Could this new jab mean the end of hearing aids?

More good news from Europe!!

First Drug to Restore Hearing on the Horizon? New Trial Raises Hope

Love that they (Europeans) are pushing the US to the finish line...maybe the FDA will start fast tracking some of these US trials when they see Europe take the lead in this HUGE world wide opportunity.

 

Great read from Decibel Therapeutics.

Interesting theory that repairing the damaged Neuron's may actually be more beneficial than re-growing hair cells.

Decibel Therapeutics' study on inner ear cells may spur hearing-loss therapies


Also notice at the end of the article it mentions Google Ventures is backing them...That is big time folks!!

From GV website
Launched as Google Ventures in 2009, GV is the venture capital arm of Alphabet, Inc. We’ve invested in more than 300 companies that push the edge of what’s possible. In the fields of life science, healthcare, artificial intelligence, robotics, transportation, cyber security, and agriculture, our companies aim to improve lives and change industries.


As i tell you guys all the time...this is going down. Bigtime players know they are close. Its a race to the finish.

 

Pretty cool article on the future of cochlear implants. Hope these doctors can figure this new approach out.

International effort underway on hearing implant

 

This is great news. Here's a link to the Sonic Lab at the University of Minnesota, which is leading the project. They're doing some cool stuff under Dr. Lim. A while back he was working on making a garment that would reduce tinnitus when worn. I tried to volunteer, but was told they avoid people with Meniere's because the randomness of disease symptoms makes it too difficult to draw conclusions on cause and effect.

 

That would be awesome to have something smaller and with a direct connect to the brain.

 

Answer is more no than yes. I am in touch with the clinical directors and the medical directors of several of the trials underway. News is basically that just because it worked in mice (yes is a mammal) its not doing well in humans. Norvatis has a lot of $ on the line. But the last insider i talked to said it remains a next generation thing. The good news is medical science moves forward the bad news is that its slow and probably not a tool that will be useful for our generation. Truth hurts sometimes.

 

I understood from my laby surgeon that the issues are not so much around hair cell regrowth but around the neural connections. Sure, it's too late for me; but as my father had meniere's, I hope my daughter will have better treatments available if she gets the short straw.

 

You both are correct.

I spoke with the top guy at Hopkins in October. I was in his office. He is one of the lead doctors on the Novartis trial. He did not see overly positive on the Novartis trial. That is why I haven’t mentioned it in a while. They were/are focused on gene therapy.

Most of the other trials are focused on stem cell regeneration. These are all still very much in play. There are several here in the US and a few in Europe. I have been in touch with several of the CEO's of these companies. I have put links to one in particular who was looking for funding here in the US.

As to your point Clare about neural connections...that is correct. There are several theories floating that we may not need 15,000 hairs to hear but better connections for the ones we have. So regrowing hair cells may not be the only answer.

I suppose next generation is based on how old you are. I am 39. I think there is a realistic shot that this goes down by the time I turn 50. With so many companies getting so close...and so much money no the line...there is no reason to bet against it.

For those who want to donate... check out the link on the Hough Institute. They are working on a Phase 2 but need help with funding. They just got 2.2 million from the Department of Defense.

Hope everyone has a great weekend.

 

Improved TMC1 Gene Therapy Restores Hearing and Balance in Mice

 

It's interesting to see a gene therapy that addresses balance as well as hearing. Like me, my father had Meniere's, but genetic factors are not often discussed.

 

Mac,

Are you still in touch with Frequency? I have been trying to reach them myself but clearly don't have the connections you do .

Any idea if hydrops would interfere with the effectiveness of fx-322? I know they are excluding Meniere's cases but was wondering if that is because of fluctuating hearing being a variable (hopefully) rather than round window scaring and/or hydrops being an issue.

Thanks,

Fara

 

Meniere disease and ebselen: anti-neoplastic may help manage symptoms

 

Fara,

I have never been in touch with Frequency. They are a pretty guarded group up in Mass.

I follow a few other hearing (not MM) groups where the members are more focused on research. I know one of them reached out to Dr. Karp and got a response. I did try to contact Will McClean on linkedin but I struck out.

