The sooner the better for any discovery that regenerates damaged or destroyed hair cells. I pray TOMORROW is TODAY for a viable cure for us all. It's time well overdue.
Frequency Therapeutics — Hearing Loss Regeneration
- Thread starter RB2014
- Start date
Member- Jan 16, 2020
- 436
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
Back when I was in the acute phase (early onset) I used to go for a walk around this fountain in the hospital garden. The sound of the water gently splashing I found very easy on my ears. Fast forward a few months to when I had figured out how to use the internet (early nineties and it was a new thing). I can recall Dr. Nagler offered free TRT treatment for one patient. Curiously this one patient who won the offer was the complete opposite to myself. He literally (according to his posts) could not stand the sound of water. Contrast that with me -- and you might laugh at this, but the first relief of the day was when I got up in the morning to pee. No joke. I found the sound of water very soothing. He was the opposite.
I concluded that there must be a lot of psychology involved in hyperacusis.
Great if it could all be related to the Cochlea and its components.
The only comparison I can think of is hearing aids, so if blinding has anything to do with reporting results this will obviously not be an option.
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
Are you able to post the full-length article? I can't access it because of the paywall
From the excerpt, it seems a little pessimistic. Frequency Therapeutics and co were basically only founded 5 years ago and then they have to go through a good few years at least of preclinical development and drug discovery before starting human trials. Now phase 1/2 has been completed, demonstrating safety and also showing promise for efficacy. Of course we shouldn't be celebrating prematurely but very real progress has been made. Not to mention the Regain's project efforts across the pond.
- Sep 21, 2016
- 1,051
- Tinnitus Since
- 2011 - T, 2016- H, relapsed 2019
- Cause of Tinnitus
- noise-induced
Yup, it's a strange one - the general assumption seems to be that hyperacusis sufferers simply can't cope with noises above a certain decibel level but everyone seems to have their own individual triggers which aren't necessarily related to decibel level. For me, I seem to have the biggest issues with laptop/phone speakers when I'm in a spike - I speculate it could be something to do with the frequency or compression but that seems to aggravate my ears the most even at a low volume. It could also be psychological as well.
I think it's more likely you didn't have as much or any hyperacusis in the splashing water frequencies. I doubt the other person just decided to not like the sound of water.
HootOwl
Member
The article tells us nothing new. In fact it's a bit of a weird piece. You would think with such a clickbait title they would have many comments made by many researchers and otologists to back it up but instead they got a single surgeon to say "we should be cautious about saying a cure is 5 years away." But meh clickbait is clickbait. And even this guys comment doesn't read as doom and gloom. It reads as a medical professional who doesn't want to promise the moon because it could get them into trouble which is perfectly understandable.Are you able to post the full-length article? I can't access it because of the paywall
From the excerpt, it seems a little pessimistic. Frequency Therapeutics and co were basically only founded 5 years ago and then they have to go through a good few years at least of preclinical development and drug discovery before starting human trials. Now phase 1/2 has been completed, demonstrating safety and also showing promise for efficacy. Of course we shouldn't be celebrating prematurely but very real progress has been made. Not to mention the Regain's project efforts across the pond.
I think most people on this forum are so plugged into the research that we understand what FX will and won't fix, as well as their current limitations but others are probably not so informed hence maybe the article to curb the idea that in 5 years every single case of hearing loss will be fixed.
(Although based on what Chen and Decibel are doing - Chen for flattened epithelium and Decibel for supporting cells - I honestly think we will hit pretty damn close in 10-15 years time but that's just my own pleb opinion).
Decibels progress is the only one I would consider slow. Frequency definitely not, they've been zooming through the process if you look at their timeline.
But if you open your PMs I can send you the full article
ajc
Member
- Feb 6, 2018
- 1,170
- Tinnitus Since
- 11/2002; spike 2009; worse 2017-18
- Cause of Tinnitus
- Loud music - noise damage
Boston area startups making slow progress in fight against hearing lossAre you able to post the full-length article? I can't access it because of the paywall
When a small cluster of biotechs working on drugs for hearing loss cropped up in the Boston area several years ago, it raised the hopes of legions of mostly older people who rely on hearing aids or implanted electronic devices.
