Good morning, welcome to the Selecta conference call on the top line results from DISSOLVE I and II, the Phase 3 trials of SEL-212 in chronic refractory gout. All participants have been placed in a listen-only mode. After prepared remarks, we will conduct a question and answer session. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. For opening remarks, I would like to introduce Blaine Davis, Chief Financial Officer of Selecta. Please go ahead, sir.
Thanks, operator. Good morning, and welcome to today's call, where we will share with you the exciting top-line results from DISSOLVE I and II, the Phase 3 trials of SEL-212 in chronic refractory gout. The press release announcing these top line results is available in the investor section of Selecta's website at www.selectabio.com, and today's presentation has been posted there for your review. Joining me on today's call are Carsten Brunn, President and Chief Executive Officer; Peter Traber, our Chief Medical Officer; and Kei Kishimoto, Chief Scientific Officer. Before Carsten and Peter welcome you and discuss the results, I'd like to remind you that we'll be making certain forward-looking statements, including statements about the potential safety, efficacy, and regulatory and clinical progress of our pipeline candidates, our financial projections and our future expectations, plans, partnerships, and prospects.
These statements are subject to various risks that are described in the filings made with the SEC, including our most recent annual report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today, March 21st, 2023. Selecta disclaims any obligation to update such statements except as required by law, even if management's views change. Carsten.
Good morning, everyone, thank you for joining our call today. We are thrilled to announce that both Phase 3 studies of SEL-212 in chronic refractory gout, the U.S. DISSOLVE I study and global DISSOLVE II study, have met the primary endpoint. We're highly encouraged by these results. As you can see on Slide three , the response rate in the high-dose group was 56% in the U.S. study and 47% in the global study. In patients 50 years of age or older, the response rate of the high dose was 65% in the U.S. study and 48% in the global study. We're also very encouraged by the safety profile of SEL-212 observed in the trials. In the U.S. study, 75% of subjects who completed six months of therapy continued to respond through 12 months with no infusion reactions and no new safety signals.
The infusion reaction incidence was 3.4% in the high-dose group, and there was no increase in gout flares in SEL-212 treated groups versus placebo. These exciting top-line data suggest that SEL-212 has the potential to provide a new treatment solution with once-monthly dosing that could have a meaningful impact on the quality of life for patients with chronic refractory gout. Peter.
Slide four shows important facts related to our investigational drug, SEL-212, which is a combination drug product consisting of two components. The first component is pegadricase, which is a potent enzyme that can reduce serum urate in patients with gout that is refractory to standard therapy and who continue to have serious disease symptoms such as debilitating joint pain and disfiguring tissue deposits of urate called tophi. The second component of the drug is ImmTOR, a nanoencapsulated formulation of rapamycin that conditions the immune system to reduce antibody formation to drugs that are given at the same time. The proposed mechanism of ImmTOR action is the induction of immune tolerance rather than immune suppression, as with other commonly used drugs.
The figure on this slide is from our publication of Phase 1 study results and shows that one dose of pegadricase alone has been observed to induce an immune response with anti-drug antibodies which reduce enzyme effectiveness and may lead to adverse events. ImmTOR, given as a single dose before pegadricase, reduced the development of pegadricase antibodies with a greater effect of 0.15 mg/kg dose as compared to the 0.1 mg/kg dose. Based on these findings and Phase 2 data, in which once-monthly dosing for six months was observed to reduce serum urate, the FDA allowed us to take these two doses to be evaluated in Phase 3 clinical trials. Slide five outlines the two trials in the Phase 2 program on which we are reporting top-line data today.
We completed two identically designed randomized double-blind placebo-controlled trials in patients with gout refractory to conventional therapy. Patients were randomized evenly into three treatment arms, placebo and two doses of SEL-212. These were administered as a single treatment every 28 days, which defined the treatment period. In this presentation, we use shorthand for treatment arms. 0.15 SEL-212 or high dose refers to infusion of 0.15 mg/kg ImmTOR followed by IV infusion of 0.2 mg/kg pegadricase. 0.1 SEL-212 or low dose refers to IV infusion of 0.1 mg/kg ImmTOR, followed by IV infusion of 0.2 mg/kg pegadricase. Placebo consisted of two separate doses of saline. All infusions were double-blinded.
