Q3 2021 Otonomy Inc Earnings Call
Yes.
Good day, everyone and thank you for standing by and welcome to the autonomy third quarter 2021 financial results and corporate update call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star.
And the number one on your telephone and if you require any further assistance. Please press star Zero I would now like to hand, the conference over to your speaker today.
So simona the Vice President Investor Relations at the rest of the week. Please go ahead.
Good afternoon, and welcome to autonomy third quarter 2021 financial results and business update conference call. Joining me on the call from autonomy are Dr. David Weber, President and Chief Executive Officer, and Paul Cayer, Chief financial and business Officer.
Before I turn the call over to Dr. Weber I would like to remind you that Steve call will include forward looking statements based on current expectations such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results.
Please refer to autonomy filings with the SEC, which are available from the SEC or on the autonomy website for information concerning the risk factors that could affect the company autonomy, specifically disclaims any obligation to update any forward looking statements, except as required by law.
I will now turn the call over to Dave Weber, President and CEO of autonomy.
Thank you Contessa.
Good afternoon, everyone and thank you for joining us on this call to discuss Autonomies recent business updates as well as our financial results for the third quarter of 2021.
We have continued the strong momentum in our ongoing clinical trials and the key takeaways for this quarter's update are as follows.
Enrollment for the OTO 313 phase II trial in Tinnitus is on track and we are reiterating our guidance for top line results in mid 2022.
We are actually ahead of schedule for enrolling the OTO 413 phase Iia cohort in hearing loss and now expect top line results early in the second quarter of 2022.
Additionally for OTO 413, I am pleased to report that we have completed the necessary activities to support clinical evaluation of higher dosing and expect to initiate enrollment in the next month.
I'll discuss this more in a minute, but our overall plan is to complete the phase Iia cohort and higher dose safety testing in order to initiate a full dose ranging phase II efficacy trial for OTO 413 in hearing loss patients by the end of 2022.
Regarding our auto 825 gene therapy program.
IND, enabling activities are ongoing and we still expect to file an IND in the first half of 'twenty 'twenty three.
We're also continuing to progress our two other preclinical programs OTO 510 for OTO protection and <unk> six X X for severe hearing loss.
Finally, we are on track with our financial guidance for 2021 and expect that our current cash will fund the company into the second half of 'twenty 'twenty three.
During this call I'll provide a brief update on our programs and financial results and then we can open up the line for questions.
Beginning with OTO 313 enrolment in the phase II trial is going well.
The design of this trial is based on the successful phase one two trial that demonstrated a higher proportion of responders in the OTO 313 group versus placebo based on the tinnitus functional index or <unk>.
The phase II trial will enroll approximately 140 patients with persistent unilateral tinnitus or at least moderate severity based on the <unk>.
Patients are randomized to a single entered tympanic injection of OTO 313, or placebo and followed for four months.
As in the phase one two trial, we will use the <unk> response at both month, one and month two for primary efficacy.
Based on the phase one two trial, we have enriched the study population by increasing the minimum <unk> score required for entry and excluding patients with severe or profound hearing loss.
We also expanded the patient population eligible by increasing the maximum time from tinnitus onset from six months to up to one year.
The trial is enrolling across U S and Europe and enrollment is on track for top line results in mid 2022.
We also recently announced publication of the OTO 313 phase one two trial results in otology and neuro Otology, a leading peer reviewed journal in the otolaryngology feel.
While we have previously disclosed the material results in our public communications complicate. The publication includes additional supportive detail for.
For example data for the eight subscales of the Tsi are presented in radar plots demonstrating clear separation in the change from baseline to month, two for OTO 313 versus placebo.
This improvement is easy to visualize for multiple sub scales, including auditory function and truthiness sleep disturbance cognitive interference sense of control emotional status and quality of life. The.
The broad based improvement reported by patients highlights the potential treatment benefit of <unk>.
$3 13.