Since then, investors have poured hundreds of millions of dollars into those local startups. The young companies have snapped up top scientists and genetic experts from Harvard, MIT, and Massachusetts Eye and Ear. And Greater Boston has emerged as the hub of hearing restoration efforts.
All the elements are in place for a breakthrough. But therapies to regenerate lost hearing — rather than simply amplify sound — still may be years away.
It's the classic biotech conundrum, familiar to those targeting hard-to-treat diseases ranging from cancers to dementia. Even with big demand, high hopes, and ample funding, the hurdles remain formidable. And the scientific and regulatory journeys almost always take longer than anticipated.
"People think a drug could be ready in about five years," said Dr. Bradley Welling, a neurotologic surgeon at Mass. Eye and Ear who tracks the research closely. He said he sees genuine progress but, almost apologetically, added a cautionary note: "That's what they also said five years ago."
Early-stage research and clinical trials have shown encouraging signs, along with some stumbles. But after false starts and experimentation, three of the largest biotech players — Frequency Therapeutics, Decibel Therapeutics, and Akouos — have settled on approaches they think offer the best hope to restore lost hearing: gene therapy and regenerative medicine. They're also among the most scientifically challenging approaches.
"We see this as a new mode of medicine," said David Lucchino, chief executive of Woburn-based Frequency, which uses technology discovered by noted Cambridge scientists Robert Langer and Jeffrey Karp "It's about working with the body's natural regenerative system to heal itself."
In essence, they are trying to plant in the damaged inner ear healthy genes that regulate hearing and balance or molecules that can activate dormant hair cells to regenerate hearing. The challenge is not only to develop the right formulation but also find a way to surmount what's called the blood-cochlear barrier. This protects the inner ear from toxins in the bloodstream but also makes it harder for drugs to penetrate.
There are currently only a small number of approved gene therapies on the market in the United States, including one for a rare eye disease and one for spinal muscular atrophy. Both use benign viruses known as "viral vectors" as delivery vehicles. Some of the biotechs are looking into whether this technique could also be used in the ear drum.
For many whose hearing has deteriorated, or who were born with genetic defects, the first genetic therapies can't come too soon.
"Anything to get my hearing back to a level where I can have a normal conversation would be wonderful," said retired systems analyst Mark Filteau 69, who grew up in Fitchburg but now lives in Orlando and wears hearing aids.
Drug makers are eyeing a potential market of half a billion people worldwide — an estimated three quarters of them older people struggling to talk to family or friends or to hear ringing phones or doorbells. Many are aging baby boomers who sat too close to the speakers at rock concerts, wielded jackhammers on construction sites, or worked in engine rooms or on airport runways.
"It's one of the largest unmet needs in medicine," said Manny Simons chief executive of Akouos, which recently moved 53 employees into a former art warehouse overlooking the Reserved Channel in South Boston. The company has raised $57 million to bankroll a gene therapy that would initially treat children who were born deaf but could eventually target a much broader population.
One sign of the keen investor interest is the trajectory of Frequency, one of the first hearing startups out of the gate. The company, with 55 employees, raised $84 million when it went public last fall after posting promising data from an early clinical trial. Its market value is close to $700 million.
Frequency gained wide attention last year when a small number of adults with the most common form of hearing loss showed modest improvements in hearing range and word recognition tests after a two-drug combo was injected into their ear drums in gel form. Its experimental therapy seeks to help generate hair cells in the inner ear. The company is now enrolling 96 patients in a larger trial at a dozen US sites.
Another early player, venture-backed Decibel, recently scrapped research programs exploring other approaches, laying off an unspecified number of employees. The company last week said it has narrowed its focus to regenerative medicine, initially for age-related balance disorders associated with hearing loss. It also said its founding chief executive, Steven Holtzman a biotech veteran, was retiring.
"We're committed to being a hearing loss and balance company and we're doubling down on regenerative medicine," said new Decibel chief executive Laurence Reid, who previously led Warp Drive Bio.