The primary efficacy endpoint for both DISSOLVE I, which was enrolled at 29 U.S. sites, and DISSOLVE II, which was enrolled at 37 sites in Europe and the U.S., was assessment of serum urate levels during treatment period six. Responders were defined as those who achieved and maintained serum urate levels less than 6 milligrams per deciliter for at least 80% of the time during treatment period six. This was based on six measurements of serum urate distributed over the treatment period. In DISSOLVE I, subjects continued treatment for an additional six months in a blinded safety extension phase. Slide six depicts the flow of patients in both studies. In the U.S. study or DISSOLVE I, 112 subjects were randomized and dosed. In the global study or DISSOLVE II, 153 subjects were randomized in dose. This represents the intention to treat or ITT data set.
The table on Slide seven describes the baseline demographic information. Subjects were a mean age of approximately 55 years old, with about 70% 50 years old or greater across both studies. The average BMI was in the obese range, and over 95% of participants were male in both studies. In the U.S. study, 31% of subjects were non-white, while the percentage of non-white subjects was 11% in the global study. In the global study, 15% of enrolled subjects were from Russia and Ukraine, countries affected by war during the study. The numbers in each demographic category were reasonably well-balanced across treatment groups and represent what is seen in real-world prevalence. Baseline disease characteristics are shown on Slide eight , which were also well-balanced across treatment groups. Several parameters suggest that the severity of gout was somewhat greater in the global study.
This is based on a higher percentage of patients with tophi and a larger average number of tender and swollen joints. However, the serum urate levels were similar between the studies. Slide nine shows the critical primary endpoint data for the ITT data set. Both studies met their primary endpoint with a statistically significantly greater responder rate in both the low and high dose treatment groups versus placebo. The high dose group had 56% responders in the U.S. study and 47% responders in the global study. The low dose group had somewhat lower response rates of 48% and 41% in the two studies. We believe this may indicate a dose response relationship for clinical activity.
The primary endpoint analysis was done on multiple population sets to assess the stability of the responder rate, including removal of those discontinuing therapy due to COVID-19, removing subjects in Russia and Ukraine, and removing those with a major protocol deviation that may affect the primary endpoint. The re-responder rates were consistent across these multiple modified ITT and per protocol population groups. Meeting the primary endpoint for both dosing groups versus placebo was the key objective for success of these Phase 3 studies intended for registration. Slide 10 represents the primary endpoint measurement for the subgroup of patients who were 50 years of age or older, which includes approximately 70% of subjects in the two studies. This subgroup analysis was predefined in the statistical analysis plan.
The high dose group had 65% responders in the U.S. study and 48% responders in the global study. Similar to the ITT group, the low-dose group had lower response rates. Slide 11 reports data on the two key secondary endpoints that we have analyzed at this time. Others are not yet available. This table shows that the mean and % change in serum urate from baseline to treatment period six. The mean and % reduction of serum urate in both studies for both low and high-dose groups were robust as compared to placebo and highly statistically significant. To assess safety signals, the adverse events, or AEs, were pooled for the two studies through the six-month primary endpoint. The table on Slide 12 lists all adverse events of special interest, or AESIs, which were included in the protocol as agreed with the FDA.
Beyond these AESIs, there were no other treatment-emergent AEs observed in at least 5% of the subjects. We view the number of subjects with gout flares as a favorable finding as there was no difference in gout flares when both treatment groups were compared to placebo. This is an encouraging finding since other therapies that markedly reduce serum urate have been shown to precipitate an increase in gout flares. The other AESIs that occurred in greater frequency in treated groups versus placebo were expected and generally encouraging. There was a greater number of infusion reactions at 24 hours and 1 hour after drug administration in both treatment groups versus placebo. Because of the importance of infusion reactions, these will be described in more depth in a subsequent slide. There was also a difference in AE frequency from placebo in stomatitis, which included oral and aphthous ulcers.
Stomatitis was seen in 3.4% of the low-dose group and 9.2% of the high-dose group. Since this AE is known to be related to rapamycin, a dose relationship was expected. All the cases of stomatitis were either mild in 69% of the cases or moderate in 31% of the cases. Serious adverse events are listed on Slide 13. SAEs related to treatment were seen in six subjects, three in the low-dose group and three in the high-dose group, or 3.4% in each. These treatment-related SAEs included two cases of anaphylaxis and one gout flare in both the high and low-dose groups. Excluding anaphylaxis and gout flare, there were more SAEs in the low-dose group versus placebo, 10 versus two, but a similar number of SAEs in the high-dose and placebo groups, three versus two.
