Frequency Therapeutics — Hearing Loss Regeneration

[Daniel Lion]

I also looked through the site again and couldn't find that.

Quotes are really different than paraphrasing, you know.

Hopefully jJurger will set the record straight. It's important to me, as a forum member's interpretation and synthesis is obviously different than the company's speak.

So @Jurger, help us out here.

I am still hopeful and yes, it's probably not healthy... shit!

 

[Matty1996]

Hair cell regeneration in general is something we should be hopeful for and be optimistic about, any advance in the field at all is great thing.

If some people use it to help them cope with their daily struggles, let them- there really is no point other than fruitless negativity to try and spoil that for some people.

 

[JohnAdams]

I also looked through the site again and couldn't find that.

C'mon guys. Get those research skills up.

Secondary Outcome Measures :

1. Extended High Frequency Pure Tone Audiometry [ Time Frame: Screening to Day 210 ]
   Pure tone audiometry will be measured to determine a subject's threshold for hearing at extended high range frequencies (Hz)
   
2. Tinnitus Assessment [ Time Frame: Screening to Day 210 ]
   Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.

Source:

https://clinicaltrials.gov/ct2/show/NCT04120116

 

[JohnAdams]

But regardless, the fact remains this drug will barely treat <3500 Hz as is.

They are increasing the dose in this trial and that could very well get more into the lower frequencies. Stop making up stuff please.

 

[JohnAdams]

When and where did they say that "designed for high frequencies"?

They didn't.

"designed for high frequencies"

That quote/phrase is nowhere in the corporate presentation. Do you know how quotes work?

Here it is:

https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1

 

[JohnAdams]

Don't let @Jurger destroy your optimism with his made up quotes and know it all assumptions about the future.

This drug is dose dependent and with increased dosage it very well could reach much more of the cochlea in significant quantities. We just won't know until this trial concludes so it is irresponsible to say it will or won't for a fact.

 

[JohnAdams]

Dude, they themselves are saying this about their drug, not me. As for excluding patients, why would they do that at this early stage? Maybe phase 2 paints a different picture, but right not they're saying the drug will have a hard time treating loss <3500 Hz. It's on their website.

Give us a quote and a link to it that states that.

 

[ChrisBoyMonkey]

I'm talking about drugs in general. There've been plenty of drugs that showed some efficacy at first only to fail in later phases. Come on man, leave your feelings outside for a second, assuming this drug will pass Phase 2a, 2b and 3 based on what we have now is a coping mechanism, and you know it.

Don't assume I'm hanging on to this for hope. My point is exactly that you talk in general. You don't know what will happen here.

 

[PeteJ]

Only if you believe the truth is that nothing will ever work when in fact that is not the truth. We already have evidence of it. If you want to keep gloating, keep it to yourself. Dragging others down with false negativity is not the way.

I am not gloating. Why would you even interpret that way? What evidence? The other negative is if there is something good coming, it's a long time from now. It will be an unknown too of the extent of how much it will really help. I am sure everyone is keen on learning about your "evidence.' Is it applicable to loud severe tinnitus? As for researchers who are working on hearing loss, are they getting anywhere? I was told they were at least 10 years away, whatever that means.

 

[F-u-T]

I see no reason to be down about this drug at this point. It looks like it will be most effective for high frequencies due to restriction of delivery methods. If the drug works all they have to due is find a more effective delivery method to treat the lower frequencies. If it is effective for hearing restoration even initially at only higher frequencies I think a lot of people will be jumping for joy.

 

[Jurger]

Quotes are really different than paraphrasing, you know.

Hopefully jJurger will set the record straight. It's important to me, as a forum member's interpretation and synthesis is obviously different than the company's speak.

So @Jurger, help us out here.

I am still hopeful and yes, it's probably not healthy... shit!

https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1 Page 22-23

https://edge.media-server.com/mmc/p/nfxzf922 From about 14:30

 

[Jurger]

Could you elaborate on what you are saying... were you saying we are clinging to FX-322 to give us hope from our affliction even though it's an illusion and not viable?