Our next clinical stage program is OTO 413, a sustained exposure formulation of brain derived neurotrophic factor or bdnf, which is an endogenous nerve growth factor there.
This therapy therapeutic approach is highly relevant for the treatment of a broad hearing loss population based on the growing body of evidence, indicating that damage to neuronal connections in the cochlea due to aging or noise occurs earlier than hair cell loss.
Up to the inner ear can induce neurite sprouting and promote the reconnection of auditory nerve fibers to hair cells.
By repairing these cochlear synapses, we believe that OTO 413 can improve functional hearing which has demonstrated using speech in noise hearing tests.
Yes.
Following the positive ascending dose phase one two trial, we initiated an expansion cohort for the highest dose evaluated this phase Iia cohort is a randomized double blind placebo controlled study that is expected to complete enrollment of approximately 30 hearing loss patients in the next few.
Weeks 20 patients will receive a single inter tympanic injection of <unk> three milligrams, OTO 413, and 10 will receive placebo patient.
Patients will be followed for three months and evaluated.
Two validated speech in noise hearing test used in the prior cohorts.
The American English matrix Sprague's test the words, the noise test and the digits and noise test.
Enrollment of the Phase Iia is ahead of schedule and we now expect top line results early in the second quarter of 2022.
Because all OTO 413 doses tested in the initial cohort were well tolerated we have been working in parallel with the phase Iia enrollment to enable evaluation of higher dosing as a developer I always want to push to the highest safe dose and I'm pleased that we completed the necessary activities.
Including sharing of information with the FDA. So that we can initiate enrollment of a higher dose cohort in the next month.
We will enroll up to 12 hearing loss patients randomized two to one to OTO 413, or placebo and at least one higher dose safety cohort.
Then based on results from the phase Iia cohort and higher dose safety evaluation, we will initiate a full dose ranging phase II efficacy trial in hearing loss patients by the end of 2022. This.
This program continues to move along well with the potential to address a multibillion dollar market opportunity.
Our third program is <unk> <unk> five a gene therapy targeting <unk>, two which is the most common cause of congenital hearing loss.
<unk> born with this mutation can have severe to profound deafness in both ears that is identified in screening tests now performed routinely in newborns.
Preclinical proof of concept results for OTO, a two five demonstrate that a single administration of OTO 825 rescue hearing loss and coakley or damage in two preclinical models, representing a range of here.
Severity by G JV to deficiency.
We have completed a pre IND meeting with the FDA that provided guidance regarding non clinical study design.
Manufacturing requirements and clinical trial considerations.
And have incorporated this feedback into our IND, enabling program.
These activities are ongoing and we expect to file an IND in the first half of 2023.
Our remaining two programs our <unk> four.
OTO 510, and other protect them for patients at risk for cisplatin induced hearing loss.
Six X X, which targets <unk>.
Hair cell repair our regeneration for patients with severe hearing loss preclinical.
Development continues on both of these programs.
Switching briefly to our financials, we are on track with our guidance for 2021, we reported GAAP operating expenses totaling $12 5 million in the third quarter of 2021, and non-GAAP operating expenses of $10 7 million.
The adjustment for non-GAAP expenses is the exclusion of stock based compensation with the reconciliation provided at the end of today's release.
From a cash perspective, we finished the third quarter with a cash balance, including cash cash equivalents and short term investments of $87 1 million and we continue to expect that this cash balance will fund the company into half of 2023.
In summary, we.
We are making good progress in advancing our multiple clinical programs for treating hearing loss and tentative, which represent large untapped markets with significant unmet medical need.
Patient enrollment in the OTO 313 phase two and OTO 413 phase Iia is going well and we are excited to be able to evaluate higher dosing for OTO 413.
Additionally, we are the first and only company to present preclinical proof of concept results for a gene therapy targeting <unk> two deficiency the largest congenital hearing loss patient population, we have cleared guidance from the FDA on what is required to move this program into clinical development.
