Frequency Therapeutics — Hearing Loss Regeneration

This makes me angry. However many of the participants are likely elderly so it makes sense...

I feel as if the FDA has become a personal enemy of mine:

Not only do their policies keep medicine from being exchanged between two consenting adult parties (buyer and seller), but they have forbidden anyone else to manufacture & sell COVID-19 tests.

If it weren't for this mandate, we would likely already be able to purchase take-home tests for a reasonable price. Which means people could identify whether they have COVID-19 before & after going out in public, and half the world wouldn't need to shut down.

As of now we have no way to self test, and the government botched their first batch. Now even medical professionals have a shortage...

This is just my personal opinion. I could go into a full blown rant about this but I understand that's not what this thread is for, and it would likely start a debate. I just had to express this after reading the above comments.

 

Yup, agreed. Btw I hope my post didn't come across as being dismissive or downplaying the severity of the situation!

 

1st vaccine candidate entered trials yesterday, I believe.

 

Hearing that coronavirus could last up to a year will affect the clinical trials for FX-322 and others.

Will they still operate clinical trials for FX-322 while the coronavirus is around or would we have to wait for a year or more until they can resume?

 

No one can know that right now bro. If I had to guess, I would say trials would continue conduction after a few months (probably 3+).

I think things are going to get worse through the next month and that the state/national governments will be forced to move back their quarantine timelines. This “3 weeks” shit is completely arbitrary and we absolutely do not have a handle on the situation at all, yet.

 

My guess is they will continue with current recruits but pause on initiating new doses in new patients. This will probably mean a few months delay minimum imo.

 

What a bad time for this virus to happen. Many of us are suffering and waiting to resume our lives while there are drugs in clinical trials for hearing regeneration which are now delayed due to the coronavirus. I hope they can still continue clinical trials while the virus is ongoing.

 

I would expect so as if they haven’t received their 4 doses of FX-322 and there's a delay in administering the doses this will affect the data that they collect for the clinical trials.

 

You've also got to think that the people who signed up for the clinical trials are probably pretty desperate/excited to receive treatment, considering there's no guarantee they're actually receiving the drug.

The researchers are probably equally as excited to get the drug to market.

So while clinical trials will likely be delayed, in my opinion just about everyone involved will be doing everything they can to keep trials going, or at least get them back on track ASAP. There's no reason to totally lose hope... That being said, I'm sure these trials are more delicate than I understand.

 

I think they were likely smart enough not to start with new recruits starting about a month ago but I worry most about how they will do audiograms (etc) on the people up to 5 months out but they probably have a means of meeting a skeleton crew at a facility to do this.

This would be a great question for them.

 

I would hazard to guess that any of the 4 different groups of patients have received their 4 weekly doses. At the extent, any of the most recent recruits will have them soon.

As far as the follow-up visits at 30, 60, 90, 120, 150, 180 and 210 days. There may. be. some. gaps. in the data.

Perhaps the opening of the additional locations will enable a greater population of participants to be tested; and the resulting gaps from missing follow-up data won't be as big of a deal.

Also, since it is mid-March, there may already be statistically significant follow-up data into the 90,120, and 150-day range from early participants.

Bottom line, there may be a delay, but they aren't without usable data for the FDA to review for Breakthrough Therapy status.

It's not a matter of IF, but WHEN. Let's sit with patience and be happy with that given the current circumstances.

 

Can’t wait for the Tinnitus Talk Podcast interview with Frequency Therapeutics to be released next month with @mrbrightside614 and @Hazel representing Tinnitus Talk.

I hope all the important questions we have will be answered.

 

Yah, gonna have to add some time to my cryosleep.

 

How many years could this SARS-CoV-2 pandemic set back research and progress on getting this to market? I hope none of the important researchers and staff get sick and die. That could be massive delays and lost knowledge

 

It's bad but not as bad as it seems - at least not yet. The media is having a hay day with this.

If you look up statistics, recovery rates are pretty high. It's showing to mainly be a risk to people with compromised immune systems (the already sick or elderly).

Only 112 people are known to have died from it in the whole of the United States. More than 90 people die every day from traffic accidents, to put it in perspective.

I believe if there are any delays, it will be months at most, not years.

 

To be honest, I am far more concerned about the country's reaction to this (everything shutting down) than the virus itself as far as FX-322 goes.

 

If only we could deceive the world into believing that hearing regeneration drugs were an essential component to treating the virus.

 

Quick questions my tinnitus was caused from loud music with earphones. Are my hair cells damaged? If so, will FX-322 regenerate the hair cells and get rid or at least reduce the tinnitus?

 

I really hope, my anxiety has been through the roof lately and affecting concentration more than my current difficulties with tinnitus.

 

If your hearing problems were noise-induced (the headphones) then it's almost certain that you damaged & lost some hair cells.

On this thread, the general consensus is that FX-322 will help if not completely cure tinnitus for most people with noise-induced hearing loss & tinnitus.

There is no way to guarantee that at this stage, however. We need Phase 2 trial results which are due in September, but might be pushed back due to the COVID-19 outbreak. Next month, there is also an upcoming Tinnitus Talk Podcast with Frequency Therapeutics head of research on FX-322, which should shine at least some light on all of this.

 

Same. I was getting productive again with my work for the 1st time in months, then this COVID-19 stuff happened.

Not having a clue when Phase 2 will be done or when FX-322 might hit the market has shaken me up a bit. Stay strong and try your best to focus on productive things! It's all we can do; don't dwell if you can help it.

 

You could have damage to your hair cells, synapses, or both. I think us noise-induced folks are going to need FX-322 in tandem with the synaptopathy drugs (OTO-413, PIPE-515, Hough Pill).

 

An extended audiogram can tell you if your outer hair cells are damaged. There is no reliable test for inner hair cells or synapses.

Noise induced hearing loss can damage synapses or hair cells. FX-322 is for hair cells but other drugs from other companies are hoping to address synapses.

 

@AtlasFainted coming from Spain, I am sorry to tell you you are wrong... Elderly are most affected by coronavirus, but young and healthy people are affected too. News won’t tell you that because panic would be even worse.

Please take care of yourself...

 

How did you get your tinnitus?

 

In Italy, they were also "putting it in perspective" not so long ago. Now, in Lombardy, 2 days of COVID-19 deaths accounts for more that a full year of road casualties.

 

I thought that one of the animated videos from Frequency showed that the drug also forms new synapses? Or is the thought that FX-322 won't help synapse damage if/where the corresponding hair cell is still active?

I must have missed something on this thread... I've been hoping that FX-322 would be a one-stop solution for me haha.

 

@mrbrightside614, @FGG, @Hazel, @Markku... