Frequency Therapeutics — Hearing Loss Regeneration

@ZFire, that is exactly right. And this will be the case for at least 10 years, probably 15-20 years.

 

I saw an audiologist back in December who told me that a cochlear implant might be the next step for me. There are lots of things you can have valid anxieties about with cochlear implants. But along with all of them there was this other thought in the back of my mind. What if I do the cochlear implant and it then turns out that FX-322 actually works? I'd had serious doubts about FX-322 for a long time but the dream of being able to hear 'normally' is hard to let go of.

Anyway, no more illusions. I've been freed up a bit in the last few days. Now to deal with the reality of the situation.

 

@d'Wooluf, I agree. What's your audiogram like?

 

The bullishness of some people on here despite the results of the last trial was something to behold. I'm sorry for all those who got burned twice.

Management has been shown to be completely untrustworthy and incompetent. Glad I sold most of my position last year - I'm actually embarrassed I still retained a small % of shares.

Lucchino should be investigated for fraud, pumping the stock on national television weeks before the readout. They are laughing all the way to the bank and deserve every single lawsuit coming their way.

I pity any MS patients who will hold out the same hope we did.

 

Close to profound at the higher frequencies. There's been a big drop off from 1 kHz up over the last few years, so heading south inexorably. Word recognition scores were poor as well which I think is just as important for cochlear implant evaluation. I haven't got the results to hand, sorry.

 

I just forced myself to go and watch that CBS report. The thing is, they were telling people right to their face that Frequency Therapeutics is already under investigation and being sued by investors.

But by pulling this teacher guy out, the physician who injected him commenting that FX-322 must be the cause of his recovery, and then Lucchino's comments about, hey just watch the (yet to be announced) data, I'm in no doubt that this was a carefully constructed report to pump their stock price.

Whether or not those who are suing can prove criminal intent remains to be seen. But there's, in your face, then there's, in yer f*ckin' face. I'm actually shocked.

 

The weird thing about the teacher is that the time between the damage and the injection sounded to be rather long. People don't normally spontaneously get their hearing back a long time after sudden hearing loss. People can sometimes get it a month after, but a year is rather unheard of.

I am a firm believer in Hanlon's Razor. I cannot start thinking they were fraudulent if they already had a threat of lawsuits and FTC going after them if they were. Maybe the teacher was a fluke, however I am not sure. I doubt he was fake or anything like that.

Failure is still progress. It's a chance to acquire valuable information so that others can use it to move forward and do better.

It's only a matter of time. Whether it's five or ten years from now is uncertain. However, scientists continue to learn new things about hearing every year.

 

The entrepreneur appearing on the scene is a welcome addition for most of us -- after all, academia produce these reams and reams of learned research reports that either haven't or don't seem to have cured much in the tinnitus field.

But an entrepreneurial research firm, who have not yet shown that they have the magic bullet to effect a cure, is a risky thing...

Paying the top brass/insiders their salaries in "stock options"! Maybe the law should be changed to not allow this.

Alternatively small-time investors should be warned away from biotechs who do this.

Joeseph Stope, who has never owned a stock in his life... or a bean, for that matter. No, just joking you on that last.

 

It's difficult to tell whether it's sloppy reporting or intentional chicanery but CBS incorporated the strapline, "Sudden Deafness" into their report. They then went on to talk about waking up "losing your hearing" before going straight into interviewing this teacher guy who doesn't describe sudden deafness at all. What he describes is hearing distortion. Everything sounded 'robotic', he says.

Without context that distinction could be quite benign but considering what's just happened, it's raised more than a touch of doubt in my own mind. Anyhow, life and science goes on like you say.

 

We know FX-322 regrows outer hair cells. It’s just that a hearing signal didn’t return. Is it possible that the synapses didn’t reconnect? This would be contrary to that old Stanford video which said they reconnect “like magic.” I wonder if any group is out there thinking about an FX-322 and OTO-413 cocktail.

 

We actually don’t, not in humans. We only know the drug gets in the cochlea (they did two studies on this with patients who were about to be implanted with a cochlear implant). My guess is the drug doesn’t stay in the cochlea long and deep enough to elicit a response. We know from studies on intratympanic dexamethasone injections that intratympanic injections are very unpredictable. That, or the drug doesn’t work at all.

 

I hope not as both drugs failed miserably and didn't do jack. Why waste time flogging a dead horse.

 

I thought it had something to do with a combination of tinnitus and no longer having the clarity that comes with diverse frequencies. Almost like comparing cheap audio equipment to studio quality. I actually have that unpleasant sensation with my unilateral hearing loss. I also attributed it to some hidden hearing loss.

FX-322 was only able to regenerate the ultra high frequencies. That is, those that are outside what is considered to be crucial for human voice frequencies, which makes it a lot harder to argue that it would be beneficial for the majority of people, besides musicians, unless it actually did improve clarity for word recognition. It's outside of the needs of most people.

...Now that I think about it this way, no wonder it was a failure. No matter how much the science makes it plausible, if the design is flawed, and doesn't meet the needs of most people, it's going to be graded a failure regardless, which is probably where that word recognition stuff came from. Perhaps they were trying to persuade its relevancy again.