And those IND, enabling.
Ongoing.
Our balance sheet is strong and we are fully focused on successfully achieving our program milestones, including the multiple clinical readouts. We have in the next few quarters.
Operator, we are now ready for questions.
Thank you Dr. However, ladies and gentlemen, if you have a question at this time. Please press the star and the number one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Now our first question comes from Ken.
Got your theory of Cowen. Please go ahead Sir.
Hey, guys, how you doing congratulations on all the really good progress.
Dave you gave a good description of tsi.
Just wondering though can you talk about what we should be expecting for clinically meaningful improvement can you help us maybe set a threshold as we kind of a wait those results and then a little bit on the implications of expanding from six months to one year, obviously, it sounds like you want to be able to kind of.
Quicken the pace of enrollment you've got to give a little bit to get a little bit maybe talk about though some of the implications of doing that and then on 400 <unk> three.
Can you talk a little bit about the enrollment criteria, obviously, a lot of heterogeneity in hearing loss, how youre screening for that in and ensuring that we have the kind of the patient population that you would want thanks so much.
Sure Ken Thank you and thank you.
Very delighted with the progress that we continue to make in achieving our clinical milestones.
On a reliable basis, so let's talk about $3 13 first in the tier five so.
<unk> is a clinically validated instrument for measuring tinnitus severity and.
In establishing that clinical validation, what the developers identified as a clinically meaningful level of change is the 13 point or greater change.
And that is what we use for our requirement as the clinically meaningful improvement of the 13 point changed Erik a little background. There that <unk> has eight subscales. There are 25 questions that add up to 100 possible points and so what we're looking for here is the reduction.
And the number in the score and so that 13 point or greater changed now what I will mention also is that we've actually even increased.
Our hurdle, even more and I think this is important most of us are used to clinical trials being based on single endpoint, but we really believe we are changing biology here in terms of reverting the.
Fact of tentative and in doing so what we're looking for is really a prolonged effect and the reason I say that is we actually use multiple time points as you know we use.
Both month, one and month to half to achieve that clinically meaningful level of improvement and that's something we saw in our phase one two trial, where we saw patients improving and achieving clinically meaningful improvements at both month, one and two and so that's really our responder analysis that we will use as our primary.
In the phase two in.
In addition, we will continue to have in that phase II trial, the loudness and annoyance measures, which are done on a daily scale as well as the patient global impression of change all which showed consistent results to the <unk> improvement in the phase one two.
So very clear on in terms of our primary efficacy outcome that we're looking for.
In terms of the page.
Patient profile of extending from six month since tentative onset to up to one year that was really based on now as we go into phase two.
With a phase two proof of concept clearly you wanted to really make a homogeneous population as we could and so that was the reason for the tight.
Up to six months to really create a homogeneous population based on those very favorable results, which showed a 43% of the patients had at least a 13 point or greater change at both month, one and two.
We now felt that we had the data we needed to really look at longer term Ah patients and that was partially based on data that we present in our corporate deck. That's available on our website, where we showed that patients that had longer duration improved in fact quite dramatically improved and so one of them.
That's what drove the impetus to therefore increase up to one year. We are stratified for patients that are from two months up to six months and longer than six months up to one year, but clearly we believe that it is likely that patients with longer duration of six month will respond favorably as well. So we are taking.
That step wise approach in our development to expand with steps to look at a wider patient population, while still having the capability of showing improvement.
So now, let's turn to OTO 413.
And the enrollment criteria there.
Again, we are really the first company to be focused on identifying improvements in what patients complain about the most when they appear to the physician, which is the ability to hear other people talking in daily environments, which are noisy environments and so speech in noise test or the test to test that speech percept.
<unk>, what we require for these patients are that they have to have a certain minimum level on what we call the digit and noise speech in noise tests, we're using the den as we call it digits of noise as our criteria.