Decibel, based across the street from Fenway Park, has raised more than $100 million and now has 45 employees. In addition to its treatment for balance disorders, it's still working on two other drug candidates: one to prevent hearing damage in cancer patients receiving a chemotherapy, the other to improve hearing to people born with hearing loss due to a gene mutation.
Another player, Audion Therapeutics, though based in Amsterdam, conducts research in the LabCentral complex in Cambridge. It's working on a way to inhibit a protein that prevents hair cells from regenerating, using a technique developed at Mass. Eye and Ear. Other companies are working outside Boston: Swiss pharma giant Novartis has been testing a treatment, and the field has attracted a pair of West Coast startups, Otonomy of San Diego and Sound Pharmaceuticals of Seattle.
Hearing-impaired Americans who are tracking the developments believe "it's a matter of when, not if," said Barbara Kelly, executive director of the Hearing Loss Association of America, a patient advocacy group in Washington. "Science is advancing, and the future of what they'll be able to do is amazing."
But not all are certain they would try a genetic treatment.
"I might be interested in exploring a therapy," said Jack Murray, 71, a Providence retiree who started having trouble hearing high frequencies about 15 years ago and now wears hearing aids. "But I'd want to know about potential side effects before I did. I can live with what I have."
Others are living with hearing aids or cochlear implants but not always happily. Many say they increase the volume, but not the clarity of sound.
Bedford retiree Mary Drake, 75, bought her first set of hearing aids in her mid-60s. "I was in denial," she said. "My husband said, 'If the television gets any louder, the people downstairs are going to complain.'"
For Drake, who said her hearing aids have helped her but "aren't perfect," the prospect of a genetic therapy would be a no-brainer.
"I'm open to anything," she said. "I'd offer myself up as a guinea pig."
Robert Weisman can be reached at robert.weisman@globe.com. Follow him on Twitter @GlobeRobW.
WickedCarnival
Member
- Aug 16, 2018
- 68
- Tinnitus Since
- Late Autumn 2016
- Cause of Tinnitus
- Unsure between azithromycin or viral infection
I have this feeling since the day I woke up with tinnitus after taking Azithromycin. It's been a few years since then and no improvement, and I initially thought it was eustachian tube dysfunction, but I also read high frequency hearing loss can also contribute to fullness. I really don't know what to think because how does one develop ETD over just one night? Is it due to the antibiotics? Virus? I didn't have any other viral symptoms for a few weeks before or after that dreadful day I got tinnitus.
I thought the beginning of the article was not in great taste as well.
WickedCarnival
Member
- Aug 16, 2018
- 68
- Tinnitus Since
- Late Autumn 2016
- Cause of Tinnitus
- Unsure between azithromycin or viral infection
My ototoxicity was also from Azithromycin as well. I talked to one other antibiotic ototoxicity victim who also got the rice crispies. I wonder what exactly happened to our cochleas that seems different from the normal damage and gives that sensation. I don't have the crispies at all anymore but my hearing is the same.
The Boston Globe writer's profile:
"Robert Weisman reports on Baby Boomers -- their work, health, money, and lifestyle -- and life after 50. He is particularly interested in retirement and reinvention, aging, and second acts. In his 18 years at The Globe, Weisman has previously worked as a technology editor and a business writer covering high-tech and venture capital, aerospace, management issues, hospitals, health insurance, and life sciences. Before coming to The Globe, he was a business editor and writer for the Seattle Times, Hartford Courant, and New Haven Register. He is a native of Norwich, Conn., and a graduate of Boston University."
He's not exactly a biotech writer and add to that the fact that the otologist they interviewed has a research page that has nothing on regenerative medicine and it is not a primary interest of his. I wouldn't worry about this. There are definitely treatments coming within 5 years.
Or the same bird with multiple stones. Whatever the verbiage, let's stone the fuck out of these goddamn birds already.