We don't believe there was any dose response or obvious pattern of etiology to suggest causality for these non-treatment related SAEs. Slide 14 visually depicts the occurrence of infusion reaction over the duration of the studies. The incidence of infusion reactions within one hour of administration is an important aspect of drug safety when delivering an antigenic protein such as pegadricase. The incidence of infusion reactions over 12 months of the pooled studies, including the six-month extension for the U.S. study, was 3.4% for the high-dose group and 4.5% for the low-dose group. This compares favorably to other protein therapies for gout. The infusion reactions occurred early in the study, with all the reactions taking place during one of the first three doses of the drug.
Finally, importantly, all infusion reactions occurred during drug infusion, and symptoms completely resolved with stopping the infusion and symptomatic treatment with fluids, antihistamines, and/or steroids. In the U.S. study extension phase, 75% of those subjects who entered the six-month extension phase on active drug treatment were responders with mean serum urate levels below 6 milligrams per deciliter in treatment period 12. Additionally, during the extension treatment period, there were no infusion reactions, no new AESIs, nor additional safety signals identified. There were nine SAE events in seven subjects, but none were identified as related to the study drug. In conclusion, on Slide 16, we are very pleased to report that both the U.S. and global Phase 3 studies met the primary efficacy endpoints with a statistically significant response rate of both high dose and low dose SEL-212 versus placebo.
The response rate in the high dose group was 56% in the U.S. study and 47% in the global study. The response rate in the high dose group for patients 50 years of age or older was 65% in the U.S. study and 48% in the global study. 75% of subjects who entered the six-month extension phase on active treatment were responders at 12 months with no new safety signals. Importantly, the infusion reaction incidence was 3.4% in the high dose group. Finally, there was no increase in gout flares in the SEL-212 treated groups versus placebo.
It is our belief that the top line efficacy and safety data from these two Phase 3 trials suggest the potential for SEL-212 to provide a new treatment solution with once monthly dosing in patients with chronic refractory gout. Slide 17 is an important acknowledgement. Conducting and completing Phase 3 clinical trials requires a massive team effort. I thank the entire extended team who worked on these two trials. First and foremost, a huge thank you to the participating patients and families and the clinical trial sites and staff. Thanks to the Selecta clinical team and the entire company for all their work in bringing this program through Phase 3. I also thank Sobi, our partner in this important development program, and Parexel, who has been our CRO partner throughout the planning, conduct and analysis of the trials. Carsten.
It is very gratifying and reaffirming to see the potential impact our technology has on patients' lives. The positive readout of the DISSOLVE program is a pivotal milestone for Selecta and for the many patients suffering from chronic refractory gout. We believe the data from DISSOLVE I and II positions ImmTOR as the only immune tolerance platform with positive Phase 3 data. We believe SEL-212 is now well positioned to move forward towards regulatory submission and potential commercialization in the U.S., which is being managed by Sobi and is anticipated in the first half of 2024. As a reminder, Selecta is eligible to receive up to an additional $65 million in development and regulatory milestones, up to $550 million in commercial milestones, as well as tier double-digit royalties on net sales.
To reiterate, we are very excited to have successfully completed the DISSOLVE program and thrilled with the potential of this new treatment option to improve the lives of patients with chronic refractory gout. More broadly, with over 400 patients dosed to date, we plan to continue to leverage our growing safety database to accelerate our clinical pipeline powered by our ImmTOR technology in combination with IL-2 for patients suffering from autoimmune diseases. I'd like to sincerely echo Peter comments and thank the many people who have been integral in moving SEL-212 forward for clinical development, including our patients and their families, our investigators who spearheaded the DISSOLVE program, our participating trial sites, and our partner, Sobi. Lastly, I'd like to thank the entire Selecta team who have worked tirelessly to bring SEL-212 to where it is today.
Operator, we can now open the line for Q&A.
Thank you. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. In the interest of time, we ask that you each keep to one question and one follow-up. Our first question comes from the line of Joe Schwartz with SVB Securities. Please proceed with your question.
Hi, this is Beth on for Joe. Thanks for taking our question, and congrats on the exciting data. I noticed that the DISSOLVE I U.S. study generally seemed to show a higher response rate versus DISSOLVE II. I was just curious if there are any sort of baseline characteristics or other sort of external factors that may have explained this. I have a follow-up.