Based on work with Kols to establish the minimum level of speech in noise hearing threshold that we want to test for.
We also assess these patients in terms of their audiometry and so patients can have up to <unk>.
<unk>.
Refound hearing loss so they can be.
Either show no changes on normal audiometry or they can show moderate to severe loss of hearing on audiometry.
But they cannot have profound hearing loss and so that is part of our criteria as well.
Thanks, so much for the response and all the all the good progress.
Thank you Ken I appreciate it.
And our next question is from Charles Duncan from Cantor Fitzgerald go ahead. Please.
Hey, good afternoon, Dave.
Dave Thanks for taking our question congrats on the progress.
Primarily interested in <unk> right now.
Tinnitus program I guess Im wondering in addition to stratify for kind of symptom onset.
You also collecting information on etiology or is that really kind of difficult to nail down.
And then and then secondarily with regard to that time since symptom onset would you anticipate that.
Two to six months patients are harder or less hard to treat versus six to 12 months patients.
Alright.
Thanks Charles.
So, let's talk with with regards to the.
The onset first in the etiology, so we are tracking etiology.
So we are collecting we asked the patients we are looking for an event that resulted in a tentative they can point back to a cochlear oriented event.
That was the trigger for the onset and so we are collecting that information is information that helps both in terms of meeting the criteria for the study, but then obviously, we're also going to be looking at that data in this larger scale phase III study to understand what patients based on etiology might benefit.
More or less than others. So we are collecting that information and looking at that.
With regards to the time since onset and whether or not there is maybe more response that is the question. We are trying to answer now the reason that this is important let's step back is that tinnitus is a.
A persistent effect right now and so as we look at patients patients can have tentative for for years decades, and there is a belief in the field, but at some point it moves from being a co clear origin to more of a centralized problem.
What timeframe that is will vary based on what Kols, you talked to but I think it's important to note that none of us really know because theres never been an effective treatment for tenant just to assess where you can reverse and where it may no longer be reversible.
One of the things I was pleased to see in the phase one two is that the patients that have the longer duration up to that end of the six month responded very well and so as a biologist I don't believe that the body of.
Precise clock that there is a particular time point at which things just shift and Thats what made us comfortable to extend up to one year is that we were still seeing that improvement in the patient.
Fact, very dramatic improvement in patients that had the longer duration in that phase one two study and I think that's what we're looking for in the up to 12 months. Most kols would agree that up to 12 months, it's likely still peripheral.
That's why we didn't push further for now and look further at longer duration than 12 months, what we're going to do is collect this information evaluate it based on that stratification and determine what we see now clearly if we see patients getting better even at.
That habit as long as 12 months that would be further impetus then to look even longer but that's our kind of steps that we're taking and careful product development.
Okay that makes sense, let me now I'd like to sign up for that study, but let's first talk about next steps.
Yeah in terms of this trial readout.
Assume.
Clear results that.
<unk>.
Justify moving forward could you imagine the next study to be one that is.
Small multiple of the size of this study I think it's and closed 140 or could there be a need for a couple of studies, which are much larger and then secondarily how do you.
Plan to deal with bilateral versus unilateral tinnitus in the future.
Okay.
So let's take that.
Yes.
Stepwise here, so first with regards to with positive results what would be our next steps will clearly we'd be having a meeting with the FDA and into phase two meeting to then talk about the next steps I think I do expect that the FDA will require.
Two registration trials.
I think the size of those will be dependent on what we see from the phase II and.
In the power calculations that we can do based on that.
So <unk>.
Clearly with what we saw in the phase one two we do not think that these have to be extremely large studies.
But obviously.
Having more data to base it on that we will be getting from the phase II will help us in our power calculations to determine what that population should look like so that would be our approach. There is to go into the registration trials.
With two registration trials in <unk> based on the power that we would see.
Using the phase II data.
I think in terms of bilateral in how we look at bilateral clearly there are patients about it's about 50 50 roughly.
