MIT Scientists Develop New Regenerative Drug That Reverses Hearing Loss

Hair Cells Nuclei, Cellular Regeneration

These images show cellular regeneration, in pink, in a preclinical model of sensorineural hearing loss. The control is on the left and the right has been treated. Credit: Hinton AS, Yang-Hood A, Schrader AD, Loose C, Ohlemiller KK, McLean WJ.

MIT spinout Frequency Therapeutics’ drug candidate stimulates the growth of hair cells in the inner ear.

Frequency Therapeutics, a biotechnology company, is working to repair hearing loss using a novel kind of regenerative treatment rather than hearing aids or implants. The company programs progenitor cells, a descendent of stem cells in the inner ear, to make the tiny hair cells that enable humans to hear, using small molecules.

When exposed to loud sounds or medicines, such as certain chemotherapies and antibiotics, hair cells die. The medication candidate developed by Frequency is intended to be injected into the ear to rebuild these cells inside the cochlea. The organization has already enhanced people’s hearing in clinical trials, as judged by speech perception tests – the capacity to interpret and distinguish words.

“Speech perception is the No. 1 goal for improving hearing and the No. 1 need we hear from patients,” Frequency co-founder and Chief Scientific Officer Chris Loose PhD ’07 states.

After a single injection, several subjects showed statistically significant improvements in speech perception, with some responses lasting almost two years in Frequency’s first clinical research.

To date, the company has dosed over 200 people and found clinically significant improvements in speech perception in three different clinical investigations. Another study found no difference in hearing between the treatment group and the placebo group, however, the manufacturer attributes this to problems in the trial’s design.

Now Frequency is recruiting for a 124-person trial from which preliminary results should be available early next year.

FREQ 162, Progenitor Cells

These two images show that one of Frequency’s lead compounds, FREQ-162, drives progenitor cells to turn into oligodendrocytes. The control is on the left and the right has been treated. Credit: Frequency Therapeutics

The company’s founders, including Loose, MIT Institute Professor Robert Langer, CEO David Lucchino MBA ’06, Senior Vice President Will McLean PhD ’14, and Harvard-MIT Health Sciences and Technology affiliate faculty member Jeff Karp, are already gratified to have been able to help people improve their hearing through the trials. They also believe they’re making important contributions toward solving a problem that impacts more than 40 million people in the U.S. and hundreds of millions more around the world.

“Hearing is such an important sense; it connects people to their community and cultivates a sense of identity,” says Karp, who is also a professor of anesthesia at Brigham and Women’s Hospital. “I think the potential to restore hearing will have enormous impact on society.”

From the lab to patients

In 2005, Lucchino was an MBA student in the MIT Sloan School of Management and Loose was a PhD candidate in chemical engineering at MIT. Langer introduced the two aspiring entrepreneurs, and they started working on what would become Semprus BioSciences, a medical device company that won the MIT $100K Entrepreneurship Competition and later sold at a deal valued at up to $80 million.

Frequency Therapeutics Founders

Frequency Therapeutics co-founders Will McLean, PhD recipient at the Harvard-MIT Division of Health Sciences and Technology (HST), David Lucchino MBA ’06, Jeff Karp, PhD, HST affiliate faculty and Professor at Brigham and Women’s Hospital, and Chris Loose, PhD ’07. Frequency went public on the Nasdaq on October 3, 2019. Credit: Courtesy of Frequency Therapeutics

“MIT has such a wonderful environment of people interested in new ventures that come from different backgrounds, so we’re able to assemble teams of people with diverse skills quickly,” Loose says.

Eight years after playing matchmaker for Lucchino and Loose, Langer began working with Karp to study the lining of the human gut, which regenerates itself almost every day.

With MIT postdoc Xiaolei Yin, who is now a scientific advisor to Frequency, the researchers discovered that the same molecules that control the gut’s stem cells are also used by a close descendant of stem cells called progenitor cells. Like stem cells, progenitor cells can turn into more specialized cells in the body.

“Every time we make an advance, we take a step back and ask how this could be even bigger,” Karp says. “It’s easy to be incremental, but how do we take what we learned and make a massive difference?”

Progenitor cells reside in the inner ear and generate hair cells when humans are in utero, but they become dormant before birth and never again turn into more specialized cells such as the hair cells of the cochlea. Humans are born with about 15,000 hair cells in each cochlea. Such cells die over time and never regenerate.

