Frequency Therapeutics — Hearing Loss Regeneration

[FGG]

Eh, above a certain point, fighting age related hearing loss is pointless. I can imagine FX-322 only being given out to children/teenagers only in the cases of extreme damage/tinnitus.

This seems like a dystopian hyper-utilitarian society take on this to me.

 

[WillBeNimble]

Woah, that comment blew up. Maybe it was the lack of a clear definition on what I meant?

So, no healthcare plan is going to pay for preserving the high frequency bands, like 16 kHz and above. That's the "beyond a certain point" if we're talking like the age related hearing loss on the 3.5 kHz to 10 kHz range, sure, maybe they (the healthcare plans) might help and we should be doing something there once FX-322 gets out, but that's who this treatment has been aimed at this whole time. That's not an untapped market, like d'Wooluf mentioned. As for only treating kids and teenagers if there was damage, yeah, that makes sense. We don't monitor their leg bones to ensure they won't break them. That's what I interpreted d'Wooluf's statement as, trying to keep hearing pristine for teenagers through life. Hence, the above a certain point.

Also, yes, I am quiet familiar with the quality of life improvements restored hearing would bring to those with age related hearing loss or just general hearing loss.

I think the misunderstanding is that the term Presbycusis covers all age related hearing loss, even the upper high frequency bands, which is what I was saying is unlikely to be treated, and you're all interpreting it as the main band of up to 8 kHz.

 

[WillBeNimble]

This seems like a dystopian hyper-utilitarian society take on this to me.

Well, this is the American healthcare system I'm talking about. /Jk

To be clear, we should be treating those with hearing loss on main bands and a bit above who are adults too. The statement I made was looking at the comment I was responding to as mentioning we could prevent loss of hf bands and keep hearing pristine through life. Hence the "above a certain point" and the mention of treating children/teens in only cases of extreme damage or cases of tinnitus.

I am not, nor ever would I, advocate that we don't treat those we could benefit the lives of if this came out. I am saying that we can't expect us to start dosing teens and kids with this drug to preserve the full spectrum of hearing up to 20 kHz.

 

[FGG]

Woah, that comment blew up. Maybe it was the lack of a clear definition on what I meant?

So, no healthcare plan is going to pay for preserving the high frequency bands, like 16 kHz and above. That's the "beyond a certain point" if we're talking like the age related hearing loss on the 3.5 kHz to 10 kHz range, sure, maybe they (the healthcare plans) might help and we should be doing something there once FX-322 gets out, but that's who this treatment has been aimed at this whole time. That's not an untapped market, like d'Wooluf mentioned. As for only treating kids and teenagers if there was damage, yeah, that makes sense. We don't monitor their leg bones to ensure they won't break them. That's what I interpreted d'Wooluf's statement as, trying to keep hearing pristine for teenagers through life. Hence, the above a certain point.

Also, yes, I am quiet familiar with the quality of life improvements restored hearing would bring to those with age related hearing loss or just general hearing loss.

I think the misunderstanding is that the term Presbycusis covers all age related hearing loss, even the upper high frequency bands, which is what I was saying is unlikely to be treated, and you're all interpreting it as the main band of up to 8 kHz.

Ah. You were talking about health insurance coverage. They already don't cover hearing aids so this is probably true. I would bet on an out of pocket cost for treatment as well.

 

[WillBeNimble]

Ah. You were talking about health insurance coverage. They already don't cover hearing aids so this is probably true. I would bet on an out of pocket cost for treatment as well.

Yeah, that's the angle I was kind of taking with it. As for them paying, I hope they'd cover it in the future, considering they'd cover a steroid injection, but they're not likely to jump on for covering a bi-yearly injection to preserve all the high frequency bands.

Assuming we see improvement on the high frequency bands from FX-322, and in speech in noise results, I could see the high frequency bands taken a bit more seriously, but at some point the benefit probably tapers off.

 

[Diesel]

Ah. You were talking about health insurance coverage. They already don't cover hearing aids so this is probably true. I would bet on an out of pocket cost for treatment as well.

It's going to depend on the long-term advantage that FX-322 provides, and the cost. Insurance companies like 1-and-done procedures that reduce future risk return.

