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CBS ran the report. Not Frequency Therapeutics.

Sounds like the hyperacusis I had for a long time. But I think the better term is "recruitment." Basically what's happening is you've got some damaged sound receptive cells in your cochlea, and they're sending signals incorrectly to your brain. For me, it was speakerphones, small electronic...

It may or may not need a Phase 3. Depends on if Phase 2b meets endpoints, and FDA says a Phase 3 is needed. By now, almost 300 patients have received FX-322. That's enough safety and adverse effect data for the FDA to decide if one is needed. Note: They're still on-track for a Breakthrough...

The FDA is specific on approving a drug to be sold in the US: 1. Favorable safety profile (low risk, or well-defined risks). 2. Specific target conditions the drug intends to treat. 3. Specific patient population that can see reliable benefits. IMO: Frequency Therapeutics has made the case to...

This honestly seems about right in terms of sale price. Consider what an asset pricing sheet for the patents / know-how would look like. They have zero projected return, since no market value was established. And, since the work is incomplete because they're selling mid-trial, more...

They received a grant from the DoD prior to the FX-322 Phase 1/2.

Today is my 4th anniversary of acquiring intrusive T and H. To those of you that are new and still struggling to cope... it gets easier.

It depends, but until a few million people have sampled the drug in their ears, one can only speculate. I suspect genetic conditions play a factor too. Me, my sister, brother, and father all started experiencing some level of tinnitus / hearing loss in our 30s. Stands to reason that 25-30 years...

It should be noted that the drug cannot provide a permanent gain, either. It has demonstrated that to some extent it is causing the regeneration of original hair cells or hair-like cells. The original cells we are born with aren't permanently durable, and neither will be the regenerated cells...

He wouldn't have been allowed into the trial (assuming Phase 1/2 based on the description in the video) unless he had demonstrated that his hearing loss was 'stable' at entry. So, his doctor would have had to show to the trial managers that he hasn't improved naturally or by any other means over...

I wonder if he was patient 937 from the Phase 1/2?

If the OTO-413 trial demonstrated more convincing positive outcomes, they would certainly not have gone down the same path. They would have options to continue to fund development that they don't have today. It's possible they would have considered an acquisition prior to a successful OTO-413...

It's unknown. So just saying "multiple doses didn't work" is misleading. And FREQ hasn't bothered investigating timing of the dosing, or any other alternative routes. They have discussed "multiple single doses" in the past, which might hint that the redosing happens significantly apart, where...

Not likely. Their research is positioned to activate progenitor cells throughout the body. After focusing on the ear with FX-322 / FX-345, they're working on applying the same for cells relating to MS.

The Phase 2a with 0.3 mg had favorable outcomes. It was the high dose cohort evaluation (0.75 mg + 1.5 mg) that did not show improvement. This is why they are evaluating how to proceed with OTO-413. They could proceed with a Phase 3 trial designed around the 0.3 mg dose. They also note having a...

If the Phase 2B produces positive results, they’ll most likely stick with the trial design in Phase 3. They’re more focused on word score deficit, than high frequency audiograms. Most likely, it seems as though differentiation of certain syllables (fricatives) that exist well above 8 kHz...

Wonder if the higher doses overdid it like the multi-dose FX-322. Anyways.

Looks like they over-recruited. Hoping that's a good sign for data outputs.

You're right. It is... so could be any time.

Start of Q4, 2022.

Secondary outcomes of the current FX-322 Phase 2B should inform the decision on the question of "Do patients actually get helped." or "Does their quality of life improve in a meaningful way?" Aside from the primary endpoint, which will need to be both CLINICALLY and STATISTICALLY significant...

Learning how to properly insert a foam earplug goes a long way. Back when I did go to the range, I'd say 50%+ of the people wearing earplugs didn't have them properly inserted. Same with construction jobs, easily half were deep enough given the loudness of the work.

We have to remember that these companies first and foremost live and die by the success of their trials. So designing a good trial is really critical to getting a drug to approval. A major goal determining a clinical trial's success is the ability to control inputs by reducing variables that...

The implication has been that inner hair cells are regenerating, but possibly not (or not enough) outer hair cells. This would explain the word score improvement and WIN improvements, but not audiogram improvements.

It does happen. Firms sell IP to larger entities (corporations, universities, governments) that have the resources to re-trial / re-formulate / re-study.

Fed rate hikes have little to do with their cash on hand. Inflation will cause them to burn more quickly in the short term. And frankly, there is no long term for Otonomy if their trials don't succeed.

Frequency Therapeutics released evidence of suppressed word recognition scores used by patients to gain acceptance into the FX-322 Phase 2A. Which resulted in really abnormal measurements in the placebo group (and drug group). They remedied that with an elongated lead-in period with additional...

Not to be an ahole about it... but OTO-313 was never for the chronic cases that most of us have been living with for years and years. It was a treatment to mitigate the damage occurring in brand new cases that becomes permanent. Anyone on here with tinnitus for over a year is already basically...

I'm going to quote one passage from the recent press release: "These results were unexpected with a much higher placebo response than observed in the prior Phase 1/2 study,” said David A. Weber, Ph.D. Frequency Therapeutics said the exact same thing with their Phase 2A failure with regards to...