Not saying it's not viable. I'm saying we have very little data to be super enthusiastic about. This drug did two things: 1. It increased 10 dB in 4 patients out of 15 that got it at 8000 Hz. 2. It roughly doubled the word scores of those patients. That's it. This has been discussed at length here. Not trying to be an asshole, but this is turning more into a thread where data is misinterpreted or exaggerated for therapeutic effect instead of discussing the research somewhat dispassionately and keeping us updated on the development of this drug.

 

[Joker]

Hi,

https://investors.frequencytx.com/events-and-presentations

Look on the page 22 from the presentation.

 

[HootOwl]

I think it's important to remember that drug delivery methods are evolving along side hair cell regeneration. Hough is working on nanoparticle delivery. Pipeline already claims complete penetration of the cochlea in animal models. And Otonomy has figured out a way to get their compound for Meniere's deep into the apex in human trials (although from what I understand their methods are patented, which kind of sucks).

Even if Frequency Therapeutics isn't able to get sub 3500 Hz in the beginning that doesn't mean they never will. And in the meantime you have other biotech companies doing just that. I personally think the overlap is heartening, and that there will be something for all of us in due time.

 

[Mathieulh]

Not denying that. In fact, that's why the "designed for high frequency loss" is nonsense to me; it's an excuse for not getting the drug in the entire cochlea. But regardless, the fact remains this drug will barely treat <3500 Hz as is. And that wasn't the vibe on this thread a year ago. It's just to show expectations can shift pretty rapidly regardless of previous positive results.

It's half the equation, once you have a drug that you know works, you can focus on looking for a better delivery system as you will finally have something to deliver, at this moment we have neither.

I shall also add that plenty of people suffer from damages in the high frequencies region of the cochlea and would benefit from the drug (assuming it does work) and the current delivery mechanism as it is.

Finally delivery mechanisms are regarded as medical devices, making the regulatory process much faster than that of actual drugs.

 

[ChrisBoyMonkey]

Why does everyone always want to fight on Thanksgiving?

 

[Daniel Lion]

Not saying it's not viable. I'm saying we have very little data to be super enthusiastic about. This drug did two things: 1. It increased 10 dB in 4 patients out of 15 that got it at 8000 Hz. 2. It roughly doubled the word scores of those patients. That's it. This has been discussed at length here. Not trying to be an asshole, but this is turning more into a thread where data is misinterpreted or exaggerated for therapeutic effect instead of discussing the research somewhat dispassionately and keeping us updated on the development of this drug.

10 decibels for 4 patients at 8000 Hz is huge, to me and obviously to all the investors who poured in money. I forgot how many were in the first trial, maybe 34? How many received the single shot vs. placebo? Pretty impressive from my perspective. ( post edit, jurger said 15 patients and 4 showed 10 dB changes)

The page you referenced said the drug concentrated in the higher frequencies. Perhaps as other forum members have speculated, that with improved delivery, the drug can make it further down the spiral and work its magic on lower frequencies.

I appreciate your call for being dispassionate and you countering the over the top optimism... it's healthy to have a middle ground in this discussion that's grounded in reality, even if it's not what we really want.

Now we can only wait and see, and hopefully REGAIN will have good news, despite one of the founders sobering words, in line with your assertions, about our expectations.

 

[HootOwl]

I am not gloating. Why would you even interpret that way? What evidence? The other negative is if there is something good coming, it's a long time from now. It will be an unknown too of the extent of how much it will really help. I am sure everyone is keen on learning about your "evidence.' Is it applicable to loud severe tinnitus? As for researchers who are working on hearing loss, are they getting anywhere? I was told they were at least 10 years away, whatever that means.

Dude are you serious? This entire part of the forums is dedicated to researchers "getting somewhere". Have you seen the new Pipeline Therapeutics thread? This is a biotech firm with Heller as a lead advisory member that came out of fucking nowhere, with pretty promising data using a biologic that is quite potent for treating synaptopathy. This means there are potential dark horses we haven't even heard of us that could pop up within the next 1-3 years, and add even more options to the mix.

