned, what we know is they have consistently said they are targeting monthly dosing for ARGX- 213.
They disclosed the model that with the monthly dosing, they expect a 48 mg per kg dose, which, if you do the math there for a 75 kg person, that would translate to a dose of 3,600 mg. That is a large dose as well. Importantly, to really remember that in order to administer that kind of dosing subcutaneously and conveniently, you really need a device like enFuse.
As we said today, we have exclusive global rights to enFuse for FcRn-targeted therapies, and really, there is nothing else commercially available that will allow for administering this large of a dose, let alone provide the superior patient experience that we really think comes with the enFuse device. We feel like we are in a good position with VRDN-008, and obviously have a clear plan for registrational studies to start with MG in mid-2027.
Got it. Thanks.
Your next question comes from the line of Lachlan Hanbury-Brown with William Blair. Your line is open. Please go ahead.
Hey, guys. Thanks for the question, and I'll add my congrats. Maybe building on a prior question, do you have a sense how much a phase III program in MG will cost? Maybe you sort of touched on the fact that there are multiple validated indications, so how many of them could you potentially pursue with the current balance sheet and expected revenues?
Yeah, thanks, Lachlan. I gave part of this answer in one of the last questions. We are very comfortable funding at least one registration trial here. As we indicated, we'll start with MG. We are comfortable funding at least one in 2027. That all includes the other programs that we have, TSHR, as I mentioned, and the continued launch of Lumvoa, and then introducing elegrobart. So we have those projected revenue. We have a very strong balance sheet, as you know.
So when we think about the trial costs, we have ideas. We certainly haven't come out and pinpointed that. We are still, with this data's new coming in, but we have our general plans for going forward. So we feel very comfortable with our ability to fund at least one registration trial coming up.
Your next question comes from the line of Gregory Renza with Truist Securities. Your line is open. Please go ahead.
Hey, team. It's Nikhanj for Greg. Congrats on the data and for taking our questions. Maybe if you could help lay out the economics with Paragon for this program, and separately, any economics you want to highlight with Enable Injections for the enFuse device. Thanks so much.
Yeah. Thanks so much for the question. As you remember, we licensed this from Paragon Therapeutics and have the exclusive license with Enable for the enFuse device, and both of which has been collaborations that we have for some time. The details of these agreements are filed in our 10-K, and so you can take a look at that. But in general, we're talking about small milestones that lead up to development, commercial, with royalties in the single digits.
Thank you.
Your next question comes from the line of Richard Law with Goldman Sachs. Your line is open. Please go ahead
Hi, this is Jane Alfred. Thank you for taking my questions. My first question is, will you continue to develop the VRDN-006 and VRDN-008 in parallel? What is the overall strategy for both going forward? My second question is, what is the injection time for the enFuse device, and will this device be used in the pivotal study?
Hi. Yeah, thanks. With respect to the question on VRDN-006, I think given the profile that we saw today with VRDN- 008, we're going to make sure that we prioritize VRDN-008. So we're starting that prioritization now.
With respect to the second question, the formulation here, the current formulation translates to about a 20 mL dose, which we think on average would take about 30 minutes to inject.
30 minutes to inject?
Correct. Remember that this has been commercially validated for both Sarclisa and other drugs as well. If you take a look at the Sarclisa example, as I mentioned earlier on the Q&A, the median time to injection for them is 13 minutes for a 10 mL volume, and we plan to be injecting twice that volume.
I think the key to remember there is, this is every eight weeks. It is a total of seven administrations per year. That is a pretty important distinction with respect to the rest of the landscape.
Your next question comes from the line of Serge Belanger with Needham. Your line is open. Please go ahead.
Hi. Good morning. This is John on for Serge today. Congrats on all the progress. Just one from us regarding safety. Curious what, or if any, potential safety risks you identified in the healthies in phase I. Moving into the phase III, curious where some of your key areas of focus will be on the safety front, considering VRDN-008's product profile that you have seen to date, and how that may differentiate versus currently approved products. Thanks.
Hi. Thanks for the question. If you take a moment and you look at safety overall, what you really see is actually not too much. Nearly all the events were grade 1, and the kind of events that you would expect to find in a phase I healthy volunteer and ultimately balance between arms. There was one patient that had an isolated grade 3 CPK and an AST elevation in a low-dose SAD cohort, but that was deemed unrelated in a subject who was actually involved in bodybuilding.
Beyond that, we had one grade 1 headache, two cases of grade 1 headache that were deemed unrelated in the lowest dose in the SAD cohort. That is a total of two out of 64. That is a very clean safety profile. I think, as expected, there is a standard expectation of what FcRn inhibitors could do. We would be looking for that in a standard approach in our phase III study.
We have reached the end of the Q&A session. I will now turn the call back to Steve Mahoney for closing remarks.
Thank you all for your questions today. We are really excited, as you can tell by the VRDN-008 data. We are focused on executing, as always, and we are excited about the next phase of Viridian's growth. We look forward to continuing to update you on our progress.
This concludes today's call. Thank you for attending. You may now disconnect.