We know from the Phase 1/2 that FX-322 improves certain clinical aspects of hearing (word score, WIN, Pure tone). And, we know from Frequency that the hair cells seem to be durable; as the benefit received from the Phase 1/2 has generally been retained up to 1-2 years later. Hopefully that means treatment won't be required that often (if people take care of their hearing!).

Insurance providers look at hearing aids and know that they'll be on the hook for continually replacing them for years; which is probably not profitable. Especially as hearing degenerates and more expensive hearing aids are needed as patient hearing quality declines. More so, an adjuster may also consider the cost of ongoing ENT care and anti-depressant costs as a "lesser of two evils" compared to covering hearing aids. Also, Quality-of-life measures do not seem to improve substantially when elective/prosthetic treatments are applied; so this is probably the case with hearing aids. Insurers want QOL to improve so they don't have to keep pouring money into a problem that doesn't help you, and can keep collecting your insurance payment. Boosts that bottom-line.

Insurance companies may look at FX-322 as a preferable option (depending on cost) if it helps them avoid increasing hearing-aid costs. Also, if the Phase 2A shows significant improvements in QOL, an adjuster will be able to use that data to determine how much an insured population won't need additional treatments after FX-322. QOL improvements also may mean less money on the hook for anti-depressants, therapy, return ENT/audiologist visits, and other co-morbidities associated with hearing loss.

There are also other scenarios to consider here with insurance. In a post-FX-322 world. Insurers may require patients first receive FX-322 before applying or being approved for hearing aids in the case of certain diagnosis; or for reimbursement.

It's also not out of the realm of possibility for health insurers to begin offering an add-on hearing programs similar to dental/vision; if FX-322 is reasonably priced. A larger, younger, working population paying a few dollars per pay would create enough cash-flow to cover a hearing-specific maintenance program. I would imagine we'll see more of this during the end of the Phase 3.

 

[UHPTS]

In 5+ years when this or other such drug hits the market the world, thanks to advancement of technologies, will be so profoundly different that worrying now about whether the insurance will cover the drug is pure entertaining pastime pleasure speculation.

 

[Koz]

I haven't kept up with this thread much for the last month or so.

Has there been any indication when phase II results are out?

 

[mrbrightside614]

I wonder if any patients in the current clinical trials have disclosed and stated that they have hyperacusis and which type? They could ask the current and previous patients if they have noticed any improvements in their hyperacusis. There is bound to be at least a few patients that suffer from hyperacusis.

Doubtful. I assume the cohort studied with such "stable hearing loss" would probably have next to no hyperacusis, and even if they did, I doubt it'd be documented.

Eh, above a certain point, fighting age related hearing loss is pointless. I can imagine FX-322 only being given out to children/teenagers only in the cases of extreme damage/tinnitus.

I see your point only insofar as age-related hearing loss is probably due to poor circulation and a higher likelihood of flattened epithelium, but I don't think you can outright write this drug off on any front right now.

Edit: if Frequency manages to distinguish that "hidden hearing loss" is the fault of lost UHF-associated hair cells and not cochlear synaptopathy, in my estimation this therapy would emerge as the first-line treatment in combating hearing regeneration of all frequencies and ages.

Is what you describe as phase 4 a release into the market or is it another trial?

Alas as always it might fail which I hope it does not. Now having said that there does seem to be a lot of promise from the drug thus far however.

Both of those things are two different things.

I believe Breakthrough Status means that the drug is for a significant condition which no available medication exists. Essentially they have to prove that they have performance results which are statistically significant according to the criteria.

They're nowhere near there yet, however if the positive progress continues and they obtain similar and better outcomes to what they got behind them now then they will surely satisfy this outcome.

Keep in mind they said they are open to revisiting their compassionate use policy which would bypass every jargon hurdle to release.

 

[Paulmanlike]

Has there been any indication when phase II results are out?

September 30th I think?

 

[FGG]

Edit: if Frequency manages to distinguish that "hidden hearing loss" is the fault of lost UHF-associated hair cells and not cochlear synaptopathy, in my estimation this therapy would emerge as the first-line treatment in combating hearing regeneration of all frequencies and ages.

