Frequency Therapeutics — Hearing Loss Regeneration

[Lucifer]

Is there a possibility Frequency Therapeutics could release results for Phase 2a early, before May 2021?

If 50-75% of patients who got 4 shots of FX-322 already right now show that there is an improvement in their hearing and a reduction of their tinnitus then why not start recruiting for Phase 2b/3 ASAP? Then by May 2021 they can start the clinical trial without delays.

 

[FGG]

Is there a possibility Frequency Therapeutics could release results for Phase 2a early, before May 2021?

If 50-75% of patients who got 4 shots of FX-322 already right now show that there is an improvement in their hearing and a reduction of their tinnitus then why not start recruiting for Phase 2b/3 ASAP? Then by May 2021 they can start the clinical trial without delays.

One of the goals of this trial is to work out the dosing schedule.

And because of this, they can't start recruiting now because they wouldn't have that dosing set into their trial design. When you recruit, you have to let your subjects know what they might be getting in each cohort specifically.

You couldn't post to ClinicalTrials.gov without a trial design. You couldn't contract to the testing sites without a trial design and the patients couldn't sign the agreement without a trial design.

 

[Lucifer]

One of the goals of this trial is to work out the dosing schedule.

And because of this, they can't start recruiting now because they wouldn't have that dosing set into their trial design. When you recruit, you have to let your subjects know what they might be getting in each cohort specifically.

You couldn't post to ClinicalTrials.gov without a trial design. You couldn't contract to the testing sites without a trial design and the patients couldn't sign the agreement without a trial design.

That's unfortunate. COVID-19 really fucked things up for us. Surely there would have been a few people by now who got 4 doses of FX-322 and that it was shown that more doses of FX-322 were more effective than a single dose.

It's a shame we have to wait so long to find out about the effectiveness of additional doses of FX-322.

 

[tommyd87]

Is there a possibility Frequency Therapeutics could release results for Phase 2a early, before May 2021?

If 50-75% of patients who got 4 shots of FX-322 already right now show that there is an improvement in their hearing and a reduction of their tinnitus then why not start recruiting for Phase 2b/3 ASAP? Then by May 2021 they can start the clinical trial without delays.

One of the goals of this trial is to work out the dosing schedule.

And because of this, they can't start recruiting now because they wouldn't have that dosing set into their trial design. When you recruit, you have to let your subjects know what they might be getting in each cohort specifically.

You couldn't post to ClinicalTrials.gov without a trial design. You couldn't contract to the testing sites without a trial design and the patients couldn't sign the agreement without a trial design.

My guess is that if Frequency Therapeutics are savvy - and all the stuff we have seen to date tells us that they are, they are already preparing for this during this trial phase too. There is nothing stopping Frequency Therapeutics from laying the foundations for a trial design now and then tweaking it as they need to such as by changing information in it such as the number of doses required.

Right now I reckon that Frequency Therapeutics are all over this and will also be attempting to proceed with the next trial as quickly as they can after the phase 2A. The evidence is clear that Frequency Therapeutics wants to get FX-322 released as quickly as possible and will do everything that they can to expedite this matter.

 

[FGG]

My guess is that if Frequency Therapeutics are savvy - and all the stuff we have seen to date tells us that they are, they are already preparing for this during this trial phase too. There is nothing stopping Frequency Therapeutics from laying the foundations for a trial design now and then tweaking it as they need to such as by changing information in it such as the number of doses required.

Right now I reckon that Frequency Therapeutics are all over this and will also be attempting to proceed with the next trial as quickly as they can after the phase 2A. The evidence is clear that Frequency Therapeutics wants to get FX-322 released as quickly as possible and will do everything that they can to expedite this matter.

They will clearly prepare of course but not "recruit early" as was suggested.

 

[Billy_Shears]

The Phase III clinical trial of FX-322 will be somewhat more time-consuming it will seem than previous segments of the process. Despite the results of Phase 2a, the third and final phase will involve many more participants across the United States, perhaps several hundred. These potential participants, of course, will need to satisfy selective criteria to order to be included in the research - easier said than done.