In 2012, the research team was able to use small molecules to turn progenitor cells into thousands of hair cells in the lab. Karp says no one had ever produced such a large number of hair cells before. He still remembers looking at the results while visiting his family, including his father, who wears a hearing aid.

“I looked at them and said, ‘I think we have a breakthrough,’” Karp says. “That’s the first and only time I’ve used that phrase.”

The advance was enough for Langer to play matchmaker again and bring Loose and Lucchino into the fold to start Frequency Therapeutics.

The founders believe their approach — injecting small molecules into the inner ear to turn progenitor cells into more specialized cells — offers advantages over gene therapies, which may rely on extracting a patient’s cells, programming them in a lab, and then delivering them to the right area.

“Tissues throughout your body contain progenitor cells, so we see a huge range of applications,” Loose says. “We believe this is the future of regenerative medicine.”

Advancing regenerative medicine

Frequency’s founders have been thrilled to watch their lab work mature into an impactful drug candidate in clinical trials.

“Some of these people [in the trials] couldn’t hear for 30 years, and for the first time they said they could go into a crowded restaurant and hear what their children were saying,” Langer says. “It’s so meaningful to them. Obviously more needs to be done, but just the fact that you can help a small group of people is really impressive to me.”

Karp believes Frequency’s work will advance researchers’ ability to manipulate progenitor cells and lead to new treatments down the line.

“I wouldn’t be surprised if in 10 or 15 years, because of the resources being put into this space and the incredible science being done, we can get to the point where [reversing hearing loss] would be similar to Lasik surgery, where you’re in and out in an hour or two and you can completely restore your vision,” Karp says. “I think we’ll see the same thing for hearing loss.”

The company is also developing a drug for multiple sclerosis (MS), a disease in which the immune system attacks the myelin in the brain and central nervous system. Progenitor cells already turn into the myelin-producing cells in the brain, but not fast enough to keep up with losses sustained by MS patients. Most MS therapies focus on suppressing the immune system rather than generating myelin.

Early versions of that drug candidate have shown dramatic increases in myelin in mouse studies. The company expects to file an investigational new drug application for MS with the FDA next year.

“When we were conceiving of this project, we meant for it to be a platform that could be broadly applicable to multiple tissues. Now we’re moving into the remyelination work, and to me it’s the tip of the iceberg in terms of what can be done by taking small molecules and controlling local biology,” Karp says.

For now, Karp is already thrilled with Frequency’s progress, which hit home the last time he was in Frequency’s office and met a speaker who shared her experience with hearing loss.

“You always hope your work will have an impact, but it can take a long time for that to happen,” Karp says. “It’s been an incredible experience working with the team to bring this forward. There are already people in the trials whose hearing has been dramatically improved and their lives have been changed. That impacts interactions with family and friends. It’s wonderful to be a part of.”

If you are interested in participating in the trial more information can be found here.

85 Comments on "MIT Scientists Develop New Regenerative Drug That Reverses Hearing Loss"

  1. What about tennitus

    • Raymond Alvarado | April 9, 2022 at 9:23 pm | Reply

      I want to become a patient and receive help with my hearing.

    • David B. Smith | April 11, 2022 at 11:38 am | Reply

      My son forwarded the article to me and I have tennitus since an industrial incident in 1983. This could be an advancement to the long sought cure for tinnitus as well. My hearing has diminished as time has passed to the point that the loud ringing is overtaking the ability to hear as I once did. I would be interested in the potential for being added to a trial if thought feasible. Please respond either way.

    • I had this exact question! I would love some relief from my tennitus.

  2. Neal Jacobsen | April 9, 2022 at 4:54 pm | Reply

    How do I get to be a patient for the hair regrowth in my ears. Without hearing aids I am deaf,

    • Better than Hearing Aids | April 10, 2022 at 4:32 am | Reply

      Must Attempt on Low Frequency Loss, Since Hearing Aids do not exist

      • Better than Hearing Aids | April 10, 2022 at 4:43 am | Reply

        1 of 5 Senses: Sight, Sound, Smell, Taste, and Touch; This Shows how SciTech is Far Superior To Activities of Politicians & of Other Group (Unfortunately, No one Criticizes this 2nd One and I do not want to name it; This Group Relies on Magic… Unbelievable, But Vastly Believed)

        • Sherry L hora | April 10, 2022 at 5:06 pm | Reply

          Like to join study. I too have significant hearing loss over last few years. I am 67 yrs old and am female. Thank you very much! My cell number is 724-797-1309.