He did say on the podcast that he thought hidden hearing loss was probably due to both UHF hearing loss and cochlear synaptopathy.

 

[WillBeNimble]

I see your point only insofar as age-related hearing loss is probably due to poor circulation and a higher likelihood of flattened epithelium, but I don't think you can outright write this drug off on any front right now.

Edit: if Frequency manages to distinguish that "hidden hearing loss" is the fault of lost UHF-associated hair cells and not cochlear synaptopathy, in my estimation this therapy would emerge as the first-line treatment in combating hearing regeneration of all frequencies and ages.

So, not writing the drug off. In fact, I really hope it surprises us all, and it shows that it can coax upper frequencies back to life as well by some luck. Then it could help everyone, regardless of tinnitus tone. Leave no Tinny behind.

Also, I would agree, that if UHF loss is seen as the issue for hidden hearing loss, than I could see this being brought out as a way to help. I imagine as is, and with the expected work with it, it will be the first line treatment for a lot of things once it comes out. Sudden hearing loss? Here's steroids and after FX-322. Recent tinnitus? Here's FX-322. Hyperacusis? Here's FX-322, we don't know for certain if it will help, but here's off label.

 

[Lucifer]

So, not writing the drug off. In fact, I really hope it surprises us all, and it shows that it can coax upper frequencies back to life as well by some luck. Then it could help everyone, regardless of tinnitus tone. Leave no Tinny behind.

Also, I would agree, that if UHF loss is seen as the issue for hidden hearing loss, than I could see this being brought out as a way to help. I imagine as is, and with the expected work with it, it will be the first line treatment for a lot of things once it comes out. Sudden hearing loss? Here's steroids and after FX-322. Recent tinnitus? Here's FX-322. Hyperacusis? Here's FX-322, we don't know for certain if it will help, but here's off label.

I hope we find out more about what hair cell regeneration treats and what fixing synapses treat.

 

[lymebite]

Adding my thanks to @Hazel, @Markku, @mrbrightside614, @FGG, and @Autumnly for the outstanding interview with Carl LeBel. Special appreciation for the transcript, which for me provides accessibility to the interview as I am unable to listen to the podcast due to severe hyperacusis.

Would be great to see everyone posting in this Frequency Therapeutics thread to have the yellow "Podcast Patron" badge next to their name. It costs as little as $2 a month. The time devoted by the volunteers making these podcasts happen is priceless, but we as Tinnitus Talk members can at least help defray their expenses by becoming Podcast Patrons.

If you go to this link and sign up, you will soon see the coveted yellow "Podcast Patron" added to your Tinnitus Talk profile:

https://www.patreon.com/TinnitusTalk

 

[WillBeNimble]

I hope we find out more about what hair cell regeneration treats and what fixing synapses treat.

We will with this and OTO-413, I'm sure of it. We'll have some idea of how both affect hearing at the end of the year.

My concern is that this treats those with lower high frequency tinnitus, but those with higher tinnitus, like 16 kHz and above, get left out due to flat epithelials. As once you solve the relatively acute phase of tinnitus, you don't need the ion channel pills to reset the system anymore, nor look at other methods of regeneration. Funding for these other methods decreasing worries me.

 

[WickedCarnival]

Frequency Therapeutics Announces $42 Million Private Placement

WOBURN, Mass.--(BUSINESS WIRE)--Jul. 17, 2020-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced that it has agreed to sell 2,350,108 shares of its common stock in a private placement to institutional and accredited investors. Institutional investors in the private placement included Wasatch Global, Federated Hermes Kaufmann Funds, RTW Investments, Perceptive Advisors, Driehaus Capital Management, Maven Investment Partners US and Alexandria Venture Investments, in addition to other new and existing investors. The transaction is expected to result in gross proceeds to the Company of approximately $42.3 million, based on a price of $18.00 per share, before deducting placement agent fees and other expenses. The closing of the private placement is subject to customary closing conditions and is expected to occur on July 20, 2020.

The Company plans to use the net proceeds from the private placement to further advance the clinical development of FX-322, its lead product candidate in Phase 2a development for sensorineural hearing loss, by gaining additional insights regarding the patient populations and severity of hearing loss that FX-322 may treat. The Company also plans to increase support for its remyelination program in multiple sclerosis, which it intends to move into the clinic in the second half of 2021, and new areas of research where there is potential to utilize the Company's progenitor cell activation platform.