However, recruitment will involve the help of the many research centers and ENT physicians, many of whom took part in the Phase 2a trial with a completion eight days early on September 22, 2020. Compiling the data and publishing the report to the FDA after the final participant on day 210 will also take what will seem to be forever, especially if you are one who has to endure agonizing tinnitus day after day.

The good news is that we are so close to the answer and there is nothing 'unfortunate' about anything along the path that Frequency Therapeutics has taken. More good news if you have noticed is that those brilliant minds at Frequency Therapeutics have a lot of empathy for individuals with hearing loss and tinnitus and its debilitating effects.

The process is slow because there is so much involved in clinical trials and bringing a pharmaceutical to market. I think of liability issues, lawyers, and class-action lawsuits but I also know that help is coming soon in a relatively brief time. I'm fine with that.

 

[Lucifer]

Will Frequency Therapeutics let us know when they finish dosing the final patient?

 

[tommyd87]

Will Frequency Therapeutics let us know when they finish dosing the final patient?

I'd assume that they'd finish dosing the patient before the end of the year.

 

[Diesel]

I'd assume that they'd finish dosing the patient before the end of the year.

It should be by the end of October since they announced finishing enrollment in September. It wouldn't surprise me if they released a "last dosage" announcement.

 

[tommyd87]

I'm not ruling out Frequency Therapeutics coming up with a better delivery method, but it clearly seems that it's a non-trivial thing to do, and they haven't given any sign that they have something for it in the works. In recent conferences they've stated that FX-322 was "designed" to target the higher frequencies. This is spin.

Don't get me wrong, I'll be thrilled if tomorrow they announce that they have a reformulation ready that can hit the lower frequencies, but I haven't seen any indication that that's what they have in store.

Frequency Therapeutics has seemed to be very focused on just getting FX-322 released in its current form and from all the hints this is because it is the easiest way to get FDA approval.

Furthermore Frequency Therapeutics has not really gotten a need to enter into an arrangement with a dosing company to try to improve dosing when firstly this isn't necessary to pass FX-322 through the FDA trials and secondly it would not be commercially reasonable to do so when they have no reason to do something like this now either.

It seems to be fairly evident that Frequency Therapeutics have not commented further about looking at redosing and making comments about FX-322 only working for the very high frequencies because this remains very consistent with their behaviour to date.

Frequency Therapeutics' major concerns are to get FX-322 approved as quickly as possible in order to be able to sell it and to make very conservative comments which won't get them in trouble with the regulators. These conservative comments have been made and seen throughout the clinical trial process. Furthermore the dosing issues make zero sense to deal with now when firstly they haven't finished their trials and secondly there is no commercial reason to enter into an agreement with a firm to look at redosing without all this information.

Thus I believe that it is very likely that Frequency Therapeutics will look at redosing, however it will not be done now as there is simply no point for them to do so and secondly it is much easier for Frequency Therapeutics to play around with dose delivery post release when they are actually able to do so with freedoms unlike during a clinical trial where they have fairly substantial criteria to fulfil and restrictions placed on them.

 

[patorjk]

Frequency Therapeutics has seemed to be very focused on just getting FX-322 released in its current form and from all the hints this is because it is the easiest way to get FDA approval.

Furthermore Frequency Therapeutics has not really gotten a need to enter into an arrangement with a dosing company to try to improve dosing when firstly this isn't necessary to pass FX-322 through the FDA trials and secondly it would not be commercially reasonable to do so when they have no reason to do something like this now either.

It seems to be fairly evident that Frequency Therapeutics have not commented further about looking at redosing and making comments about FX-322 only working for the very high frequencies because this remains very consistent with their behaviour to date.

Frequency Therapeutics' major concerns are to get FX-322 approved as quickly as possible in order to be able to sell it and to make very conservative comments which won't get them in trouble with the regulators. These conservative comments have been made and seen throughout the clinical trial process. Furthermore the dosing issues make zero sense to deal with now when firstly they haven't finished their trials and secondly there is no commercial reason to enter into an agreement with a firm to look at redosing without all this information.