          • Never ever ever tell you phone nu.ber in a public post, now everyone has it . Advise you change your number

      • My daughter is suffering from hearing loss how can she get help

      • NorthwoodsMJS | April 12, 2022 at 10:39 am | Reply

        “Since Hearing Aids do not exist” ?!?!?!?! A very misleading information right there! Hearing Aids DOES EXIST. Please do your homework before you make your comments.

        • Tinnutus will probably be partly to completely reversible for some people, assuming this treatment ever gets approved. According to popular scientific research papers, tinnitus is usually caused by the *brain* creating a false noise after it detects an unusually weak signal from the (damaged/decayed) hearing cells. So, if those hearing cells are fixed, the brain would no longer sense an unusually weak signal and would stop creating the fake noise. Of course, this is just an estimation of how it would work out for most people. Not all tinnitus is the same and the way it happens is still poorly understood.

    • Colin Collins | April 10, 2022 at 10:18 pm | Reply

      More information about the trial can be found here: https://clinicaltrials.gov/ct2/show/NCT05086276

  3. How can I volunteer to be a patient

  4. Laura Mathis | April 9, 2022 at 7:29 pm | Reply

    Needing info on restoring hearing. Tinnitus also

  5. Jody Lynett Mayes Sanders | April 9, 2022 at 8:38 pm | Reply

    What is available for me using this technology? I’m highly upset that this has been kept a secret from me for so long. I’ve been physically and emotionally shut down and denied benefits since 12-18-1972. I never gave The United States Navy to use me as a test rat. Personally I’m fed up and tired of everything and everyone progressing and innovating all around me while I am ignored and denied for everything under the moon. This is a civil rights violation.

  6. I’d like to be part of the trial

  7. Simphiwe Mthembu | April 9, 2022 at 10:01 pm | Reply

    Where can I find this Regenerative drug, especially in South Africa?

  8. I’m 50 yrs old I haven’t been able to hear since I was 12 ear infection my mom put oil on the cotton ball an I went back out to play an it slid down an we thought it fell out when I went back out to play but I wasn’t hearing ppl my teacher as she walked around so my mom called me an I jumped an she says you didn’t hear me calling you then that’s when I told her I was having problems Hearring an took me to the doctor they found the cotton had devolved and blocked my hearing my life is terrible an I can’t interact with ppl well my hearing calls problems for me an my other ear is mild so I have a cross an I’ve had 3 hearing aids an they don’t help so now I’m blind in one of my eyes an the other is partial someone help me make me a believer that I can hear again what I’m going threw makes you want to give up I’m not no good to no one not even myself how do get some help if I can’t see let me hear they say it’s get strong when you loose one but I have no hearing an no sight anI can’t get a good hearing aid because ot my insurance HELP PLEASE ..Thank you

  9. I am 42 years old and suffering from hearing loss since after the birth of my 3rd daughter who was born when I was just 32 years old.I am fed up of tinnitus and severe hearing loss .Can you help me please.

  10. Rose Westcoast | April 10, 2022 at 12:02 am | Reply

    I would love to be one of the people on your trials my hearing is absolutely not great I’ve had surgeries on both my ears and am having to wear a generic hearing aid I don’t really interact with others they must think I’m anti social my home is in alaska specifically palmer God bless you all for such your miraculous work

  11. Margaret Akinbo | April 10, 2022 at 4:39 am | Reply

    Please help me ,my daughter lost her hearing for the past 13 years.how do I go about the treatment to restore her hearing.

  12. Better than Hearing Aids | April 10, 2022 at 4:45 am | Reply

    1 of 5 Senses: Sight, Sound, Smell, Taste, and Touch; This Shows how SciTech is Far Superior To Activities of Politicians & of Other Group (Unfortunately, No one Criticizes this 2nd One and I do not want to name it; This Group Relies on Magic… Unbelievable, But Vastly Believed)

  13. Earlier the Better | April 10, 2022 at 4:51 am | Reply

    It seems So Many are aspiring to treck this alternative method. SciTech is Far Superior To Activities of Politicians & of Other Group (Unfortunately, No one Criticizes this 2nd One that Relies on Magic… Unbelievable, But Vastly Believed)

  14. I have severe hearing loss, how can I get this New treatment??

  15. I have hearing loss as well as tinnitus and would be interested in getting help with this

  16. I would like to try it because I been deaf since I was 6 years old. I was sick and lost my hearing.
    I been using the hearing aid for a long time.
    It’s so frustrating that you can’t hear that good with hearing aid .

