Frequency Therapeutics — Hearing Loss Regeneration

From what I understand this trial is to give them some idea as to what kind of dosage is appropriate as well as safety I suppose.

Then we get the next phase trial to explore the so-called chaos theory within mathematics.

When you test 3000 people, someone is going to present a problem.

 

I wonder if multiple doses of FX-322 over time would be better or if that is too dangerous.

 

I believe McLean stated that they had better results in vitro growing vestibular hair cells but I don't think there's a way to get the substance into that part of the ear. I could be wrong. Dana White said PRP cured his Meniere's disease but we don't know if he had damage to his vestibular hair cells or a nerve(s) and exactly what the PRP acted on.

 

For the love of God, when are they going to tell us something? I don't know how much longer I can wait. The results, when the next phase will begin... anything

 

Well I spoke to the investigators and they are testing for improvements. They said if they see improvement, some of the participants could be asked to come back for another dose. They are 100% testing for efficiency. Stop saying they aren’t. If you’re new here, be new here, and don’t pretend like you know. Some of us were trying to get into the study and spoke to the doctors and investigators.

I personally screened but didn’t get in because of higher blood pressure fluke.

 

@Deathtotinni You think that this injection from Frequency Therapeutics would cure hyperacusis too? That would be awesome but who knows ...

 

Nobody knows for sure if it will work for hyperacusis. Because we truly don`t know what the root cause of hyperacusis is at this time. But there are some theories about what the cause could be. One theory is as follows, taken from:

https://www.entandaudiologynews.com...iological-mechanisms-of-hyperacusis-an-update

This pathway involves the poorly understood type II auditory nerve afferents, which share many anatomical features with the nociceptive C-fibres of the somatosensory system. While type II afferents are only weakly activated by sound, they are strongly activated in response to tissue or cellular damage in the cochlea. Thus, these fibres may be acting as nociceptors, providing a pain signal to the brain in response to damaging auditory stimulus. In fact, Flores and colleagues demonstrated that auditory brainstem neurons still responded to noxious noise (120dB SPL) in mutant mice bred to have non-functional type I afferents, strongly suggesting the type II afferents were driving this response. It is possible that pain hyperacusis involves increased sensitivity or inappropriate activation of this type II system. Future work must determine:

If this is the cause of hyperacusis with pain then I could see it working. Because as I understand FX-322 starts the regeneration process in all that it comes into contact with. But the question is do new IHC and OHC also mean new type I and II nerve cells.

The article is a very good read about hyperacusis and what could be causing it.

 

If I understand this correctly, the Phase I/II is still really an extended safety study. They may well have an eye on efficacy too, but the question is, will efficacy be actually reported on in the final results?

If it is, then great, but if they don't, that means there'll be no efficacy results until after a formal Phase II. And that process may take the rest of the year.

Testing for harm is obviously crucial to the study. What if those cells indeed grow but cause distorted hearing or worse, actually create hyperacusis symptoms? Anything is possible when so much is unknown.

Could be a lot of donuts and coffee sitting in the car staking out Frequency Therapeutics's headquarters, before real word comes through.

 

The “experts” say we get hyperacusis because our brains are amplifying sound to try to make up for the frequency we can no longer hear. Correct the hearing; correct the sound amplification. I’m just speculating but I’m sure other smarter people have done the same.

 

Haven’t been following this at all. Any update on the first trial?

 

This is the second trial but nothing yet.

 

Infer all you want from this:

 

Let's keep it on topic. Everyone's opinions and comments are valued. We are all in the same boat. No new information as of now.

We never heard anything that came out of the conference.

We are waiting for the results of the latest trial.

Any new information on those items is appreciated.

 

It's frustrating to know that a room full of business execs and probably a few business journalists would have been given a prospectus and advised of some preliminary results in those conferences. How else are you going to get investors to hand over 42 million dollars?

Yet we must wait for final reports to be published.

 

It is a bit odd that the 42 million in funding came in right before the conference. I bet the investors already had all the information they needed and the conference was just a formality. This is good news though since they would have had the results and they must have been positive for them to fork over 42 million.

