Frequency Therapeutics — Hearing Loss Regeneration

This might change with fast-tracking? Or is that only for when all the phases are completed? Also, as far as I can remember phase 3 is usually involving hundreds of participants, so maybe there's a pretty big chance to get on one of those?

I was almost admitted to the phase 3 Auris Medical trial in Germany, since I live in Austria. But I didn't get in because I'm not fluent in German. But looking at the results I don't really care in hindsight

 

https://xconomy.com/boston/2018/08/...secures-50m-for-hearing-loss-gene-therapy-rd/

So to be clear, Akouos, Frequency Therapeutics, Novartis and we know nothing of any success from these trials? I just want to know is that where it stands, not trying to be rude. Not one person who has taken these drugs has told anyone they're 100% good to go? And no results of any trial posted by the companies.

 

I would not be surprised if phase 3 lasted more than 1 year or nearly 2. Keep in mind that these are more extensive trials.

I am learning to be "happy" with the idea that this will be available from here to 5 years. Not sooner.

 

A few weeks ago the CEO of the company gave an interview with Bloomberg stating they hoped to report results from 1.5 in January 2019.

As I am typing this, Frequency Therapeutics is giving a presentation at the JPM conference, which is the premier healthcare/biomedical investor event in the world.

People are all keeping their fingers crossed that they will report spectacular results from 1.5, and hopefully the presentation will be made available on the web by tonight or tomorrow.

 

it must be great to be young, successful, presenting at huge investor conferences, doing cutting edge science knowing you'll have great job security for the rest of your life while the people your drug is going to help lose their minds, kill themselves, have their relatives treat them like dirt for expressing their suffering, suck at their job because they can't concentrate, can't sleep, can't go out and really do anything because noises hurt them, and their lives just fall apart in general, while you drag your ass in the FDA grand waltz.

 

https://buffalohearingcenter.com/our-news/ku-gene-therapy-holds-new-hope-for-restoring-hearing

Amanda James first noticed a difference early this year when she picked up a pill bottle at the Norfolk, Va., pharmacy where she worked and shook it next to her right ear.

For the first time, she could hear the pills rattling inside.

James, 29, has been hearing impaired ever since she slipped into a swimming pool as a toddler and nearly drowned. The accident starved her of oxygen and obliterated the fragile microscopic hair cells of her inner ear that turn the motion of sound waves into nerve signals sent to the brain. She lost almost all the hearing in her right ear and retained just enough in her left ear to get by with a hearing aid.

But after receiving an injection directly into her right inner ear as part of a study at the University of Kansas Hospital, James seems to be slowly regaining some of the hearing she lost.​

Amanda was part of the Novartis trial. I found one person. Not sure if I can find any more. I'm sure everyone in these trials signed non-disclosure paperwork. We will hear about it when they tell us we can hear about it. Others in the trial had mixed results. One had no improvement and went on to get a CI.

 

Ok, thanks.

 

Unlikely. In the press release of yesterday it is described as 'ongoing'. Does anyone want to read any significance into that? Estimated completion was December 2018.

 

A financing round like this is always a validation for the technology/drug development in a way that the venture cap investors get full disclosure of all the available data to date. It is great that Frequency Therapeutics is now fully funded but the selection of investors leaves a bit puzzled. This financing round was lead by Taiwania Capital which is an IT focused venture cap based in Taiwan and they closed their first healthcare fund late 2018. So not exactly a long track record in the sector.

I checked their site and it seems the management and board are mainly IT guys and some with backgrounds in Chinese corporate management. It is not exactly your tier 1 life science fund and it leaves one wondering why the large US based healthcare funds did not participate and invest in this financing round? After all the market is huge with 500 million people suffering of hearing loss.

Maybe the conditions proposed by the tier 1 funds are too demanding and restricting, maybe their valuation is too greedy or maybe Frequency Therapeutics just wanted to have an Asian investor for some reason, or wanted to get some "dum money" in quickly to advance the studies.

Anyways, it is a major positive that Frequency Therapeutics is fully funded going forward and certainly indicates positive efficacy results to date.