  17. I began loosing my ‘low range’ hearing in 2008- why I don’t know. It began on the right. I have very low word recognition there now. My hearing aid does nothing there anymore! I still have hearing on my left with my hearing aid, but take it off and it is almost gone. I am so very healthy for my age in ALL other ways!
    My sons have low range voices and it makes it hard to hear and comprehend them even with my hearing aide.
    I would really like to be able to be part of a TRIAL for this new technology as I have read so much about it in the recent past! TY, PF, RN

  18. Patricia Foster, RN | April 10, 2022 at 8:28 am | Reply

    I began loosing my ‘low range’ hearing in 2008- why I don’t know. It began on the right. I have very low word recognition there now. My hearing aid does nothing there anymore! I still have hearing on my left with my hearing aid, but take it off and it is almost gone. I am so very healthy for my age in ALL other ways!
    My sons have low range voices and it makes it hard to hear and comprehend them even with my hearing aide.
    I would really like to be able to be part of a TRIAL for this new technology as I have read so much about it in the recent past! TY

  19. I would love to be a patient. I am 83 and willing to be on a trial, or testing basis

  20. I’m very interested in this

  21. Please forward information about this new treatment

  22. Sandra S. Power | April 10, 2022 at 9:28 am | Reply

    I should be very interested in being part ot he testing for this new treatment for hearing los,. having lost considerable hearing over the last 10 to 15 years.

  23. Lizzie Gutierrez | April 10, 2022 at 9:41 am | Reply

    I trully believes in Sciences and I would love to be part of that treatment for hearing lost and tinnitus. I am about committed suicide if I cannot get rid of this tedious problem. Please help me to hear clear for my last years of life. Thanks.

  24. I
    suffer from bilateral hypofunction and would be interested in being involved in this research.

  25. I’m 67 and have had hearing loss for many years. I would love to participate in this study

  26. Kenneth Valentin | April 10, 2022 at 2:00 pm | Reply

    I would gladly volunteer for this research. I am 72 years . Please advise. I have a significant hearing loss and speech discrimination problem.

  27. Charlie Gabel | April 10, 2022 at 3:34 pm | Reply

    I would be interested in being a trial patient. I am 66 years old and suffer from almost continual tinnitus and ringing in the ears. I also have developed hearing loss over the past several years. How do I go about getting in on clinical trials for the inner ear hair regeneration?

  28. Christopher Brown | April 10, 2022 at 3:55 pm | Reply

    I would be interested to see how this therapy affects tinnitus. After recovering from Covid, my tinnitus has reached new levels of screeching.

  29. As someone affected with sudden hearing loss I had really high hopes for this drug. I even invested in the company. Their previous phase 2 trials showed the drug to be no better than placebo and the stock tanked. Hopefully they come up with something new to try, but I feel like a cure is many years off.

    • It’s very important to hear voices like yours. No pun intended. I was skeptical of the hope level this would article would initiate, and the comments prove those worries were justified. When they said a trial failed to show results, that is a huge red flag. Pharma companies can design trials to show a drug “works” in some infinitessimal amount for just a few people, yet that drug will then be approved. It seems this drug does help some people, but it also seems the article’s author has been “captured” by corporate PR and is not managing expectations properly. Drugs that do little for most of the patients are not something that a Sci Tech Daily article should be crowing about. Still, I remain hopeful a drug will help some people, and maybe even me if I’m lucky.

  30. I’m a great candidate for this. I have tinnitus of multiple frequencies. Some are even randomly pulsed. How to be in a trial?

  31. I’m a 69 y.o. Army veteran. I where cic hearing aids now, have tinnitus and would like to be involved in the hearing protocol trials being conducted.
    Thank you

  32. Jan Andersson | April 11, 2022 at 1:58 am | Reply

    I have hearing loss because of tinnitus to the point where i have to ask those i speak to, to please repeat what they said. Especially in noisy environments. Is there ANY chance of getting this kind of help in Sweden? I’m more than willing to be a test subject.

  33. Rogaine, topically applied to the inner ear, would work as well?

  34. Allan bullock | April 11, 2022 at 2:45 pm | Reply

    I am interested in joining one of your trials for hearing loss.