Yeah. Thanks, Beth. We are very excited indeed. I'll let Peter talk about the baseline characteristics which were in line, you know, largely balanced, but I'll let Peter provide more color here.
Yes. The, you know, it's very common, to have, different, response rates in different Phase 3 trials. You know, sometimes it's in one region versus another. You can't always determine, you know, what the underlying reasons are, and I think that other competitors have had, you know, different results when two Phase 3 studies are done. Now, having said that.
The patients in the global study were slightly more severe by a couple of criteria, number of tophi and number of swollen and tender joints. However, the serum urate levels were pretty similar. We will get a better understanding of some of the severity issues and the response issues when we are able to evaluate the data on other secondary endpoints, which we have not done yet, such as patient-reported outcomes and so forth. I don't think that we have an explanation for that difference, but it is common to see a difference between Phase 3 studies.
Got it. That makes sense. My second question, I was just curious what work still needs to be done to support the U.S. regulatory submission in the first half of next year?
Yeah, that's a great question. Obviously, we've conducted the DISSOLVE program on behalf of Sobi. Moving forward, Sobi will be responsible for the BLA filing, and they'll provide additional details on what still needs to be done. We feel very confident on all the things that are going on right now to meet a submission in the first half of next year.
Great. Thank you.
Thank you. Our next question comes from line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.
Hi. Good morning, everybody. Congrats on these very important data for the platform. The first question, I understand that a majority of patients are over the age of 50, but can you help us understand how they're currently responding to standard of care outside of just on efficacy measures, but how should we think about safety and tolerability? For example, what are the key reasons perhaps why they may not stay on KRYSTEXXA and methotrexate?
Yeah, Kristen, that's a great question. We are indeed thrilled by this group over 50, which is very meaningful to majority of patients in clinical practice, where we saw a response rate of actually 65% at the high dose in DISSOLVE I and 48% in DISSOLVE II. I'd like Peter provide a couple more points just from a clinical perspective what is important to consider here.
Yeah, it's an insightful thought, Kristen. I think that, you know, as you, first of all, not only are the majority of patients over 50 with chronic refractory gout, but as you get over 50 and get older, you start to accumulate a lot of additional concomitant medical problems and are often on many other medications. These include hypertension and diabetes, which can, of course, affect kidney function, obesity, and cardiovascular disease. As you have these comorbidities and increasing age, the any medications added to your regimen can be a problem. Certain medications, you mentioned methotrexate there, that medication can be a problem with reduced renal function.
It's known that there's an increase in GI disturbances with methotrexate over in older patients. I think in general, the incidence of problems with additional medications goes up in the larger age group. Our therapy, which is once monthly dosing, and we didn't see a difference in the adverse effects in the different age groups, that I think bodes very well for being able to use it in that older age group.
Got it. Thank you. Just as a follow-up, if you could share which endpoints you might include at the upcoming medical conference? Thanks again, congratulations.
Over the next, First of all, we haven't, you know, defined the medical conference that we'll re-report at as yet. That'll be an agreement between us and Sobi that we will announce. Secondly, we will be working over the next months to look at all the secondary endpoints, and there are quite a few. I don't know that I should list them here, there are patient-reported outcomes and % gout flares and incidents of gout flares in different periods of time, effect on tophi. All of that will be analyzed over the next couple of months and will be included in the scientific communication at a meeting and/or publication.
Thank you.
Thank you. Our next question comes from line of John Newman with Canaccord Genuity. Please proceed with your question.
Hi, guys. Good morning. Just wanna say congratulations on a well-executed study. Certainly no small feat in the age of COVID-19, especially in Eastern Europe. Congratulations on that. Just have one or two questions. You know, obviously you tested a high and low dose in these studies. Just curious if you can give us any sense as to whether you'll be filing both of those doses for FDA approval or whether there might be one dose or the other that you're thinking about there. Thanks.
Yeah, that's an important question, John. Obviously, we're very pleased that both doses met the primary endpoint are statistically significant. We will discuss with Sobi and ultimately with the FDA, which dose will be brought forward into the filing.
I would just add to that. What Carsten mentioned this on the call, but the fact that there was a dose response is a very good sign for the activity of ImmTOR in this drug combination. I think that that does play into approval status as well and what decisions might be made about which dose to register.
Great. Just one additional quick question. I don't know if you've looked at this yet, but wondering if you can give us any color on efficacy for SEL-212 and ImmTOR in patients with tophi?