Thus I believe that it is very likely that Frequency Therapeutics will look at redosing, however it will not be done now as there is simply no point for them to do so and secondly it is much easier for Frequency Therapeutics to play around with dose delivery post release when they are actually able to do so with freedoms unlike during a clinical trial where they have fairly substantial criteria to fulfil and restrictions placed on them.

For context, this is from the OTO-413 discussion.

I don't think there's anything I disagree with you on, nor do I think your comments really go against what I was saying. Frequency has a drug delivery problem, however, their drug is still impressive and has great potential for upper range hearing and possibly tinnitus. I believe in Frequency and even own shares in the company.

Frequency are most likely working on this problem, however, they've shown no outward signs that they have anything ready to test. Their plan may be to get through Phase 2a first, but we don't know. There has been some talk of a "hearing loss due to age" study, and I think that would be a mistake for them without a reformulation (well, technically it might work for them since the upper ranges go first, but I'd like to see them tackle the drug delivery problem - as I think that would change this into a wonder drug).

 

[Diesel]

Frequency are most likely working on this problem, however, they've shown no outward signs that they have anything ready to test. Their plan may be to get through Phase 2a first, but we don't know. There has been some talk of a "hearing loss due to age" study, and I think that would be a mistake for them without a reformulation (well, technically it might work for them since the upper ranges go first, but I'd like to see them tackle the drug delivery problem - as I think that would change this into a wonder drug).

There are a few factors here to consider regarding a delivery method that goes deeper into the cochlea.

1. We don't yet know if multiple doses is enough to help achieve the goal of deeper cochlea delivery as being tested in the Phase 2A. So, there's no reason for Frequency Therapeutics to acknowledge it as an issue at this time; since they may not know yet.

2. As a publicly traded company, they have to be extremely careful about speculation. Even saying that they may be working on an updated delivery method creates two layers of speculation. The first, is that they're speculating that the current drug wont go deeper at all during the Phase 2A. The second is that they believe whatever they're working on will work. We have seen that Frequency Therapeutics is communicating to the public in an extremely conservative way; so there's no incentive for them to add speculation / change communication on delivery method, when FX-322's hearing restoration data is enough at this time.

3. The Osbourne Effect. Where people wait to buy a "new" product knowing an even better one is just around the corner. The FX-322 that we see today going through the clinical trials is what we're all going to get once it becomes available. That includes all of its limitations. If Frequency Therapeutics suddenly starts talking about a new delivery method/formulation of FX-322; many people (including doctors) will just wait to start receiving the new-and-improved version. This could be DEVASTATING to Frequency Therapeutics if FX-322 comes out, and after all of the time invested, people defer treatment to get the FX-322 "2.0" in a couple years. There have also been SEC investigations into this type of problem before (See Nikola), which can be extremely damaging to a firms liquidity / consumer confidence.

4. Partnerships. For all we know, Frequency Therapeutics may be working on a deal with Otonomy or others to license their "gel" for the delivery of FX-322 "2.0." Deals like this may take years to establish. They will in no way announce anything, especially if its between two publicly-traded companies, until the ink on the deal has dried. Note that Carl LeBel used to work for Otonomy, so it is possible that his relationship with this firm could be leveraged to help get access to a superior delivery formulation (assuming Otonomy's is for FX-322... but we all really have no idea).

 

[patorjk]

There are a few factors here to consider regarding a delivery method that goes deeper into the cochlea.

1. We don't yet know if multiple doses is enough to help achieve the goal of deeper cochlea delivery as being tested in the Phase 2A. So, there's no reason for Frequency Therapeutics to acknowledge it as an issue at this time; since they may not know yet.

2. As a publicly traded company, they have to be extremely careful about speculation. Even saying that they may be working on an updated delivery method creates two layers of speculation. The first, is that they're speculating that the current drug wont go deeper at all during the Phase 2A. The second is that they believe whatever they're working on will work. We have seen that Frequency Therapeutics is communicating to the public in an extremely conservative way; so there's no incentive for them to add speculation / change communication on delivery method, when FX-322's hearing restoration data is enough at this time.