  35. Steve Willis | April 11, 2022 at 7:45 pm | Reply

    I have serious hearing loss,tinnitus,& Meniere’s Desease. Can I be helped? Vertigo can be debilitating.

  36. Alice T Rubio | April 12, 2022 at 7:33 am | Reply

    I have mixed (both conductive and sensorineural) hearing loss. The sensors neural portion is mild to moderately severe range.
    I would like to be considered for a trial when available.

  37. NorthwoodsMJS | April 12, 2022 at 10:43 am | Reply

    I see there are need clarification about this article. The first thing that come to my mind is who’s candidates or patients? Are they deaf? Are they Hard of Hearing? Please expand on “Hearing Loss”. Also, what had happen to languages access?

  38. Michael Sarkisian | April 12, 2022 at 1:47 pm | Reply

    I’m a Veteran suffering from tinnitus, would this help me?

  39. Regarding people asking to join trials, it seem authors of articles like this should add a clause that says the web page is not a recruiting offer for the company in the report! Sci Tech Daily publishes articles. They don’t have staff members sitting around offering expensive-but-free patient trial consultations.

  40. George Santucci | April 13, 2022 at 8:14 am | Reply

    Great article and Great News,
    I am 78 and began loosing my hearing @ 22 while serving in the USAF working on B-52s KC135s and the
    rest of my working life on big civilian Jet Planes. Been wearing Aids for well over 25 years and have become
    a loner or unable to understand speech well. I hope to live long enough to see this evolve faster.
    I would love to be a part and help out your development.

  41. Since tinnitus is within the brain – not in the ears – this treatment looks to be ineffective.
    Besides, who wants hair in their brain?

  42. James Kent Rubottom | April 13, 2022 at 11:13 am | Reply

    I am 70 years old and have had tinnitus and hearing disability since grade school. I have extreme trouble in crowded situations and have become a recluse and loner because of my hearing disability. And I have dreamed for years of a trial that would regenerate nerve cells and restore my hearing to something close to normal. I would be honored and thrilled to become a part of this trial.

  43. James Kent Rubottom | April 13, 2022 at 11:17 am | Reply

    I am 70 years old and have had tinnitus and hearing disability since grade school. I have extreme trouble in crowded situations and have become a recluse and loner because of my hearing disability. I have dreamed for years of a trial that would regenerate nerve cells and restore my hearing to something close to normal. I would be honored and thrilled to become a part of this trial. Hearing aids aren’t particularly effective, especially in noisy environments.

  44. Yet another “miracle drug” that will probably never see the light of day. The hearing aid industry simply won’t allow it. Like everything these days, cures are not desired, only treatments that don’t last. Oh wait. I’m wrong. It says it “lasts” up to 2 whole years. That’ll be another $25,000 Mr. Nobody or you’ll hearing will go kaput once more. What a surprise.

  45. Fake news – the company is trying to boost the stock price (FREQ) after having badly failed and crashed. Do not be fooled just because “MIT” is mentioned a thousand times in the article. The “drug” does not work and never will. Management even sold a ton of stock BEFORE the last disaster trial readout…hmm…where is the SEC when you need them?

  46. Im curious if your trials are including individuals with Tinnitus? If so I would like the chance to be included if possible.

  47. I have severe hearing loss , comprehension is the biggest problem. I hear noise , buys mostly cannot understand where or what sounds they are Words get muffled mostly and I rely on reading lips to help with comprehension I have had several surgery’s (cholesteatoma) and several very severe infections ( mastoid ). I would love to participate in your trials I look forward to possibly hearing from you
    Sincerely
    Bill Doheny

  48. Ronald Johnson | April 16, 2022 at 8:56 am | Reply

    I was able to pick out the MBA at the first glance.

  49. I am 33 years old. One ear cannot hear since childhood. The other ear has been deaf for the last 6 years and now I have got cochlear implant but no significant benefit

  50. No-Name Needed | April 19, 2022 at 7:08 am | Reply

    This is the next level of Nazism’s Eugenics…Why can’t they focus on other things instead? Always have a burning goal to destroy the deaf population out of existence.

  51. Neil Smallman | May 5, 2022 at 9:48 pm | Reply

    I am 52 and have early stage hearing loss and moderately bad tinnitus. Would love to be included in the next clinical trials

Leave a Reply to Dr Stanley A Boucree Sr Cancel reply

Email address is optional. If provided, your email will not be published or shared.