Frequency Therapeutics — Hearing Loss Regeneration

Yes this is true but if the Phase 2a show positive results following on from the the 1 injection in the initial trial, then I think it's reasonable to assume any improvements, even if very minor (for the severe hearing loss population), in Phase 1b is something to be optimistic about for when they do their pivotal trial.

 

That's a good point.

 

Thank goodness then for OTO-6XX that is also on the horizon.

 

It would be awesome if they proceeded to Phase 3 with promising results for tinnitus and expanded trial enrollment for those who have minor/super high frequency/hidden hearing loss to be able to participate.

For those who have severe tinnitus, it could be worth the risk.

 

They are still in pre-clinical, no?

I, like the others, am betting for FX-322 to fix my hearing loss/tinnitus.

 

Yeah so am I once FX-322 shows efficacy for severe hearing loss. And if not, then OTO-6XX is targeted specifically for the severe hearing loss group. It's either one or the other unless something else pops up that is a bit more encouraging and clearer than Hough Ear Institute or a faster than PIPE-505.

I just realised you probably misunderstood what I meant by "on the horizon" - I meant as a potential existent option to come down the line for myself and people like me with severe hearing loss.

 

I’d take the risk as it stands right now and get multiple injections of FX-322 in both ears today if I could.

As someone with super high frequency tinnitus, the drug is worth its weight in gold considering it repairs the higher frequencies first.

 

There could be a possibility of them skipping the pivotal phase for FX-322 if they can get Breakthrough Therapy designation and positive results in the multiple trials they are doing this year.

 

Slightly off-topic but some people here have been bashing the FDA for years. This might make those people smile. Personally I prefer my regulatory authorities to make science-based decisions.

"FDA was blindsided Monday when HHS Secretary Alex Azar approved rules designed to reduce scrutiny of drugs and medical devices before they reach market, four senior FDA officials and a person familiar with discussions said."

FDA fights for independence in Trump administration's final days

 

One can only hope... but I'm pessimistic.

 

Same man. I’ve been trying to be positive but it can be so draining.

 

That would be amazing. I am so looking forward to this 90 day readout.

 

Don't forget about OTO-413, since addressing possible synaptopathy is a potential solution as well. There's no clear timeline for that drug, but if everything goes smoothly, it should(*) release within a year or two of FX-322.

 

This is positive and it is I think good that this is coming from the Republicans and not the Democrats. I definitely think that there are members of both sides who believe that the techniques and methods utilised by the FDA are somewhat excessive and cumbersome, hence the interest in implementing things like the Promising Pathways Act.

The thing is though that it is not necessarily a matter of treatment and medicine being rejected or approved on the basis of scientific decisions but rather the ridiculous rationale that the FDA utilises in their decision making, which does not seem plausible or is illogical. It is legislation like the Promising Pathways Act which will implement a lot of common sense into the decision making processes of the FDA.

This is an interesting theory. There is every possibility that Frequency Therapeutics has been talking about the pivotal trial because it is the normal course and also actually the likely path that FX-322 will need to take before it can gain approval to be released. This is consistent with Frequency Therapeutics' technique of not making unfounded claims about FX-322. I think that there is no way Frequency Therapeutics will say anything about possibly going straight to market post Phase 2 until they can do so, which probably won't be until such approval is granted.

 

@Princebeyel, your mom called Frequency Therapeutics regarding Compassionate Use? Can you tell more of what they said and what happened?

 

They said to wait until after my appointment on the 21st to give it three weeks and to call back. That it was a possibility they would offer it. I feel if more people would call and ask for it they may offer it.

 

Is there a serious opportunity for compassionate use? Would you have to make an appointment at their HQ in Massachusetts? Did you just call the number on their website?

 

Mmm... yeah, isn’t this huge news?

 

The process varies, but typically it requires that you and your doctor submit a request form for compassionate use. Then it’s usually a back and fourth with the doctor and Frequency Therapeutics or it’s contract manufacturer to arrange delivery, instructions for care, assessment, etc.

 

She did call the number on the website, yes, and the way it sounded, yes, there is an opportunity. I’m very hopeful.

 

I hope you are able to get this done! Your story and situation sounds horrible. I'm confident that this drug can at least make a significant increase in people's daily lives.

 

My mom actually talked to them by calling the main number. I believe in order to obtain compassionate use your doctor would need to contact them.

 

Good luck and I hope they let you get FX-322 shots.

 

Mr. Langer is talking on the 21st January... I think it's just another investor conference. What's interesting is that Frequency Therapeutics has had some big purchasing of shares, driving the price to over double of its IPO. People have confidence in this company.

My tinnitus feels like it's getting worse... but it varies. Some days it's manageable and some days it's intrusive.

NOT LONG TO GO FOLKS FOR WHAT WE HAVE ALL BEEN WAITING FOR.

 

Langer's presentation is on January 19th, 2021.

I would encourage all here to listen in, should be interesting...

The Potential for Restorative Treatments for Acquired Sensorineural Hearing Loss

 

Is the event not on the 19th January? Or is that a different one? It's nice that there will be 4 speakers including Mr. Langer so will be interesting to get some different perspectives.

Frequency Therapeutics to Host Investor Event on the Potential for Restorative Treatments for Acquired Sensorineural Hearing Loss

 

Not to get political on you, but it was the Obama/Biden administration that brought the last significant "renovation" to the FDA that brought incentives like the Breakthrough Therapy Status. As VP, Biden was a proponent of accelerating programs for treating cancer and other terminal diseases. Promising Pathways Act may see some acceleration under Biden, but probably not soon enough to affect the progress of FX-322.

However, I did notice today that Biden elevated the Science Office to a Cabinet Level position. This may lead to other legislation that promotes the FDA using more common-sense, good-science based decision-making. It may also just be virtue signaling that the Administration will be taking science seriously for a change.

Biden will elevate White House science office to Cabinet-level

 

All of the announcements, events, purchase movement of shares, etc. really shows some signs that Frequency Therapeutics knows they have something. I see all of this as excellent news and really makes me think that FX-322 might be better than what we already hope it to be.

 

I am frothing at the mouth for this stuff.

 

Does anybody know (or have some idea) how effective FX-322 may be for those with tinnitus like me; who have no real hearing loss or difficulty in hearing.

In fact I have been told by two audiologists my hearing is superb and very sensitive. My hearing test came out with both ears around the 5 dB from 250 Hz - 1 kHz, then with both ears near to 0 dB from 4 kHz to 8 kHz. My hearing test dips around the 2 kHz - 4 kHz mark in mainly the left ear (lowest to 10 dB). My buzz like tinnitus and sensitive ear is really all coming from the left ear. I have near perfect hearing tests up to 8 kHz. I think my tinnitus has come from damage to the higher frequencies.

Do we know if people like me are in the clinical trials and if FX-322 will help with those higher frequencies? Or have they just picked people with really poor hearing?