3. The Osbourne Effect. Where people wait to buy a "new" product knowing an even better one is just around the corner. The FX-322 that we see today going through the clinical trials is what we're all going to get once it becomes available. That includes all of its limitations. If Frequency Therapeutics suddenly starts talking about a new delivery method/formulation of FX-322; many people (including doctors) will just wait to start receiving the new-and-improved version. This could be DEVASTATING to Frequency Therapeutics if FX-322 comes out, and after all of the time invested, people defer treatment to get the FX-322 "2.0" in a couple years. There have also been SEC investigations into this type of problem before (See Nikola), which can be extremely damaging to a firms liquidity / consumer confidence.

4. Partnerships. For all we know, Frequency Therapeutics may be working on a deal with Otonomy or others to license their "gel" for the delivery of FX-322 "2.0." Deals like this may take years to establish. They will in no way announce anything, especially if its between two publicly-traded companies, until the ink on the deal has dried. Note that Carl LeBel used to work for Otonomy, so it is possible that his relationship with this firm could be leveraged to help get access to a superior delivery formulation (assuming Otonomy's is for FX-322... but we all really have no idea).

I completely agree. My original point in the other thread was simply that drug delivery is king and if Otonomy really can get to the lower frequencies, and their drug works, then they will have something amazing on their hands.

I'm very curious about multiple injections, but I don't think we'll see anything dramatic. In a recent talk, the CEO of Otonomy threw some shade Frequency Therapeutics' way by saying Otonomy's drug delivery method was more efficacious than getting multiple injections. How much more? We'll have to wait until the results of OTO-413 (if that drug works).

Frequency Therapeutics could be working on something, but they haven't shown their hand and they probably won't due to some of the reasons you mentioned. Hopefully both drugs work and drive the price down. I have a feeling this kind of treatment is going to initially be very expensive.

 

[FGG]

I completely agree. My original point in the other thread was simply that drug delivery is king and if Otonomy really can get to the lower frequencies, and their drug works, then they will have something amazing on their hands.

I'm very curious about multiple injections, but I don't think we'll see anything dramatic. In a recent talk, the CEO of Otonomy threw some shade Frequency Therapeutics' way by saying Otonomy's drug delivery method was more efficacious than getting multiple injections. How much more? We'll have to wait until the results of OTO-413 (if that drug works).

Frequency Therapeutics could be working on something, but they haven't shown their hand and they probably won't due to some of the reasons you mentioned. Hopefully both drugs work and drive the price down. I have a feeling this kind of treatment is going to initially be very expensive.

FYI the multiple injections shade was likely referring to contrasting OTO-104 with IT Dexamethasone since they are trying to prove their extended release Dexamethasone is better (that's what OTO-104 is) than that standard of care for phase 3. This may or may not be relevant to drugs that may not have the apparent "polarity" problem that steroids have.

 

[patorjk]

FYI the multiple injections shade was likely referring to contrasting OTO-104 with IT Dexamethasone since they are trying to prove their extended release Dexamethasone is better (that's what OTO-104 is) than that standard of care for phase 3. This may or may not be relevant to drugs that may not have the apparent "polarity" problem that steroids have.

I'm not sure I read Dr. Weber's comments the same way you do. What you're saying could also be true, but he's not talking specifically about OTO-104 at that point, he's talking about his company in general and how their delivery method is the corner stone (though he mentions OTO-104 as an example of its success). His exact quote on their delivery method I think is telling: "allowing you to expose all of the target issue, and this is where we see others struggling, they have to do multiple injections trying to get enough drug in the ear" [1]

Who are the "others" he is seeing struggle? And notice that he explicitly mentions during this segment that their drugs can permeate throughout the entire cochlea. I may be overthinking things, but Otonomy is very aware of what Frequency Therapeutics is doing, and I think this is his way of subtly trying to explain why he thinks his company has an advantage with their drugs. I could very well be wrong though.