Cowen and Company, LLC served as the placement agent for the private placement.

"We are very pleased with recent clinical advances demonstrating both delivery of FX-322 to the site of action within the cochlea and the durable hearing response seen in patients from our Phase 1/2 study. This additional investment will further support our ongoing FX-322 development efforts to bring a potential disease modifying therapeutic forward to the millions of individuals suffering from hearing loss, and apply our regenerative medicine platform to other serious degenerative diseases including our remyelination work in multiple sclerosis," said David L. Lucchino, Chief Executive Officer of Frequency Therapeutics.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the Securities Act), or applicable state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities being issued in the private placement may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

 

[FGG]

We will with this and OTO-413, I'm sure of it. We'll have some idea of how both affect hearing at the end of the year.

My concern is that this treats those with lower high frequency tinnitus, but those with higher tinnitus, like 16 kHz and above, get left out due to flat epithelials. As once you solve the relatively acute phase of tinnitus, you don't need the ion channel pills to reset the system anymore, nor look at other methods of regeneration. Funding for these other methods decreasing worries me.

The frequency of hearing loss does not determine the degradation of the epithelial cells. It's the degree of hearing loss (90 dB and greater).

 

[Thuan]

Does anyone have research articles on FX-322's pre-clinical research data?

Everyone talks as if FX-322 is the next miracle drug but from what I read and searched, it's just their claims without evidence (i.e. hard data).

Perhaps I'm just not searching hard enough.

 

[WillBeNimble]

The frequency of hearing loss does not determine the degradation of the epithelial cells. It's the degree of hearing loss (90 dB and greater).

True, but hearing loss is seen at the higher frequencies first, right? So considering we get hearing loss on the higher frequencies first, it would make sense that we might be unlucky enough to lose our hearing on the range of our tinnitus if it's high enough.

 

[FGG]

Does anyone have research articles on FX-322's pre-clinical research data?

Everyone talks as if FX-322 is the next miracle drug but from what I read and searched, it's just their claims without evidence (i.e. hard data).

Perhaps I'm just not searching hard enough.

You don't need the pre-clinical results, they have clinical results. But they published pre-clinical results in Cell among other journals.

They also talk about their results in detail in both of these webcasts:

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

Looks like the Fireside chat is even back up.

 

[HootOwl]

Does anyone have research articles on FX-322's pre-clinical research data?

From their website:
https://www.frequencytx.com/science/publications/

 

[FGG]

True, but hearing loss is seen at the higher frequencies first, right? So considering we get hearing loss on the higher frequencies first, it would make sense that we might be unlucky enough to lose our hearing on the range of our tinnitus if it's high enough.

You could get an extended audiogram and check.

 

[FGG]

Since results get asked about a lot, this document is probably the single best place to get Phase 1 results all in one place:

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

 

[Thuan]

From their website:
https://www.frequencytx.com/science/publications/

Thanks, I can't believe I missed these.

 

[Enclave]

​

The time has finally come!

Today we are publishing perhaps our most long-awaited episode of the Tinnitus Talk Podcast. It's also an episode that has cost us more time and resources than ever. After exchanging many dozens of emails with the company, preparing our questions diligently, making all the technical arrangements for recording from three (!) locations simultaneously, and many days of editing and transcribing, we are proud to finally present the community with the results of our hard work.

As show of appreciation for those who support the Tinnitus Talk Podcast financially, allowing us to cover our expenses and maintain high quality standards, only Patreon supporters will get access for now. But don't worry, we will make it freely available for everyone else in a week or so!

Listen to the interview

I watched @Hazel's video and all I saw was a privileged white person being a gatekeeper of the most important information this forum has to offer.

There are other ways to do fundraising that don't resort to censoring information for those who have limited to no financial resources. Tinnitus and hearing loss is a debilitating disease and it has been well documented that individuals who suffer from these ailments experience socioeconomic disadvantages like unemployment, reduced pay, or stunted career growth.

