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Is this the same thing that FX-322 already tried or is there anything different here?

SIU scientist receives DOD grant to advance hearing loss treatments

There's a chance we might get some random good news of long term improvement in trial subjects and resumption of trials.

I can see the U.S. military having an interest due to combat related hearing loss.

This was huge progress towards curing hearing loss. It would be worth it for another biotech company or U.S government/military scientists to keep studying this drug and figure out what needs to be changed to get it to work.

FREQ scientists would have probably been able to figure out how to fix this if they hadn't laid them off and canceled the clinical trials. Let's hope someone else can try it.

It's possible that FX-322 was successfully restoring hair cells but the brain is not able to pick up that new input without some kind of external stimulation.

I think what was needed is a separate drug after to help with nerve connections and then something for the brain to help it process the new sounds again.

I know I'm probably beating a dead horse by now but I have a slight feeling that there might be long-term improvements in the trial subjects, maybe as far off as 3 years. It's possible that these drugs start off a very long and slow healing process and it wouldn't be reasonable to expect...

I think a more established company with already approved drugs and lots of money should keep testing these drugs indefinitely due to the fact they can restore hair cells in mice. That alone is huge progress that shouldn't be abandoned.

To me it just felt too soon to cancel the drug at 90 days after correcting the trial design. They should have compared day 1 of injection to at least a year later. It would be a shame if people are improving later on but it's too late to continue the trials. Spiral Therapeutics should try to...

I wonder what would happen if some trial subjects call back to report improvements in their hearing at 12+ months. Would they consider restarting the project or is it just dead forever?

How is it that they can regrow hair cells in mice and donated cochlea with FX-322?

How is it that people improved up to a year later during the first trial but now there is no improvement? I wonder if they're still going to keep testing the trial subjects to check for any gains at 12 months. This is basically restarting a fetal process in our ears that already happened in the...

Did they say if anyone at least had any improvement in the trial?

I think they already did it on a donated cochlea a few years back.

How do you feel about FX-345?

Has FREQ ever applied for a DoD grant for hearing loss treatments?

I think they avoid the word cure because it's only a small hearing improvement and won't go back to 100%.

Would someone with severe/profound hearing loss still be able to improve?

I thought those with severe hearing loss had the best improvement compared to mild hearing loss. Edit: I think it was only severe hearing loss that was noise induced/sudden and not age related.

Do you know why he was able to improve so much with FX-322 only reaching the high frequencies?

Could be enough to get by with just hearing aids and avoid cochlear implant surgery. Also, a small improvement would help you to wait for the better drug, FX-345, to advance in the trials.

Do you think we'll have expanded access in Phase 3?

I think they haven't released anything for FX-345 yet. I'm not sure.

Both FX-322 and FX-345?

Do you think FX-345 will get more outer hair cells than FX-322?

Hoping they bring the Phase 1 FX-345 trial to Miami, Florida. I didn't go through with the FX-322 trials because it would have been an over 200 miles drive to get there.

People maintained hearing benefit a year after the FX-322 shot. I hope it can be permanent.

I hope that would be the reason and it's nothing to do with FX-322.

Does anyone know yet why subject 5 got a lot worse from baseline after the shot?

Will they allow expanded access/compassionate use if it makes it to Phase 3 and is still safe?

Anyone know if there is a chance that the FDA might announce a surprise approval out of nowhere if there continues to be no adverse reactions? Since Frequency Therapeutics have Fast Track status, maybe they won't have to go through the full process.

Do you think it'd be possible to convince them to bring an FX-345 trial to Miami if I keep emailing them the same question? I'm willing to take the risk of being in Phase 1 trials.

Looks like maybe a minor correction where the hearing level stabilizes. It seems to hold steady a year later except for subject 5. Who knows if they went to a ton of concerts in between the exams.

Do they know yet if these drugs were effective toward sudden hearing loss/deafness in one ear?

I got an automated response with another email for Clara Health and I sent them the same question.

Anyone know of any email contact we can ask to bring a trial to our location? I live in Miami and didn't have any luck with FX-322 trials.

I'm not sure but I think it was that they extracted the mouse ear and applied the drug directly which I don't think would be possible in a live human.

When do you think they would allow compassionate use if they have good results in their trials? Just had one in my right ear for steroids, it wasn't so bad.

I wonder if Frequency Therapeutics has an email we can write and ask for that. I would sign a release form to try it.

I wish there was a way the FDA can just let us all try it now and assume the risks.

If the ingredients are different, would there be risks in getting both drugs? Also would this new version render FX-322 obsolete or can they both coexist and serve their own purpose?

So this new drug can reach around 4 kHz does anyone know how far FX-322 could reach by comparison?

I feel like it's going to progress similar to how when they made the first airplane and now we have fighter jets and newer versions being released. Also I'm sure when the first airplane failed to take off there was a lot of negativity and people saying we will never fly. Maybe one day Frequency...

Did they say how?

I still wonder if the new hair cells will easily reattach to the nerve.

Since FX-322 will be focused on regrowing inner hair cells instead of outer hair cells, it will mostly benefit clarity over volume/loudness.

Frequency Therapeutics Expands its Clinical Development Team, Adding Expertise in Inner Ear Physiology and Translational Science It doesn't seem like a waste of time if they are still hiring. And the open label trial shows some hope. "At day 90 following dosing, thirty-four percent (34%) of...

FX-322 has already restored hair cells in donated cochlea. I would say that's enough to have some faith in the drug.

They made the first airplane after many failed attempts and now they have fighter jets that can break the sound barrier. After FX-322 is released maybe one day they'll be able to make a better version that restores 90% of hearing with one dose.

Any ideas how much FX-322 would cost if you don't have insurance?

Does FX-322 work best for noise-induced hearing loss, or another type of hearing loss?

Anyone know where you can request a trial be held in your city? And is there a way to avoid the placebo and just get the real thing if you get accepted?

A few hundred pages ago, didn't they say that new hair cells automatically reconnect to the nerve and it's seen as a miracle in the scientific community?

Let's hope this is the case. The sooner, the better.

That would save a lot of time if they can go to Phase 3 soon. If the single dose trials all perform well, maybe FX-322 can reach the market by around 2024.

I see similarities to when the first airplane was invented. A lot of failures were endured at first until it finally worked. The same will happen with FX-322 and every new invention.

A lot of people are buying the dip, me included. I see these poor Phase 2a results as a step forward because it helped them gain a lot of knowledge that will allow for better results from new trials and eventually reach FDA approval.

I wonder what's the new timeline now for Frequency Therapeutics to repeat Phase 2a with single dosing?