FX-345 could have been the right formula. It was intended to actually reach the frequency range of human speech. Unfortunately, because of their failing design and strategy for FX-322, we may never know.

I think their plan was to release the FX-322 as a proof of concept to generate funding for research and development of FX-345, but it is hard to get a proof of concept release to fund the better version if the original version isn't beneficial for most people.

What a shame. I prefer seeing research fully completed, not this.

 

I had sudden hearing loss. At first voices sounded robotic after onset. They returned to normal sounds.

 

Whoa whoa, when was this proven? The Phase 2b trial tested for EHF improvement, yet the announcement this week reported no improvement in secondary outcomes (in which EHF audiogram testing was included).

If the drug showed efficacy in any capacity (even in improved EHF hearing thresholds), I believe that would be enough to continue developing the drug, and certainly enough to excite development of FX-345. I believe Frequency Therapeutics knows there is a market of patients who would love improvement in their ultra high frequency hearing; many here report that they have tinnitus in such frequencies, and EHF hearing loss is by far the most prevalent presentation of hearing loss.

 

What do you mean? Like, your brain adapted after?

 

Well, it happened in my left ear and at first everything in that ear sounded robotic. Now it just sounds like I heave hearing loss. I can’t hear birds chirping or women’s voices clearly in my left ear.

 

Bad phrasing I suppose. I meant that "it was intended to." I've had a really busy day, so I rushed that on my smartphone. Sorry lol.

 

Right, no proof IN humans but it did regenerate hair cells ex vivo human tissue in a lab. And the drug made it into the cochlea. Did it regenerate in vivo? We do not have proof it did but there’s good reason to suspect it did. But no hearing was regenerated. Perhaps the synapses didn’t reconnect. Which is why I bring up the hidden hearing loss drug. Maybe they would work together and they failed alone. But I’m just pondering...

 

Mixing both solutions might not be a good idea but maybe dose FX-322 first, then wait a month or two before dosing OTO-413 would have been a better solution.

 

I know you’re one of the biggest advocates here for the absolute need of reliable outcome measures in this field and rightfully so. How many times do we have to go through these initial ‘promising’ results phases, only for it to never amount to anything in the end before we get the memo? A ‘BS detector’ (love the term) is sorely needed.

P.S. No disrespect to Dr. Shore though. To her credit, she has taken the basic science route which is highly commendable, but using the Tinnitus Functional Index (TFI) as an outcome measure will always have me wary. I’m not hyping myself up for potential treatments anymore until there are precise outcome measures. But again, it’s not to diminish Dr. Shore’s work as I do feel like her research is really well grounded and genuine. Far more credible than most.

Weird. I had the robotic voices too, but no sudden hearing loss or measurable hearing loss that followed. I do think distortions is a hearing issue though. There was a time where my distorted hearing made music extremely difficult to comprehend. It came across as unintelligible.

But normally when people think of sudden hearing loss, most will think—the inability to hear certain frequencies and difficulties in speech perception out of nowhere. I agree with @UKBloke about the teacher in that fraudulent CBS video. There’s a lack of clarity in regards to that teacher’s sudden ‘deafness’.

 

This does seem like logical thinking.

Regenerate hair cells, giving FX-322 some time to do this. Later apply OTO-413 to regenerate synapses/ribbons to these hair cells.

Perhaps they both need the other in order for them to work?

 

Sounds like the distortion was diplacusis! You’re lucky it eventually resolved, though I’m sorry the hearing loss remained.

 

Yes but lab findings don’t always translate into real life findings. It would be interesting to study temporal bones of patients who participated in an FX-322 trial and got the drug. I think the lack of results has more to do with not regenerating (enough) hair cells than something that has gone awry with the regeneration process.

If synapses were the problem, you’d expect a shift in Pure Tone Average at the very least.

 

Is your hearing loss in both ears or just one? I have been told I have a case for being a cochlear implant candidate for my left ear (basically severe-profound across the board on that one). My right ear is normal with just a 25 dB dip at 4 kHz at worst, which is why I have not bothered considering a cochlear implant and just lived with hearing out of one ear.

I was going to consider a cochlear implant in my late 30s or early 40s if nothing develops. I am 31 currently.

 

will be 10 years soon enough
fq can go to hell promising cure not delivering shit
why isnt this talked more about? end of an era. they were supposed to be the messiah. this should cause riots in the streets.

cochlear implants are schizo robboto type mecha stuff thatll cost you more than you can afford
dont have high hopes

 

I hope Frequency Therapeutics will continue their hearing loss research if their MS product succeeds. If they get enough profit from it, maybe they can hire hearing loss researchers again.

 

Both. I can just function in quiet with hearing aids. I can't function in noise at all. I've got every reason to at least get evaluated but I'm procrastinating. Everyone tells me they've come a long way in the last few years.

 

I think at this point cybernetics will just bypass the ear altogether, before we have regeneration. It's sad but I guess the cochlea is far much more complex than what we anticipated. Frequency Therapeutics and Otonomy were the only companies that I felt could've delivered at least some results even if only some people would've benefited from it. I'm very lucky my tinnitus turned mild after a few years, but others are not so lucky.

 

I wonder what would happen if some trial subjects call back to report improvements in their hearing at 12+ months. Would they consider restarting the project or is it just dead forever?