Looks like Frequency Therapeutics is expanding the number of testing sites, and tweaking enrollment criteria slightly. Either they are trying to have a bigger sample size to show FDA or they had trouble enrolling enough people who fit their criteria:
https://www.hearinglosstreatmentrep...t-sites-plus-changes-to-eligibility-criteria/
https://www.hearinglosstreatmentrep...t-sites-plus-changes-to-eligibility-criteria/
@FGG
I understand you are considering asking FDA to give Frequency Therapeutics conditional approval for their hearing loss drug, FX-322. I'm just wondering where you stand with this? Have you had any communication with Frequency Therapeutics, specifically their regulatory people, and have they told you Frequency is willing to make this request or that they would cooperate if the request were granted?
Thanks, Tuxedo
I understand you are considering asking FDA to give Frequency Therapeutics conditional approval for their hearing loss drug, FX-322. I'm just wondering where you stand with this? Have you had any communication with Frequency Therapeutics, specifically their regulatory people, and have they told you Frequency is willing to make this request or that they would cooperate if the request were granted?
Thanks, Tuxedo
Not exactly correct. I am working on a letter outlining how serious in regards to morbidity and even mortality (in the case of suicides) tinnitus and other hearing distortions can be. I want to urge them to consider *all* drugs designed to address this in this fashion. I think naming and pushing for one particular drug (especially a publicly traded one) cheapens this. Other thoughts?
Extremely doubtful as they are actually trying to recruit more people and the follow up time period is 5 months if I remember correctly from my interview.
Their drug may not adress severe hearing loss. It is thought to help mild to moderate hearing loss (which means 20 to 70 dB) but the drug efficacy is uncertain for more severe cases. PTA above 70 dB is not in their exclusion criteria.
And that's sad, I read somewhere that half of tinnitus sufferers have their tinnitus pitch above 8 kHz and many people, especially above 50 years old have severe hearing loss in that range which is normal, it's called presbycusis.
Some of us may not immediately benefit from this drug, we may have to wait for further improvements.
And that's sad, I read somewhere that half of tinnitus sufferers have their tinnitus pitch above 8 kHz and many people, especially above 50 years old have severe hearing loss in that range which is normal, it's called presbycusis.
Some of us may not immediately benefit from this drug, we may have to wait for further improvements.
It actually works better, the higher the frequency.
As far as 70 Hz, while that's the cut off for the study, not to say it won't have some benefit in those populations. I can't find it now but I read a study showing that, by the time, you have severe to profound loss, you have lost a significant amount of support cells too. I don't think "how many support cells are needed" is a question Frequency Therapeutics wanted to yet answer when trying to release this drug.
Pure speculation, I still think it will help but maybe not as fully but it would be especially important for severe hearing loss patients to use a non support cell depleting drug, like Fx-323 vs Audion. Another unknown: maybe with Frequency, you could redivide the cells again in 6 months and gradually work up the improvements.
A number of researchers are working on regenerating support cells, including Chen at Harvard and possibly Decibels LATS program they bought the rights to recently from Rockefeller University.
Definitely. The only thing that will different between Phase 2a and Phase 3 is more people.
If results are good for Phase 2a they should release the drug into the market.
Apart from the drug or drugs Thanos Tzounopoulos' is investigating are there other drugs designed to address tinnitus and hearing distortion in the pipeline? I'm not aware that any of the drugs for hearing loss would also be pursuing an indication for treating tinnitus. Perhaps you can bring me up to speed on that.
I doubt whether a letter to FDA will do any harm, but when I think back to the AIDS crisis for example, WHO, CDC and FDA, academics, pharma and the medical profession all came together and ultimately the drug approval process was reformed. In general, regulatory processes in the US tend to be reactionary and in the case of AIDS, the world was reacting to a deadly virus.
While tinnitus can be deadly in the sense that it is associated with euthanasia and suicides, it doesn't have the visibility and impact of AIDS.
What I would suggest is that you consider the timing of the letter. Some of us want to push for more NIDCR/NIH funded research thru processes NIDCR will follow as they formulate their 2022 Strategic Plan. We'd love for you to join the group, perhaps your letter could also be directed to other influencers and decision makers apart from NIDCR/NIH. We are scheduled to have a Skype call on the 16th. If you are interested and available, please let @Hazel and @Markku know so that you can be added to the conversation.
Many thanks, TC
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