[1] https://wsw.com/webcast/oppenheimer5/otic/2715615 - starts at 18:25

 

[FGG]

I'm not sure I read Dr. Weber's comments the same way you do. What you're saying could also be true, but he's not talking specifically about OTO-104 at that point, he's talking about his company in general and how their delivery method is the corner stone (though he mentions OTO-104 as an example of its success). His exact quote on their delivery method I think is telling: "allowing you to expose all of the target issue, and this is where we see others struggling, they have to do multiple injections trying to get enough drug in the ear" [1]

Who are the "others" he is seeing struggle? And notice that he explicitly mentions during this segment that their drugs can permeate throughout the entire cochlea. I may be overthinking things, but Otonomy is very aware of what Frequency Therapeutics is doing, and I think this is his way of subtly trying to explain why he thinks his company has an advantage with their drugs. I could very well be wrong though.

[1] https://wsw.com/webcast/oppenheimer5/otic/2715615 - starts at 18:25

It would be incredibly premature and unwise for Weber to be commenting on his expected results of a blinded study which is still ongoing. That doesn't make sense to me. Frequency Therapeutics' phase 1 did not have the multiple dosing.

As far as others, there have been attempt to come up with multiple dosing strategies with Dexamethasone for Meniere's. It makes way more sense to me that that is what he would be referring to.

 

[patorjk]

It would be incredibly premature and unwise for Weber to be commenting on his expected results of a blinded study which is still ongoing. That doesn't make sense to me. Frequency Therapeutics' phase 1 did not have the multiple dosing.

As far as others, there have been attempt to come up with multiple dosing strategies for Dexamethasone with Meniere's. It makes way more sense to me that that is what he would be referring to.

He's not commenting on expected results or saying anything about drug effectiveness. He's making a general comment about the delivery mechanism his company has developed. If he wanted his comment to specifically apply only to OTO-104, I think he would have done so. I think he purposefully kept his comment general and geared towards the strength of the delivery rather than a specific drug. His comment probably applies across the board to any company trying to deliver drugs to the ear, with Frequency Therapeutics being one of those companies (who notably seem to be struggling to deliver their drug to the lower frequencies).

 

[FGG]

He's not commenting on expected results or saying anything about drug effectiveness. He's making a general comment about the delivery mechanism his company has developed. If he wanted his comment to specifically apply only to OTO-104, I think he would have done so. I think he purposefully kept his comment general and geared towards the strength of the delivery rather than a specific drug. His comment probably applies across the board to any company trying to deliver drugs to the ear, with Frequency Therapeutics being one of those companies (who notably seem to be struggling to deliver their drug to the lower frequencies).

I see your point but the only thing he has to compare it to technically would only be Dexamethasone.

 

[tommyd87]

He's not commenting on expected results or saying anything about drug effectiveness. He's making a general comment about the delivery mechanism his company has developed. If he wanted his comment to specifically apply only to OTO-104, I think he would have done so. I think he purposefully kept his comment general and geared towards the strength of the delivery rather than a specific drug. His comment probably applies across the board to any company trying to deliver drugs to the ear, with Frequency Therapeutics being one of those companies (who notably seem to be struggling to deliver their drug to the lower frequencies).

I get what you are referring to and right now I know that the theory is that the method of dosing/medicine make-up which Otonomy has utilised for OTO-413 is apparently actually superior to the dosing methods used by Frequency Therapeutics with FX-322 based on some reports.

Right now however, we have only seen the benefits attained in lab trials.

Therefore it would be pretty game and unwise for Otonomy to say that they have a better drug delivery method. That would be at least until after the OTO-413 phase 1/2 trial results are known at which point they actually are going to have information to back these claims up.

FYI the multiple injections shade was likely referring to contrasting OTO-104 with IT Dexamethasone since they are trying to prove their extended release Dexamethasone is better (that's what OTO-104 is) than that standard of care for phase 3. This may or may not be relevant to drugs that may not have the apparent "polarity" problem that steroids have.

Can you please explain this in more simple terms? I understand the polarity part, because these drugs are a lot easier to get working in the ear than steroids, however I don't understand the reference to their Dexamethasone being better than the standard of care for phase 3. Do you actually mean phase 2, since Otonomy is currently completing the OTO-104 phase 3 trial?

 

[FGG]

Can you please explain this in more simple terms? I understand the polarity part, because these drugs are a lot easier to get working in the ear than steroids, however I don't understand the reference to their Dexamethasone being better than the standard of care for phase 3. Do you actually mean phase 2, since Otonomy is currently completing the OTO-104 phase 3 trial?