I understand you're suffering and lashing out (I've done that myself irl, ngl) but remember that some of us - myself included - have significant other hearing issues like music/hearing distortion that we would kill to have fixed and we're hoping they can help us get back to our normal lives.

 

[Jurger]

Hair cell regeneration in general is something we should be hopeful for and be optimistic about, any advance in the field at all is great thing.

If some people use it to help them cope with their daily struggles, let them- there really is no point other than fruitless negativity to try and spoil that for some people.

This is the research part of the forum, not the parade part. To say that giving an honest appraisal of the research done by medical companies amounts to "fruitless negativity" is frankly absurd and a sure way of creating an echo chamber in here.

 

[Matty1996]

This is the research part of the forum, not the parade part. To say that giving an honest appraisal of the research done by medical companies amounts to "fruitless negativity" is frankly absurd and a sure way of creating an echo chamber in here.

Lol okay drama queen.

I simply stated any advance in the field is a good thing, no matter how small. Your honest appraisal reeks of doomsaying and oestrogen imo.

 

[thinlay]

Your honest appraisal reeks of doomsaying and oestrogen imo

I smell it too ahahah.

We must remain positive and hopeful, otherwise we have nothing left.
Especially in the history of science, any advancement or innovation, makes people react in fear and distrust. Until this science becomes an element of everyday life.

Twenty years ago if you would have said we would move with a phone as powerful as a computer or that we will know your geographical position all the time, people would have reacted in the same way.

 

[jeff W]

https://www.genengnews.com/insights/targeting-the-inner-ear/

Thank you for this!

 

[JohnAdams]

To say that giving an honest appraisal of the research

Your "honest appraisal" includes invented quotations. I already pointed that out and you never made a retraction.

 

[john paul]

[QUOTE="Jurger, post: 484892, member: 38521"This drug did two things: 1. It increased 10 dB in 4 patients out of 15 that got it at 8000 Hz. 2. It roughly doubled the word scores of those patients. That's it. [/QUOTE]
That's it?
Are you kidding?
This is an insane breakthrough for all of humankind. Pretty much on par with bringing back the dead IMO.

 

[Rb86]

What does it mean to say it increased 10 dB who got it at 8000 Hz. Got what?

 

[JohnAdams]

What does it mean to say it increased 10 dB who got it at 8000 Hz. Got what?

An injection of FX-322.

 

[JohnAdams]

It is becoming apparent that some people are seeking to destroy our rationally based optimism about this drug and hearing loss technology in general. Well, most of us are smart enough to think for ourselves and we aren't even being irrationally over-optimistic about this either, so these people can cry all they want.

 

[HootOwl]

I believe someone on here's mentioned Otomagnetics as being the lead innovator for nanoparticle delivery?

That got me interested so I did some superficial digging and found out that their CEO is pursuing orphan drug status for their delivery method, meaning by the time Frequency Therapeutics hits the general market we might actually have a better delivery method hit at around the same time, possibly even before.

I'm emailing them for some clarification regarding a few other issues (namely delivery to the apex) but this is I think excellent news. I firmly believe the dominoes continue to stack in our favor.

—————

"As the next step, Batra plans to pursue Orphan Drug status, a move that is possible because the childhood cancer population they are addressing numbers less than 200,000 patients. This status will make it possible for the technology to move from Phase 1 Clinical Trials directly to Phase 3. As a result, Batra is aiming to have their platform on the market and improving patients lives by late 2021 at the latest."

 

[john paul]

What does it mean to say it increased 10 dB who got it at 8000 Hz. Got what?

Those who received FX-322 drug, gained 10 dB of hearing at 8000 Hz. Probably more above that but we're still stuck in the dark ages when it comes to hearing tests.

 

[mrbrightside614]

Am I inventing the idea that we were going to get one of these guys on the Tinnitus Talk Podcast, or just one from Hough Ear Institute and Prof. Thanos Tzounopoulos? Either way, should be big time podcasts and I can barely wait for them.