And clearly we are doing very well enrolling unilateral patients theres, obviously, a lot of patients out there as our enrollment shows and they are eager to be in clinical trials, but we recognize that there are patients suffering from bilateral.
I think importantly, it's important for us to realize the bilateral unilateral or not different diseases. They are tentative and so it just means that the patient.
Through their origin of <unk>.
Cochlear origin of tentative or other biology with such that they got it in both years. So our approach here is to approach. It as what we are developing OTO 313, four is the treatment of tinnitus and that would be whether its unilateral bilateral as you know it's very common in clinical trials to try to create a homogeneous population.
To reduce variability.
So that is why at this point, we're focused on unilateral. However, what we are preparing for is for doing safety evaluation in both unilateral and bilateral patients that would then support the product to be used in bilateral patients by having the data to support that safety.
And so that will be our approach.
Obviously that is a discussion that we want to have with the FDA I think it would also be very possible to see that we might need to do.
Single study in bilateral for example, if the FDA required, but that's something that we're having discussions with them I think importantly, what we think is the most important is to develop the safety data to support both unilateral and bilateral but utilize the unilateral unilateral lateral efficacy to support that it is a treatment that is effective for tenants.
Yes.
413 is obviously a clear indication of the size of the of the treatment audience that we're looking at here. These are high.
Hi, unmet need large populations in that supported by what we're seeing clinically with recruitment.
Now to say that I also think I have to give credit to our team.
And our investigators and clinical site staff, who are doing a fantastic job.
Of working patients through.
Screening and qualification and enrollment in the study so obviously in.
In times of Covid, it's not easy as we know there's lots of different challenges there, but our team has done a very effective job, but I think first and foremost.
Is the number of patients that are looking for treatment.
Dramatically emphasizes the size of these populations and the tremendous unmet need by the number of patients who are looking for therapy I'll give one O 313 is an example, I have never seen so much outreach in a clinical trial of interest as we do with tentative soon is because almost everyone you talk to.
Who knows or have someone who is experiencing that so I think that first and foremost and then an incredible job by all of the people investigators site staff and.
<unk> and teams all working.
With patients who are highly motivated.
Okay, great and how I I don't know if you mentioned this I apologize if you did but how easy or hard is it to find the unilateral versus bilateral I know you just talked about it a little bit, but and also just remind us in the patient and the population I know tinnitus has a huge population, but how how often.
Breakdown of you know versus.
Versus bilateral and is it something that.
Always start says unilateral and progressive so if you're <unk> ultimately if you're doing a trial bilateral is there one year that has to be dealt with a lot differently potentially.
No it breaks down pretty clearly to about 50 50, I won't say that 50 50 is exact but it's very close to being 50 50 of unilateral bilateral now there is some suggestion that maybe some of those.
Unilateral patients may have some slight tinnitus in the in the other ear, but it's just not well recognized given the tentative so that they have in the in the treaty or what.
What we have is the subject here so.
But we are really taking patients that identify as being unilateral uhm and if something that we assess.
So.
But the breakdown is roughly 50 50 and when you look at tentative is a landscape. If we look at U S alone 31 million people in the U S with subjective tentative $8 million of which are moderate to severe. So you can then break it from there are 50 50, you are talking 4 million basically a unilateral and 4 million that our bilateral.
And clearly those each another each individually are very large populations, which is reflected obviously in a moment.
And if I can Oh, sorry go ahead.
No go ahead.
Okay and just yeah last one here was on on the center on Jan Tinnitus going from peripheral to central It seems like you mentioned a lot of Kols would disagree on when that happens but is it possible that there's.
Also a lot of variability between patients for when that that switched from peripheral to central can happen.
Well I think as a biologist I have to say here at this point in time, we really don't know what happens here and this is where are developing an effective therapy will allow us to evaluate that I think I expect populations to be diverse. So I would expect that there are patients who can have tentative for a prolonged period that is still peripherally driven.
