Frequency Therapeutics — Hearing Loss Regeneration

Discussion in 'Research News' started by RB2014, Dec 8, 2016.

    1. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      Estimated Study Completion Date: September 30, 2020

      Pffffffff...
       
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    2. Street Novelist
      Depressed

      Street Novelist Member

      Location:
      Bay Area
      Tinnitus Since:
      February 2018
      Cause of Tinnitus:
      Listening to loud music through headphones
      I thought they were going to have this in multiple states, not just one. How is this any better than the one in Texas? Plus, you could still be one of the people who receives nothing but the placebo.
       
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    3. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Nasty Swamp
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      No, make money, that is the goal of any corporation.
      Read the goal:
      51MdCgAGeDL._SX331_BO1,204,203,200_.jpg

      Making profits is the absolute goal of all corporations. Helping people is secondary.
       
    4. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      Regain will finish Phase 2 in December this year and have results next year end of April.

      Hopefully Regain will go to Phase 3 next.
       
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    5. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      I have no clue why Frequency Therapeutics had to wait until now to start Phase 2a. They could have recruited people earlier.
       
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    6. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Count on a second phase 2 trial first with more severe types of hearing loss. Right now the cut off for them is moderate hearing loss. Won’t surprise me if they go to ‘severe’ in phase IIb. They even said on the Action on Hearing Loss UK website that they are looking at that.

      I can’t stress this enough: these are hearing loss drugs, not tinnitus or balance drugs. It’s not gonna be like “Aha, this cures tinnitus/balance issues per our Phase 0! Screw hearing loss, let’s get this on the market now!!”
       
    7. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      Yea maybe. Hopefully they can go straight to phase 3.
       
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    8. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      If they are going to expand the patient population, they probably want to go through a Phase IIb trial first. I doubt they will go to the EMA for approval for severe hearing loss patients with just one Phase III trial. Another possibility is to do two Phase III trials, which takes even longer.
       
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    9. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Nasty Swamp
      Tinnitus Since:
      May 1st 2018
      Cause of Tinnitus:
      Aspirin Toxicity/Possibly Noise
      Because we are simply not that lucky. :(
       
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    10. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Recruiting a center, recruiting doctors/researchers not involved in the company, working on the trial design, getting it approved by the FDA, screening patients, getting money to finance it... Frequency has no incentive to act slower than necessary.
       
    11. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      My beef is not so much with trial design, but a lack of expanded access during clinical development and unnecessary time between trials. Take the Hough pill for example. These guys are sitting on a 5-year old safety study that a pill they have in a drawer somewhere in Oklahoma is “extremely safe”, uses two compounds one of which you can get in a drug store, gets you a little bit of hearing back, and quiets your tinnitus. Why can’t I buy it while they are investigating it in further trials?
       
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    12. Mr Mister

      Mr Mister Member

      Tinnitus Since:
      1996
      Cause of Tinnitus:
      Hearing loss, loud music
      That is a good question. There is still a share price stabilisation mechanism (overallotment) ongoing following the IPO so current price probably does not yet fully reflect freely traded price. As the share price is at the lower end or below IPO price range it is likely that underwriters have bought back some shares to stabilize the price.

      “Frequency Therapeutics (FREQ) will offer 6.7M common shares at $14 – 16 in its IPO. Underwriters over-allotment will be an additional ~1.0M shares.”

      It is not an easy share to value as they don’t have the typical P&L items for valuation but instead share price will be newsflow driven for quite a long time. It is important that now following the IPO and previous financing rounds they have very solid funding base that should allow for advancing the development as planned and hopefully speed it up further.
       
    13. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

      Location:
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      Aspirin Toxicity/Possibly Noise
      Sir, I've been going absolutely mad over the lack of access to these potential treatments and the time it takes to check all the boxes. It's all about money and markets. Don't listen to idiots that keep saying this is all about safety and protecting us from snake oil. I get that, the time it takes to perform these trials is artificially inflated.
       
    14. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      Dream on... for example CFG166 is in phase 2c after more than five years... courtesy FDA.
       
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    15. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Especially with Hough, this seems like an FDA overreach. They should be able to use this drug on patients at Hough since it is deemed safe and developed there. If they needed the FDA to sell it to a wider market, I get that but the drug was developed at Hough and Hough sees otologic patients clinically.
       