I mean that multiple IT injections of Dexamethasone in its current formulation is one of the standard treatments for severe Meniere's. OTO-104 is being tested on Meniere's patients and aims to prove their drug produces more vertigo free days (if their drug was equivalent to multi dose Dexamethasone there wouldn't be much point in it).

OTO-104 is "Otividex" which is a special extended release formulation of Dexamethasone for IT injection.

 

[Paulmanlike]

Very, very interesting thread.

I wanted to ask, do you think Frequency Therapeutics might release some 'mid-term' results about the phase 2 trial? Like would they release any information, at all, like evidence of repeated dosings is pointing towards greater efficacy?

Or will they keep that information locked up until the day it's all released? I'm also taking it that the guys in charge are all blinded to it anyway, so they won't even know. Do they have rules, being a publicly traded company, that they can't offer any speculative statements until the full Information is released?

I'll also go back to the delivery method and the speculation that with repeated dosages FX-322 reaches further into the cochlea and bypass unaffected cells. Have you thought of the possibility that FX-322 will regenerate hair cells whether they are damaged, destroyed or healthy and it has no way of knowing what to replicate or not? So whatever FX-322 gets to first, it could just replicate those hair cells regardless whether they are damaged or not. I know there was a statement by Frequency Therapeutics about this, but how would they even know?

I'm betting repeated dosages won't achieve much greater improvements in the lower frequencies and thus a more precise delivery method would need to be invented... However I hope I am wrong! It seems too simple to me that just injecting more of FX-322 will keep treating hearing loss more and more across the spectrum.

 

[Diesel]

Very, very interesting thread.

I wanted to ask, do you think Frequency Therapeutics might release some 'mid-term' results about the phase 2 trial? Like would they release any information, at all, like evidence of repeated dosings is pointing towards greater efficacy?

Or will they keep that information locked up until the day it's all released? I'm also taking it that the guys in charge are all blinded to it anyway, so they won't even know. Do they have rules, being a publicly traded company, that they can't offer any speculative statements until the full Information is released?

I'll also go back to the delivery method and the speculation that with repeated dosages FX-322 reaches further into the cochlea and bypass unaffected cells. Have you thought of the possibility that FX-322 will regenerate hair cells whether they are damaged, destroyed or healthy and it has no way of knowing what to replicate or not? So whatever FX-322 gets to first, it could just replicate those hair cells regardless whether they are damaged or not. I know there was a statement by Frequency Therapeutics about this, but how would they even know?

I'm betting repeated dosages won't achieve much greater improvements in the lower frequencies and thus a more precise delivery method would need to be invented... However I hope I am wrong! It seems too simple to me that just injecting more of FX-322 will keep treating hearing loss more and more across the spectrum.

It is not out of the ordinary for firms to release an "Interim Analysis" for a really long Phase 2 or 3. I'm having a hard time seeing why Frequency Therapeutics would do this for the Phase 2A.

I do think they might be working on other non-FDA trials relating to other types of hearing loss that they may release between now and the end of Q2-2021.

 

[tommyd87]

It is not out of the ordinary for firms to release an "Interim Analysis" for a really long Phase 2 or 3. I'm having a hard time seeing why Frequency Therapeutics would do this for the Phase 2A.

I do think they might be working on other non-FDA trials relating to other types of hearing loss that they may release between now and the end of Q2-2021.

I agree with your analysis that Frequency Therapeutics won't release data mid phase 2a, especially when this is double blinded and also doing so would actually require Frequency Therapeutics to make assumptions because they cannot link the results. Assumptions are not something we have seen Frequency Therapeutics make anytime and I don't see them starting to do this now.

I think that there will be further information released by Frequency Therapeutics on other research for other types of hearing loss like sudden hearing loss etc. Essentially I expect that these might actually form a fair bit of Frequency Therapeutics' work in the near future and along with the phase 2b or phase 3 trial. This is because Frequency Therapeutics would use this information in order to assist them to offer treatment to these groups but can also simultaneously use this data to get a broad understanding of what is and is not currently working with their treatment.