Hazel and the rest of the moderators should be ashamed of themselves. Free the information for the people and stop censoring content. The moderators should be ethical and post the podcast today for everyone.

 

[Hazel]

I watched @Hazel's video and all I saw was a privileged white person being a gatekeeper of the most important information this forum has to offer.

There are other ways to do fundraising that don't resort to censoring information for those who have limited to no financial resources. Tinnitus and hearing loss is a debilitating disease and it has been well documented that individuals who suffer from these ailments experience socioeconomic disadvantages like unemployment, reduced pay, or stunted career growth.

Hazel and the rest of the moderators should be ashamed of themselves. Free the information for the people and stop censoring content. The moderators should be ethical and post the podcast today for everyone.

Hi there, sorry to hear you feel this way. But if you watched my video, you would have also heard me say that if you can't afford to support us and want immediate access, just contact us directly. We will in such cases give access, no questions asked. [Of course, that doesn't apply to people who approach us aggressively.]

And in any case, I don't see how waiting one week to publish publicly is the equivalent of "censorship." You might want to look up that word in the dictionary. We were merely trying to show our appreciation for those who (sometimes in spite of living on limited means) support us. And everyone else will get access in just a few days, or sooner if they really need it. How does that hurt anyone?

I might be a privileged white person, but it's very hurtful to be called "unethical" when @Markku and I have worked literally thousands of unpaid hours over the years for this community. You don't know anything about our personal circumstances, but you seem to (mistakenly) assume we are swimming in money. I personally have spent many thousands of euros out of my own pocket to cover Tinnitus Talk expenses. Is it unethical to want to recoup some of those costs? Do you truly expect that from us? And do you expect us to keep doing this work without any form of support, financial or moral, while incurring aggressive attacks from people like yourself?

We understand that a lot of people in this community have limited means. We don't expect everyone to contribute financially, only those who value our work and who can afford it. And we are making the content freely available very soon, as promised. I really don't see how we can make it any fairer than that.

 

[Lucifer]

I watched @Hazel's video and all I saw was a privileged white person being a gatekeeper of the most important information this forum has to offer.

There are other ways to do fundraising that don't resort to censoring information for those who have limited to no financial resources. Tinnitus and hearing loss is a debilitating disease and it has been well documented that individuals who suffer from these ailments experience socioeconomic disadvantages like unemployment, reduced pay, or stunted career growth.

Hazel and the rest of the moderators should be ashamed of themselves. Free the information for the people and stop censoring content. The moderators should be ethical and post the podcast today for everyone.

I am astonished @Enclave that you use the "white privilege card" as your reasoning why they should release the podcast for everyone.

A person race has nothing to do with why they decided to not release the podcast for everyone to see except for Podcast Patreon. I can't believe you even mention "white privilege" at all. I'm ashamed @Enclave that you had to resort to that type of behaviour.

I think @Hazel and the others don't deserve the hate.

They said they will post it a week later for everyone to see.

The reason why they decided to release it for those who have signed up for Patreon as it would have cost them money for the equipment to record the podcast and also time spent editing as well. I wouldn't be surprised if they had to pay Carl Lebel to get him to do the interview.

There are costs in doing this interview which you didn't seem to account for @Enclave

I think you should apologise to @Hazel, @Markku and the moderators you decided to bash on stating the "white privilege card".

 

[Jurger]

Great to see this thread becoming another place where slinging "you're white" somehow becomes a valid argument for everything.

 

[Lucifer]

 

[Jaysterk]

I watched @Hazel's video and all I saw was a privileged white person being a gatekeeper of the most important information this forum has to offer.

There are other ways to do fundraising that don't resort to censoring information for those who have limited to no financial resources. Tinnitus and hearing loss is a debilitating disease and it has been well documented that individuals who suffer from these ailments experience socioeconomic disadvantages like unemployment, reduced pay, or stunted career growth.

Hazel and the rest of the moderators should be ashamed of themselves. Free the information for the people and stop censoring content. The moderators should be ethical and post the podcast today for everyone.

What a joke. Never thought I'd see a claim of "white privilege" come up on a tinnitus forum. Enclave just took the prize for posting the stupidest thing I've read all week.

@Hazel, thanks for making the interview possible.