 

True, I kind of overlooked this while reading it. It says trial is "ongoing" and results are "expected in the first half of 2019". That's a bit frustrating. Not sure whether this can be taken as a positive, negative or neutral indicator though.

 

I choose to regard the fact that this company presents some preliminary facts & figures of an ongoing trial and manages to secure an investment for $43m the very next day as positive sign. Not negative.

Forward is good! Let them go on with their business... they’re doing the FDA dance, but they’re making good time. You don’t want to see them rush it and trip.

 

The drug already exists, it is safe, and it activates hair cell regeneration. The FDA is just slowing everything down. What? Are they protecting us from? A drug that's already proven safe?

 

If they're doing another trial we all gotta get in there bois.

 

Today I made a post on Facebook with the news that a Hearing Restoration Company obtained millions for financing.

Only 1 like (my mother).

I think we are the only ones crying out for this to happen. And nobody will speed up the process.

 

I hear you. I never talk about my tinnitus to my friends unless I really have to, because I know it must be boring as shit. Everyone has their own shit to deal with... unfortunately.

 

While this is true, I find personally that the issues people have around me are ones that can be fixed or resolved, while we have no true solution accessible to us as of now.

Not being taken seriously while at the same time having no real recourse to improve, means we carry the heavier burden.

 

Yes. at least you got 1 like. whenever I make a tinnitus related Facebook update I get zero feedback.......I gave up a while ago.

 

It's sad, but no one really cares. You would think with all the issues tinnitus and hearing loss causes there would be more publicity and funding. We are the extreme minority. I see the silliest things getting so much publicity and hearing loss gets almost none. Try to do a fundraiser and you will be very disappointed. I have tried numerous times to bring these issues out and they have all failed. I'm glad frequency is continuing their efforts though. I'm guessing that everyone that has funded them has more information than we have so this is all good news.

We have come a long way, but we still don't fully understand how our hearing works. Right now they only have bits and pieces of a pretty large puzzle. I know its a long strung out process, but they are trying to protect us from any number of unknown long term effects that could happen. What happens in 5 years..... 10 years..... Does it improve hearing, but not speech understanding??? This is a big one that has yet to be answered.

Look at the Novartis trial. The results were really mixed. I still don't think they understand why it helped some people but not others.

 

Definitely agree with that. I'd change my tinnitus for a whole basket of "regular" life problems any day.

 

Long term side effects? How much do we need? Can we repeat the treatment or is it a one shot opportunity?

I hate my tinnitus and hearing loss, but I really want to be sure that it's safe and sound and most of all as effective as possible. I wish that for everyone here.

 

Nothing, the drug leaves your body. Why not just wait until we're all old and dead to release it so we can be reallllllly sure????

They already know basically how well it works from this trial. I'm sure of that.

 

It leaves your body very rapidly, that has already been shown. I doubt the regenerated hair cells are going to sit around for years and then morph into cancer cells or grow you a new head.

 

Could be dope though... as long as it cures the tinnitus. Wouldn't want four tinnitus ears.

 

Like you, I would inject that drug into my ears tomorrow. I do not think there is an adverse effect more horrible than severe tinnitus.

However, what they tell us about "the drug leaves your body in XX hours" does not guarantee its innocuousness.

I stopped taking finasteride (for baldness) 18 months ago, and I still experience horrible fluctuations in my libido. I remember reading that the drug left the body in a few days, however the damage is apparently done.

 

I used to post research information on Facebook tinnitus groups but got little response/got comments that there will never be a cure etc.

I don't know if it’s just me but it seems like a lot of them there like to drown in their negativity instead of addressing their issues.

I gave up and left when a lot of them said they wouldn’t be willing to donate to research, or at least spread awareness.

 

We'll have cured cancer by the time it's out :^

 

So... The news was that they've received a bag of money? Or is there something more on the horizon?

 

If the new head comes with new ears I could get rid of my old one, also a result that I could live with.

 

If you get debilitating tinnitus as a result of that treatment, you will get the answer to the question above...

 

Don't we already have that? Hence our user accounts on tinnitustalk.com?