It's way higher than 3400 Hz. Take a look at the speech banana: Fricative sounds: F, TH, S, are highly used in English are produced north of 4000 Hz. Differentiating those fricative sounds from each other actually occurs in the ultra-high bands (per Chad's research), and differentiating them...

Now that the trial is over and dead, and although I was one of the members here protesting you talking about your experience during trial, it would be nice to know if you got the drug or not.

This would be a good time for Astellas to buy them. Astellas seems eager to get into the hearing space. Even if OTO-413 Phase 2+ looks good, it's still at a a discount.

Weber's comments re: Placebo sound eerily similar to the FX-322 Phase 2A comments from Lucchino.

It's called a "Future State."

Patient: Complaint of tinnitus following loud noise exposure. Doctor: Administers OTO-313 to get tinnitus under control and reduce long-term damage / likelihood of long-term tinnitus. HIGHLY likely that hearing is damaged to some degree. Sets follow-up at 6-months. Patient: Returns at...

It depends by the term "better." Based on this site, and on those who joined due to a noise injury, in the short-term (let's call that a year), it appears to be a combination of inflammation reducing and habituation. In the long-term, again, based on the long-haulers on this site, tinnitus does...

Classic observations of the brain by researchers of tinnitus patients have led to this conclusion. It's the "best" explanation provided thus far, especially with tinnitus where progression of the disorder is a one-way street — it only gets worse. What's interesting is that neurological...

It sure is, but it does improve with time. It's like your ears start to get more "tolerant" of some noise exposure, but it never goes back to the way it was, so caution and knowing your limits is important. Note your exposure times to loud environments. Also, keep earplugs handy when in loud...

Whenever you feel it’s too loud. I spiked easily at first, over time, you can go to moderately noisy restaurants at lunch. Bars, maybe not. But for most things like that, get a set of custom molded earplugs. Most people don’t even know you have them on, or don’t care.

Earplugs. That's it... I travel for work, I travel for vacation. Earplugs.

It's not well understood. You can't quite point to the exclusion criteria in the trial to know for sure; that criteria is to ensure the trial participants are reliable in placebo effect / drug response.

That's what's interesting about FX-322 / Progenitor Cell Activation. In vitro, Frequency has observed the output of PCA where a new daughter cell (hair cell) is create with a nerve. While it cannot be observed in vivo in the cochlea, they have observed a signal via improvements in word...

This comment describes what should be known as the “Tinnitus Talk Paradox”... 1. A claim where ENTs have academic training, years of experience, and don’t know shit about things like tinnitus. Yet, are a reliable source of research in the space. 2. Anecdotes from a “researcher” broadly defines...

I don't see it as something that is "worrying"... I see it as scientific discovery happening in real-time, and in front of the public. This is probably why we see so many dissenting opinions here, because it isn't something the general public is all that familiar with. The FDA advised Frequency...

201-1 = (Phase 1/2) SSNHL and NIHL Study Mild-Moderately Severe [18-65 y/o] 201-2 = Phase 1/2 Durability (Long term study) 111 = Study of Administration Conditions - All Etiologies, Mild-Severe [18-65 y/o] 112 = Age-Related Hearing Loss Study - Mild-Moderately Severe [66-85 y/o] 113 = Severe...

They did test with the extended high frequency in the Phase 1Bs and 2A. However, didn't see anything meaningful. The Phase 2A data was trashed by patient bias, and a loose entry threshold, so there isn't much to say about the Phase 2A. As for all of the varying Phase 1B outcomes, the underlying...

The difference is that bird/reptilian/amphibian progenitors can still be signaled by the body to "turn on" and complete mitosis. Mammals lack the ability to signal the progenitor cells in the cochlea when needed, but the functionality is still there. This is what FX-322 is trying to do. Note...

No. I think either FX-345 OR FX-322 could be complimentary to OTO-413. The drugs address exclusive underlying conditions of Acquired SNHL.

FX-322, FX-345, or OTO-413 could help you individually or in combination. It's too early for anyone on this forum to give you a definite answer.

The majority of hearing loss patients have acquired (Noise, SNHL) losses that are between mild and moderate. Severe or profound makes up the furthest edge of the hearing loss population. In the bulk of the mild-moderate cases, there is a combination of hair cell damage of varying levels...

No, probably not. No, probably not.

I suspect it was because the entire 15k hair cells weren't restored. So, the new ones are there, but existing hair cells deeper in the cochlea that still are aged/damage still continued to wear, causing a loss in hearing. Or, the regenerated hair cells just aren't as good/complete as the...

I still don't get how OTO-6XX is intended to cause damaged cells to repair themselves. FX-322 activating progenitors isn't exactly new science, and cells are running native programs to begin with. Same with OTO-413, there is BDNF at higher levels in utero, so introducing cause a similar effect...

Sounds to me that OTO-6XX is a long, long ways away.

Application takes time with FDA, setting up trial sites takes time, staff limitations to manage more than 1 trial.

Let's keep in mind that not being tested in the Clinical Trial doesn't mean that the company doesn't think it will help. The exclusion/inclusion criteria in all of these trials is to ensure the company has a reliable/measurable/well understood population of patients to collect data from on their...