Yeah. At this point, John, we haven't analyzed those data. Those are in the next set of tables and so forth that we will get. We basically focused on the endpoints related to serum urate in this top line because of the primary endpoint and top 2 key secondary endpoints as well as safety. That will be analyzed in the near future.
Okay, great.
Just to add, Peter, we actually 70% of patients had tophi in the program across both groups.
Very good. Thank you.
Thank you. Our next question comes from the line of Yun Zhong with BTIG. Please proceed with your question.
Hi. Good morning, thank you very much for taking the question, and congratulations on the positive data. A follow-up question on the dose of ImmTOR. Assume that you've registered both doses. In real world, do you think there are patients that might be more suited for the low dose?
Yeah. I think that's an important issue to consider as we, as Sobi primarily determines what doses they want to apply for in the BLA. At this point, Yun, we don't really have any indication to focus on one or the other than the efficacy difference and the safety difference that we have seen in between the two doses, which might not be highly significant, but certainly is an issue to consider. I think that our view is that the high dose 0.15 was safe with minimal SAEs and was more efficacious, and that might be the direction to go.
Having said that, I think it's much more straightforward and convenient to think about a single dose rather than two doses and how do you choose them, unless you have a very clear understanding of how you're gonna choose between the two doses if both are on the market. Those are my thoughts on it, but I think that Sobi will have to make a decision about how to proceed with that.
Okay. On the efficacy and safety differences between the doses, I know that the infusion reaction rate is overall very low, but did you see a correlation between infusion reaction and the lack of response in the studies?
Some of that analysis, which is a really important question, need to wait for secondary endpoints analyzing anti-pegadricase antibodies and anti-uricase antibodies and the correlation between infusion reactions and efficacy and the development of antibodies. I don't have a clear view on that at this point. What I can say is there is the reduced infusion reaction rate at the higher dose, and there's also a reduced stopping rule which data was not shown there, but an increased stopping rule in the low dose. The other. I think that the fact. I would leave it at that in terms of how they might, how one might choose between the two doses.
There's no clear issue, but I think it all points to the high dose of being the primary dose.
Okay. Okay, great. Thank you very much for the information.
Thank you. Our next question comes from line of Gil Blum with Needham & Company. Please proceed with your question.
Hey, good morning, everyone, let me allow to add my own congratulations on the completion of this program. Just a couple from us. Any thinking about the size of the placebo effect in the global study? I find it slightly surprising that there would be more of an effect ex- U.S. in the control arm, but any color there?
Yeah, it's a good observation. At this point, I don't think we have a clear view of that other than randomness. In the U.S. study, there was one subject that had a placebo response, and that was basically because they started at a just eligible level of serum urate, and they drifted down over the six-month period and ended up below six. You know, this happens in studies where people make lifestyle changes, go on diets, lose weight, etc. That's explainable and why we had up to 5% allowance for a placebo response. In the global study, we had a few more of those that occurred.
I don't know that it's anything other than random at this point, but we'll be investigating each of those subjects in each site more carefully. I would mention that in other trials, the level of urate for enrollmen itt was eight. In our trial, it was seven. There would be a few more patients that are in near seven, which could allow them to drift into the range of response. Now, when you look at those patients, we're talking about, you know, serum urates of 5.8 versus less than 0.2. There's a huge difference between the placebo patients and the treated patients. They did reach the response rate as defined-
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Thank you. Sorry. Our next question comes from the line of Boobalan Pachaiyappan with H.C. Wainwright. Please proceed with your question.
Hi. Thanks for taking our questions. Congrats on the positive data. One thing that caught my attention was the exceedingly high screening failure rate. Do you have any thoughts on that?
I don't have any specifics on the all the reasons or that for screening failure. I will say that many organizations now use social media recruiting for the initial phase of getting subjects to come into the clinical trials. Generally speaking, those subjects have a higher screening fail rate because they're, you know, responding to social media ads versus their physicians referring them for the trial. I don't have any specifics to tell you why it was the rate it was, nor any comparisons to other studies to know whether it's actually very high or not.
All right. Thanks for the color. Maybe this is for Carsten. Carsten, I understand Sobi is responsible for commercialization of SEL-212. just like to get your personal thoughts on market conditioning that needs to be done for SEL-212 U.S. penetration. as you probably, as you know, KRYSTEXXA actually have less than 10% market share despite receiving the U.S. approval in 2010, which means a significant portion or significant market is still untapped. At the same time, that also comes with the risk of, you know, further or additional market conditioning. maybe I would like to hear your personal thoughts on that.