And I.
I think one of the things. We also have to look at is really whether or not patients who may have what may be characterized as central tentative couldn't be treated with this and affected by it maybe it still is peripheral in large degree. So I think it's a matter of until we have you know are able to look further with three <unk>.
<unk> and look at longer term, but again, rather than looking at take all comers people who've had sentences for a very long period of time, we're going to do this gradually and work. It out clearly we recognize was tremendous number of patients out there that have had tentative for prolonged period of time it would be wonderful at 313 works for them.
But it is something we will approach stepwise, let's let's look at a homogeneous population that we can clearly define demonstrate activity in that and then it continued to expand expand out from there.
I <unk> I will say of the biologist diff.
Differences among kols of of when exactly the transition can occur whether that's a year two years three years that you moved from peripheral and central no. One really knows no. One has data that really clearly points at that it really is more of an opinion.
And I think what we have to do is just do careful development to look at.
Patient populations, and where we see that effect.
With three third takes great. Thanks for all the color.
Huh.
Thank you for all the color here.
Sure. Thank you Francois.
And our next question is coming from Orange living that problem H C. Wainwright. Please go ahead.
Thanks, guys I have a few questions if you'll indulge me.
313, I think People's dance on us a little bit, but how comfortable comfortable argue that you're gonna have enough power and the different.
Stratified cruise for time from onset such that.
If it's the case that people that think the way that the longer you have on it that are you confident you have enough pain patients in the zero two to six months that you're not going to sacrifice overall statistical significance by expanding and on the three and four months extended observation can you just remind us what trends.
Saw in the phase one too I noticed small but.
Is it likely that you expect efficacy to be getting better getting worse or no idea and you know is there a decent chance that phase III might even have different primary time points and I have a follow up thanks.
Okay.
Well first I think in terms of the power calculations, let's be clear. It is a phase two trial. So we are powering based on.
A limited dataset from the phase one two obviously.
So we.
That's part of why we're doing the phase two trial is to get powering data that will really allow us then to more accurately define a registration program and what the size of those trials must be so I think it is important for people to realize that.
313, the phase two is based on limited data to power so.
It is based on our best judgment there based on the data we have.
And it's really focus on the overall outcome not on the looking at the individual up to six months and six months to 12 months. So.
But at the same time I would say Orange I don't expect that there is a magic cutoff. There clearly is you're looking at the population. The majority of the patients are going to be in that round six months range, which we've already shown in the phase. One two is looking very good from the patients that had it for that longer period of time.
There will be some patients up to one year, but that is why we are stratifying as to her and allow us to have that.
That range it should still allow the power to be effective.
With regards to the phase one too efficacy profile and time period.
I think we saw clearly the patients getting better if you look at Ah go back to our data from patients were clearly improving as we show in those Casey case studies that we have in our corporate deck available on the website, we saw with those patients they were clearly still improving and so that is.
One of the things we're looking at in this phase two trial, our primary endpoint will remain month wanted to but.
But we are looking at months, three and four and that will inform us.
From the standpoint of looking at whether or not these patients continued to improve from a single administration, we haven't even talked about the potential for Retreatment, which we will look at in the future.
But clearly.
As the longer that we see that benefit means that patients would be able to go longer before.
Before we even need to assess whether or not retreat and is necessary in some of these patients I will just remind you as well we're actually going from severe to mild. So there was even a question of whether they need even further treatment.
Particularly if they continued to improve beyond that month too. So all of this I think it's going to be an important part of our learnings from the phase two trial with this larger patient population that will allow US then to make very informed decisions as we continue to progress into registration trials.
Okay and.
You mention O T O 413 being ahead of schedule.
Could you know take the other side of that coin.
Not to criticize I'm, just coming from a place of ignorance unsteady conduct but.
Obviously like you said this is a huge population and it sounds like you are generally taken.
Something something like an all comers population, excluding only profound hearing loss so.