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    16. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      Seriously. Wow that’s a long time. Well they can’t wait too long or a competitor will release it first and they will lose big bucks.
       
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    17. Coleoptere
      Alone

      Coleoptere Member

      Location:
      The Hague
      Tinnitus Since:
      2002
      Cause of Tinnitus:
      Bell's Palsy, hearing loss
      Yep. Audion is now a half year ahead.
       
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    18. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      That’s if they go straight to Phase 3 and I hope Phase 3 is similar to Phase 2 period then hopefully they can release to the market
       
    19. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

      Location:
      Nasty Swamp
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      Cause of Tinnitus:
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      I've been saying this ad nauseam, but the FDA serves in part as an artificial barrier of entry to protect the markets from disruption. It's not a conspiracy theory, it is obvious. They aren't there just to make sure the drugs are safe (because they aren't) and effective (which many of them actually are, because they have to be to make money).

      If the Hough Ear pill worked well and was safe and was released tomorrow, what kind of hit would the hearing aid industry take? How many of their lobbyists would be flying straight to DC to spread disinformation about the pill? It would happen just like that.
       
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    20. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      CA
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      04/2019
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      U.S. Army/Field Artillery Veteran
      They might increase recruitment centers along the way, it's happened before.
       
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    21. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      .
      The hearing aid industry would definitely take a big hit if this drug were to come out and cure our suffering.

      I wonder what they would profit off instead. Custom made earplugs.
       
    22. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      I think CGF166 is still in phase 1/2, but they are doing it in tranches so to speak, hence the ‘c’. I think the reason that drug is in particular long development is because of previous gene therapy trials were people got hurt/died (I have to look it up). I think that’s also the reason the FDA won’t lower the entry to moderate or mild hearing loss. Too much risk. It doesn’t have anything to do with the drug being more tailored to profound hearing loss cases. In fact, it will probably be less effective for that category since they generally have the fewest supporting cells.
       
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    23. Jurger

      Jurger Member

      Tinnitus Since:
      2004
      Cause of Tinnitus:
      Hearing loss
      Well, hearing regeneration drugs have one advantage in terms of durations of trials: either they regenerate hair cells or nerve endings or they don’t. You’ll probably know how well a patient will do on the drug six months after the last treatment, maybe even sooner. Compare that to for example a drug that halts Parkinson’s or MS or something, where you have to follow patients a few years to make sure the drug stops the progress of the disease in the long term as well. And patients generally have to keep taking those kinds of drugs, so that would be another reason to follow them a few years.
       
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    24. Auron
      Dead

      Auron Member

      Location:
      Planet Earth
      Tinnitus Since:
      Spring
      Cause of Tinnitus:
      Acoustic Shock
      Ouch. And that is just a 2a... Maybe it's time to go down the rabbit hole and try to find something natural that can help restore hair cells and synapses... At this rate, even if successful, we are looking, at best, 5-7 years until this gets released. And if these treatments in trials fail, then forget about it, we would be looking at a decade+ worth of waiting.

      That seems like an impossible waiting game.
       
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    25. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
      SE Asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      The hearing aid industry is here to stay... we’re talking at lest 20 more years if not forever. Hopefully they will get better too. In my humble opinion.
       
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    26. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      I just checked ClinicalTrials.gov and it says completion date 30th September 2020.

      So when will they publish the results and tell us the good news?
       
      • Good Question Good Question x 1
    27. Auron
      Dead

      Auron Member

      Location:
      Planet Earth
      Tinnitus Since:
      Spring
      Cause of Tinnitus:
      Acoustic Shock
      Probably sometime in 2021...
       
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    28. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      I pray to God that Regain goes to Phase 3 after they are done with Phase 2.

      Anyone know how Regain/Audion fast track status works? If they go to Phase 3 can they release the drug after that or will there be a Phase 4?
       
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    29. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      You should maybe read up a little on clinical trials in general. There is no such thing as phase 4.

      Sometimes there are two or more separate phase 3 trials though like was the case with AM-101... but they did that because they changed the outcome measures trying to get the trial to be successful, and yet ended up failing.
       
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    30. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      That’s good to hear. I do think Regain works so I don’t think they would have to do any extra. Just Phase 2 and 3, then release to the market.
       
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