Yeah. As you rightly said, it's really an important question. Sobi's responsible, sole responsible for commercialization. Obviously I have a personal view on this, you know, having a commercial background. I think it's a great time actually to launch into this market. There is, you know, an established treatment network of infusion centers in place. There is, you know, pretty good awareness around the disease with both patients and physicians. At the same time, pretty low penetration, which, you know, I think has to do with the profile. I think with SEL-212, we have a very competitive profile actually.
You know, and I'm sure, and I don't wanna speak for Sobi, but they obviously will take advantage of the time with this very strong data set and prepare the market for a successful launch.
Thanks so much. Congrats again.
Thank you. Our next question comes from the line of Uy Ear with Mizuho. Please proceed with your question.
Hey, guys. Yeah, congratulations on the data. Just curious, Carsten Brunn, how do you think this profile, I guess, stacks up against the competitor and how do you see it differentiated? Just wanna get a better sense of, again, on the commercialization, how it could just differentiate from the competitor. Thanks.
Yeah, I love the question, Uy. I think it's a softball. Obviously, I think the efficacy, we're very pleased with the efficacy. We think that's very competitive, you know, especially looking at the high dose. You're looking at, you know, 56%, 47%. If you look at the subgroup of patients, which the majority in clinical reality over 50 is, you know, 65%, and 48%. I think that's very competitive. I think we're also quite pleased with the favorable safety profile we see as well. You know, 3.4% infusion reaction in the high dose. They all happened in the first three months. We're extremely pleased that there's no increase in gout flares versus placebo.
That's really, in clinical practice, a real issue if you speak to a rheumatologist. Lastly, we're also pleased with the six-month extension, where we saw majority responders, that made it into the six-month extension, were responders at month 12, with no infusion reactions and no new safety signals. Of course it's a monthly dosing regimen as well. I think all those put together make this a very competitive profile.
Okay. My follow-up question is, I guess on the stomatitis, is that consistent with what you've seen previously or lower than what was previously seen? I know it's mild to moderate. Just curious whether that was a nuisance to patients?
Yeah, it's an important issue because it really is the only adverse effect that we identified as being greater than placebo with the treatment, and it is related to ImmTOR. It's lower. The rate we saw is a bit lower than we saw in the COMPARE trial, where it was about 11% incidence of stomatitis. Here at the high dose, we saw 9% incidence. The stomatitis generally occurred after the first infusion, at about 14 days, and its average duration was about 10-14 days. Mild to moderate. Didn't even require any treatment. It didn't stop anybody from taking the drug.
If you get an adverse event after the first dose of something and it's bothersome to you're not likely to come back. Well, nobody stopped because of the mild stomatitis. That's the additional color I can give you on that.
Okay. Helpful. Thank you.
Thank you. Our final question this morning comes from the line of Gil Blum with Needham & Company. Please proceed with your question.
Hey, guys. Thanks for putting me back in the queue. I got, I disappeared there for a second. Just a clarification. The 75% of patients that remained on study, are those only out of the responders or is this everyone who stayed on study? Thank you.
Yeah, Gil. Important observation and question there. The way we defined that was everybody who entered into TP7 with a dose of active drug. They would have been responders through the first six months. They were already The question we were trying to address was, for those that are responders, how many will continue to respond? Over the course of the next 12 months, excuse me, next six months out to the month 12, 75% of them overall continued to respond. But as, but in TP12, if they got a TP12 dose, 100% of those people responded. The people that dropped out over the second six-month period were for a variety of reasons. As you see in the SAEs there, one died in a motor vehicle accident.
There were other SAEs that had them withdrawn. It wasn't because the drug stopped working generally. That they had infusion reactions. There were other reasons why they dropped out. We were very encouraged by that because it means if you get to through six months of therapy, you're very likely to be able to continue for another six months of therapy and get the benefit of the drug.
Thank you again for taking our questions. Very helpful.
All right. Thanks.
Thank you. Ladies and gentlemen, that concludes our time allowed for questions. I'll turn the floor back to Dr. Brunn for any final comments.
Thanks again for joining us for this exciting data release this morning. Stay safe and healthy, and this concludes today's call.
Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.