None of these stem cell clinical trials would EVER allow a MM patient in it. It makes no sense for them. Too much fluctuation in hearing. It would throw off their results. As to what it would do for a MM patients ear your guess is as good as mine. All of our issues are so unique I don't think there will ever be a standard answer to that question.

Lets just hope they have a successful phase 2 so we all have a shot of hearing a little bit better in about 10 years.

 

If you need a yes or no the answer today is no. Prosthetics now far outpacing the results of any gene type therapy. They have learned and are learning that the gene in mice and birds dont map over to humans. So not going so well. I know and have talked to the medical directors of those initiatives. Not yet its time.

 

Completely agree Sid! Unfortunately gene therapy is not even close. I have been in touch with the leads at Johns Hopkins. I met them in person in October. Did not sound promising any time soon.

It is amazing what they are doing with Cochlear Implants now! It is so great.

However I am mostly following the stem cell research though Frequency Therapeutics. As you know they just made history by becoming the first research team in human history to regrow hair cells is humans.

Press Releases - News & Events - Frequency Therapeutics


It is clearly baby steps but the mere fact they can somehow repair the inner ear is a tremendous step for inner ear research. There are several other teams (including Hough Institute) that are knocking on the door as well.

But I would tell anyone reading this...8 to 10 years.

 

I agree in regards to gene therapy but what Frequency is doing isn't that. Look up Will McLean's YouTube presentations. He is using chemical signals to cause the progenitor cells we already have to regrow hairs. This is a similar concept to intestinal mucosa cells (which can completely regrow on their own in humans in just 7 days). As it so happens, in humans, the signaling is similar, just not secreted naturally in the human inner ear. This isn't a stem cell therapy and it's not gene therapy per se.

Same with Otonomy and synaptopathy related hearing loss. Oto-413 is a drug designed to mimic BDNF so broken ribbon synapses can repair themselves. Also not a gene or "stem cell" therapy. Same with Decibel, i believe.

As far as Novartis/gene therapy (etc), not putting my hopes in those either. My hopes are in: Frequency, Otonomy and Decibel and 5 years seems to be timeline for stage 4 trials (wider market) if all goes well.

 

"Also not a gene or "stem cell" therapy. Same with Decibel, i believe."

FNC - you are right....I was just being lazy and did not want to go into details on the process...haha. watching the McClean video is pretty wild. Dude is like 30 years old. Could win a noble prize for research if this hits as they think it will.

But 5 years is pretty aggressive. Its taken Otonomy over 11 years to get a steroid gel (otividex) to get approved. Which is still 2 years away. If they hit the second phase 3 we are looking at 13 year for a harmless steroid gel!! (which is already used off label). The process is painfully slow.

Anyway...not trying to be a downer...I am hoping for 5. But thinking 8-10. But what do I know?? ha.

Hope everyone has a great weekend!

 

Ovidex is a bit of a special case because they messed up the control arm of the US study. They should have been close to release by now.

With a successful phase 2 (results mid 2020), Frequency plans to ask the FDA for accelerated approval for "unmet need". They are using the rationale that hearing loss is related to dementia. I think they will be granted AA personally.

These drugs are also in such high demand that if something is approved in Europe first (does not take nearly as long for their regulatory agencies), people will come from all over the world for treatment. There are already emerging European competitors, who would already have drugs to market first if the FDA dragged their heals. I'm sure the FDA knows this. Certainly the CEOs of Frequency, Otonomy and Decibel know this.

Look at Lenire/neuromod for tinnitus. Will be released in Europe this month but estimates predict years for US approval.

I would be more than happy to fly anywhere in the world for hearing loss treatment. I'm sure insurance won't cover it anyway.

 

Good news!

https://www.tinnitustreatmentreport...19-at-aao-hnsf-annual-meeting-in-new-orleans/

They will be releasing the results in September. Also... there are rumors of a Phase 2 probably getting started late 2019/early 2020.

I have been in a few trials my self. Its hard to understand why... but unfortunately each one stage takes around 2 years. I am still sticking to my 8 year call (Phase 2 - FDA - Phase 3 - FDA - roll out) on this drug.

I will pass along any updates as I hear them. Have a great week.