I would imagine in theory once it real quick this study in days or weeks, if not months to get 30 patients into a cohort. So can you just.
You can disclose can you just talk about really.
How are you screening patients out how and why why is it someone not a good candidate for this study and what sort of patient profile that you're really looking for.
Yeah.
Obviously, we are looking at the nature of that patient in terms of their hearing loss. So.
For example, we exclude things like traumatic brain injury would be an example of something that we exclude so there is exclusion criteria there around.
Not going to go into a list of the things, but there are exclusions there for things that.
The types of hearing loss that you may not expect to recover.
But that's a relatively small population like I said, one example would be traumatic brain injury. The other would be really looking at patients and this is where the Dennis we think very effective as using the digital noise test to screen. These patients for their initial speech and noise.
Perception difficulty now I'm part of the reason that this is.
<unk>.
You do have a large number of patients either patients that are self reported they're coming in already complaining about the problem. So I think it's important to start there or if I back up a bit and say where do these patients come from well. These are patients with clinical sites already have seen their not going out needing to recruit them they have them in their patient files.
And it's because these are patients that come in at the majority of what patients when they come in complaining about hearing loss if that ability to hear in the background noise. Other people talking now what clinicians will do is they will analyze that patients who've tried to determine whether or not the patient have some kind of structural damage or injury.
<unk> that if they fixed by surgery. They would help the the hearing or if there's other something else going on now for the majority of patients. That's not the case of just what we typically no noise exposure and aging the resulting hearing loss and so these patients are already coming in there already presenting and in many cases there already.
Being referred to the Audiologist for potential hearing AIDS and so that's the reason we already have a pool of patients there and it's a large pool, what we have been able to do is work with the clinical sites that they can then go in and look at that patient population based on our criteria and screen against it as well as then obviously having these.
Patients do the den test to see if they qualify.
No I think that's an important piece of why we're able to go and approach is the way. We are as we're not happen to go out and advertise. These are patients that are already in that population already identified as having speech and noise hearing difficulty because they are complaining about it.
And and that clearly helps on the enrollment side.
Okay and just on the higher doses is that just going higher because you can get it safe or have you already seen some indication of.
A dose response, maybe somewhere along the way and just can you remind us giving you a formulation that the higher dose mean, it should have a longer duration of action at the site based on your formulations.
Yeah. So first of all let me be clear we have not looked at any data from the phase III has blinded. It's a randomized blinded studies. So we have no access to that data.
So this is based on just as a developer.
Saw very clean.
In fact to.
Remind people about it the safety data actually showed the patients on ODO for 13 actually did better and have fewer adverse effects than the patients on placebo.
And so obviously, a very clean safety profile as well tolerated.
And then also based on other things of looking back we did a very large dose range. There I'll just remind people we did a 30 fold range in our dose. So it was a very strong for different doses that we tested across a broad range, but we felt that we could probably go higher if we developed additional data and capability.
Information and so that's what we did.
We decided that given that well tolerated at the highest dose even though we're very very happy with the efficacy that we're seeing Ah based on that proof of concept. If you recall, 67% of patients improved and at least one of the three speech and noise test them, 33% on all these two of those tests that by a single administrator.
<unk> clearly if we can go higher in dos is something we want to look at and so that is why we step back. We did additional work we took that to the FDA and are happy to say now that we can.
Now look at going into dose escalation and where do that with safety and then be ready to go into a phase two study that would then be a full dose ranging study.
Alright, thanks, guys.
Thank you.
Thank you and I'm not showing any further questions on the queue at this point I would like to turn it over back to the Doctor. They Webber. Please.
Please go ahead of November.
Well. Thank you everyone for participating in our call today, and we hope to meet with many of you at the upcoming Piper Sandler Healthcare conference.
Have a good evening everyone.
And this concludes today's conference call. Thank you everyone for your participation you might not all disconnect.
Have a great day.
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