 

[Gb3]

@tommyd87 I thought they were already testing subjects with sudden hearing loss?

 

[Michael01]

Essentially I expect that these might actually form a fair bit of Frequency Therapeutics' work in the near future and along with the phase 2b or phase 3 trial

Is there any way to tell how soon after the trials FX-322 will be available for full worldwide release? As it does look very promising but do we know when it'll be available for people that really would like to try it?

 

[Billy_Shears]

Very, very interesting thread.

I'm betting repeated dosages won't achieve much greater improvements in the lower frequencies and thus a more precise delivery method would need to be invented... However I hope I am wrong! It seems too simple to me that just injecting more of FX-322 will keep treating hearing loss more and more across the spectrum.

Your assumption pertaining to repeat dosages not improving the lower frequencies is valid in my opinion, however, it is known that an improvement on delivery of FX-322 throughout the cochlea is on the 'front burner' and will be forth-coming. In the early study conducted on mice total hearing loss was successfully restored to normal levels, in part because the size of the cochlea is so small - drug delivery throughout was not an issue as is the case in humans, just speculating.

Since the clinical trial is specifically designed for the treatment of sensorineural hearing loss lower frequencies less than 2 kHz may not be the ultimate goal at this time.

 

[tommyd87]

Is there any way to tell how soon after the trials FX-322 will be available for full worldwide release? As it does look very promising but do we know when it'll be available for people that really would like to try it?

No idea. It is up to Astellas to determine the timeframe of FX-322's release as they have the rights globally outside of America.

Most likely the release wouldn't be until either mid to late 2021 at the earliest, as Frequency Therapeutics still need to run at least one further clinical trial. Though a more realistic release date would possibly be 2022-2023 since there is potentially going to be some delays between starting the second trial, enrolling the candidates and submitting the results to the FDA for approval. Right now I can safely assume that Frequency Therapeutics will be doing all they can to expedite FX-322's release and thus they will be pushing to get FX-322 out in the shortest time possible.

I do think that the rules regarding compassionate use and early release will definitely apply in countries which acknowledge America's approvals process and vice versa. So Australia could actually obtain FX-322 very soon after it is approved in America. At this stage I guess that the only thing that might prevent its release is if no one was willing to treat you with it, though it is incredibly likely that we will find doctors in Australia that are going to do this.

 

[Paulmanlike]

These dates for 2022-23 appear very optimistic. I was under the impression it would be more like 2026-2027. The reason being is that it only went through phase 1 at the end of 2017 and on average it takes what 10 years to get through clinical trials.

Also for phase 3, it requires hundreds of patients and recruiting them won't be easy. How many people are available and willing to get an unknown drug injected to them this early on - even with good preliminary data?

Not to mention it will cost millions of pounds - how are they going to fund it? Or will Astellas be funding it, haven't Frequency Therapeutics got a deal for them to fund milestone payments?

 

[Jurger]

@tommyd87 I thought they were already testing subjects with sudden hearing loss?

Sudden hearing loss is included. They also found the drug worked regardless of the origin of the hearing loss they included (I believe the other one is 'regular' acoustic damage).

 

[Jurger]

I agree with your analysis that Frequency Therapeutics won't release data mid phase 2a, especially when this is double blinded and also doing so would actually require Frequency Therapeutics to make assumptions because they cannot link the results. Assumptions are not something we have seen Frequency Therapeutics make anytime and I don't see them starting to do this now.

I think that there will be further information released by Frequency Therapeutics on other research for other types of hearing loss like sudden hearing loss etc. Essentially I expect that these might actually form a fair bit of Frequency Therapeutics' work in the near future and along with the phase 2b or phase 3 trial. This is because Frequency Therapeutics would use this information in order to assist them to offer treatment to these groups but can also simultaneously use this data to get a broad understanding of what is and is not currently working with their treatment.

I'm not expecting any information on the trial results until they are fully released.

Maybe they'll announce the final dosage of the last patients. I do hope we'll see some more information on what they will do with the private placement funds. A couple of months ago they said something about further research into FX-322 and the severity of the hearing loss it can treat. Still hoping for that reformulation or partnership with Otomagnetics or something.