 

Yes this is true. I am guessing that one dose is not going to be enough and they will have to start testing the effects of multiple doses and the dosing schedule.

What if you end up needing 2, 4, 10, or up to 40 doses to achieve adequate hearing restoration?

Just imagine 40 intratympanic injections...

 

The amount of money going into hearing loss research has gone up considerably over the last 5 years compared to the previous 5 years before that. That’s good!

It’s about time they addressed this large clinical unmet need.

I believe it’ll be another 5 years at least before we are able to get an injection to restore our hearing because of all the trials they have to go through and make sure it’s safe. That’s even if we’re lucky, there are so many things that can stop this going to market. Mammals were not born to naturally regenerate their hearing and interfering with nature may cause more harm than good. I hope they figure it out though, I can put up with hearing loss, not so much the tinnitus.

 

I'd take 40 injections over 40 years of tinnitus any time!

 

With new developments in the works we might not need any injections. A magnet and nano particles can move drugs through membranes now apparently.

 

Injections are far more efficient to deliver more medicine.

 

They may be for now. But you might not need as much of a medicine if it's delivered at the precise location where it's needed.

When you inject a drug a lot of it will dissipate and not end up where it's needed.

 

In the middle ear, as long as you lie on your back with your head tilted and don't swallow, it will stay in there fine and not dissipate, especially if there is enough viscosity. I've had 72 intratympanic injections over the last 2 weeks so I have some experience here.

 

The point is the you need it delivered at the precise location in your cochlea. Even if you manage to keep most of it in your middle ear you actually want it in your inner ear and your cochlea specifically, so much of the medication will be lost no matter how you do it.

Delivering drugs using nano technology to the exact location and preferably to the exact cells that need the drug is actually a thing that's being researched and has been for a decade or so. If (or rather when) it can be made to work it will revolutionize medicine as we know it.

 

Drug dosage always takes into account the absorption rate based on its ingestion method. For example IV has a high absorption rate, but less so for oral, so the dosage is adjusted so your body gets the right amount of meds given the losses "in transit".

I imagine that in an IT delivery to the cochlea, the dosage takes into account the various elements in the way, in particular the amount of compound that permeates to the cochlea via the round/oval windows.

Yes, it will be great. In the meantime, we have to use technology from the present.

 

Love this drug, the thread, and your contributions. I live in Laos, but my hometown is Boston. I wrote Frequency Therapeutics, asking to get involved in the next trial. They returned my email and basically brushed me off and said it's out of their hands, etc.

My ENT would have to refer me. Ain't no ENT here in Laos. You had the chance to speak with investigators. Could you throw me a bone, what can I do to participate.

Any advice? Cheers

 

I wish I knew. The investigators for the last trial might not be the same ones.

 

Curious, when did you send that message? And to which email address?

When I sent an email I was told everything was confidential and we must wait until results are announced.

 

I did not request results, just asked to be in the next trial.

Googled Frequency Therapeutics, they have a contact email listed. I pleaded to be part of the trial, they, or a secretary responded saying I had to be referred by an ENT etc. Blah blah. Just google them, they are in Massachusetts. Sorry I can't be of more help. I don't have a computer and I am on my son's tablet. It's primitive, as I can't check sent emails. On top of that I am in Laos, where telecommunications and internet access is often not very good. Sorry I can't be more help. Perhaps you could email, and try calling if you're in the United States. You never know. Please let us know if you get any info. Again, apologies and good luck.

 

https://www.fiercebiotech.com/biotech/decibel-hires-new-cmo-ahead-proof-concept-hearing-loss-studies

Best case scenario, Frequency Therapeutics has got everything figured out and no longer is in need of this man's skills and abilities, and he has decided to go to Decibel Therapeutics to help them develop their product.

Worst case scenario, Frequency Therapeutics is a complete failure and sinking ship and this dude wanted to get out.

Interpret this how you want

 

Or they simply offered him a LOT of money for his services? I wouldn't read into it too much.