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Of course every scientist that fails should just quit.

According to his Linkedin, Will McLean (on whose research FX-322 was founded on) left Frequency Therapeutics in April 2022 and is now Chief Scientific Officer at a new (unnamed) company. According to his profile, he is still working on regenerative medicine to restore hearing.

Great news.

There is absolutely no reason to assume that the reason FX-322 failed is because the supposed regenerated hair cells had no nerve endings. Hair cells without nerve endings result in hidden hearing loss. So you would expect a shift in audiogram results, but problems with hearing-in-noise for...

And if I might add: the hearing improvement must last long term. Some FX-322 patients lost their ‘gains’ after 1/2 years. Either the hair cell is there, or it isn’t there. Hearing loss drugs that need to be repeated yearly, hoping it will have the same effect as last time, is just ridiculous.

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...

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...

Fully agreed. I thought something was weird when they kept changing the goal posts after every trial. They already did that in 2019 when almost nothing showed up on the audiogram in the first Phase 1/2. And some people here did not want to have an honest debate about that.

Yes, sudden hearing loss/deafness happens all the time, but I do agree that judging from what we know of the efficacy of FX-322, he seems to be extremely responsive to it.

Interesting. I wonder when the gentleman participated in the trial. If it was one of the earlier ones, his recovery could be attributed to the natural healing that occurs over time in a lot patients with sudden deafness (particularly word recognition). Also, I wonder how much he recovered...

Mogrify and Astellas announce collaboration to conduct research on in vivo regenerative medicine approaches to address sensorineural hearing loss Cambridge, UK, Tokyo, Japan, 05 July 2022: Mogrify Limited (CEO: Darrin M. Disley, Ph.D., “Mogrify®”), a biopharmaceutical company transforming the...

Otoprotective drugs are interesting to me as a hearing loss patient, because they can provide insights with regards to getting drugs into the inner ear. One of my concerns is that intratympanic injections have significant drawbacks in terms of getting drugs deep and long enough in the cochlea to...

Looks to me as if PIPE-505 did not achieve the results they had hoped for.

Just watched this Fireside chat by Frequency Therapeutics: https://www.webcaster4.com/Player/Index?webcastId=45378&g=a6b36ac8-0c79-4079-ba1b-7631deefbbcd&uid=6671331&sid= An interesting moment was when Chris Loose was asked if FX-345 could leapfrog FX-322. He said it was “too early to...

It was a missed opportunity. The presenter asks the question at 25:45. Franck says ‘there’s a story there that kind of makes sense’ but he doesn’t actually explain it. Anyway, we’ll see how the 208 study unfolds. If it’s still the case 65% of patients don’t improve and those that do can lose...

You’re confusing criticizing a drug for its efficacy and instant gratification. Frequency Therapeutics themselves didn’t talk about word recognition until after the first trials didn’t show audiogram improvements. We as patients have no holy obligation to morally support any particular drug. I...

Possibly, but that would only make sense if supporting cells responsible for regrowth of IHC respond better to the drug somehow. Why would that be the case? It wasn’t the case in pre-clinical work. Supporting cells are supporting cells. Furthermore, I haven’t heard Frequency Therapeutics give...

The press release made no claims about which region the drug and didn’t hit. Frequency Therapeutics Shares Clinical Data From Exploratory Study Confirming Delivery of FX-322 to the Cochlea I doubt it’s even possible to determine the region of the cochlea the drug hits this way. I think they...

I just don’t understand these analogies. 1. The hearing range people need the most is in the 125-8000 Hz range. The speech range is in the 125-5000 Hz range. FX-322 doesn’t hit those frequencies. Frequency Therapeutics has had to temper expectations of the drug significantly (earlier...

“Just crank your hearing aids up to 110 dB bro.”

I thought it was telling one of the questions was why they don’t focus on FX-345...

There comes a point where we just have to admit the drug doesn’t work that well. When the Phase 1/2 trial hardly did anything for audiograms. “Well, word scores are more important anyway.” When the Phase 2a trial failed. “Well, people lied”. When the presbycusis trial failed. “Well, they’re...

Reality.

On the one hand I’m glad they’ve come with something new, but on the other hand I can’t help but feel “here we go again”. It’s like we’re back in 2017 when FX-322 was promising.

And yet here we are with a better understanding of how the inner ear works every day and multiple companies pursuing treatments. Maybe we’ll get hearing protection drugs first - of which the regeneration field will benefit tremendously in terms of drug delivery - but if we can believe the...

At the same time, I can’t really blame people on here looking to get their hopes up instead of information. Treatment for inner ear hearing loss still consists of hearing aids and CIs, basically technologies that have been around for 50-60 years that do nothing for the underlying problem. It’s...

Was this talk posted already? Couple of interesting points, particularly in the Q&A.

Back in the day people on here wanted to petition Trump to get this drug... And even now, Frequency’s monthly presentation still displays this drug targeting the 20,000 to 6,000 Hz area of the cochlea. I would be happy with getting PTA improvements in that range, but they haven’t shown any.

Besides: better PTA on human speech frequencies = better speech recognition. It’s not like they don’t overlap.

By now I’m more interested in their R&D efforts than a drug that’s not designed to improve pure tone average, not even the extended range. Based on their previous trial, any speech perception gains you make might not even last that long.

The stock could tank even further and people here will tell you it’s all part of Lucchino’s Grand Plan. The truth is, of course, that they haven’t got it (yet?).

They can announce results AND follow patients for a longer period of time afterwards. One doesn’t exclude the other.

FFS, they said early 2021 when they announced the trial.

Why the thin-skinned reaction? It's not like it would be he first time a company overpromises and underlivers in the hearing field. "Local intratympanic administration into the middle ear would be a preferable option in this case, and the only option for many newly emerging classes of drugs...

Can you point me to a source or is that your interpretation of ‘throughout’. I find it hard to believe it’s accurate, because it’s well documented that it’s very hard to reach the apex of the cochlea via intratympanic delivery, let alone in stable, therapeutic concentrations.

What’s ‘throughout the inner ear’? I want a delivery method that can hit all frequencies of the audiogram (250-8000 Hz).

New trial (Phase 2) about to commence: A Trial of LY3056480 in Patients With SNLH (VESTA) What’s interesting is that they will use different dosage schedules. Once every couple of days, once weekly and once every two weeks, each schedule four injections. Learning from Frequency Therapeutics...

How is a “previously disclosed” trial a secret? If I’m correct this is the study of which they already shared results concurrent with the failed Phase 2a study.

I disagree. In Phase 1/2 the drug didn’t result in PTA improvements and WR scores improved marginally in about 35% of patients. Frequency Therapeutics didn’t even talk about WR until after the results of Phase 1/2. I wasn’t impressed after Phase 1/2, and for good reason.

Apparently they are contacting patients who didn’t get into previous trials that their next trial is about to start (source: people on Facebook).

They definitely put a spin on the headline. Getting kinda tired of this drug. No PTA improvements and no durable word scores. It’s ridiculous when compared to the hype when this all started.

Great news, and then this in the middle of the press release: “Of the five subjects that had a statistically significant response at day-90, the four that returned for evaluation had scores that remained above their baseline word recognition measures, though were below the threshold for...

Adding to this: Anthony Ricci. He’s also from the Stanford Initiative to Cure Hearing Loss. He specializes in hearing on the cellular level. Him and Jackler would be a nice combo.

Interesting indeed. Apparently they can now take a look at human cochleas and hair cells in people undergoing brain tumor surgery (37:10).

Or cake with copium.

What still concerns me is the low response rate (around 35% in Phase 1/2) and that the presbycusis trial showed no statistical significant improvements, including word scores. Sure, these were older patients, but no statistical significant improvement at all...? I’m afraid Frequency Therapeutics...

Their own press release said they saw no improvement in ultra high frequencies in Phase 2a...

I would take garlic pills, Himalaya kiwi’s or breast milk if it had any chance of improving my crappy hearing, that doesn’t make those things any more effective.

I’ve read this thread marginally since FX-322 failed in Phase 2a, but where did this OHC/IHC thing come from? Has it actually been confirmed this is the reason why in Phase 1/2 audiograms didn’t show any results, but WR scores did (well, for 65% of patients the drug didn’t do anything for...

The ultra high frequencies were already measured in Phase 2a. FX-322 didn’t do anything.

FX-322, a word score drug - even in the best case scenario - will not supplant hearing aids or cochlear implants in any way. You will always need hearing aids to benefit from increased word scores because of the amplification required. I also don’t think FX-322 will influence the kind of hearing...

10% improvement in WR scores only in 34% of patients. Nothing for the audiogram. It’s true current treatments for hearing loss don’t treat the condition at all, but FX-322 is not the game changer it was made out to be.

The results of the Phase 1/2 trial are due early 2021, right? I’m very curious what the results will be.

I don’t think any type of technology can take away the fundamental drawbacks of intratympanic drug delivery. Those drawbacks have been well documented. It’s unreliable, unpredictable and has a very hard time getting drugs beyond the ultra high frequencies. The major reason most otologic...

1. I wasn’t wearing a hearing aid at the time, so I didn’t notice any improvement. I only got a hearing aid when the WR score stabilized. The thing with WR scores is that it doesn’t mean anything without loudness. My 64% WR is at 90 dB I believe. At 70 dB it’s much lower. My PTA is around 70-75...

I’m not writing off the IHC regeneration theory entirely. We see strange things in patients with sudden hearing loss. The audiogram doesn’t improve, but the WR score does. I myself went from 0% WR to 64% in 6 months. The audiogram/PTA? Unchanged. My doctor says the brain adapts.

If they really believe the grass analogy they should go back to multiple dosing with a new schedule at some point.

Wasn’t there also one responder who went down in WR in the follow up? How is that possible if IHC regeneration is the cause for these improvements? The hair cells are either there or they aren’t there. I find it hard to believe they would die off after 6-12 months.

Am I the only who would really appreciate a podcast with the likes of Robert Jackler of Stanford or Zheng-Yi Chen of Harvard? Where are we with hearing loss and tinnitus research? What hurdles do we need to overcome to get treatments to patients? What can we realistically expect from future...

There was, in the first trial. There was a low dose and a high dose. Both were deemed safe, they stuck with the high dose since then. https://clinicaltrials.gov/ct2/show/NCT03616223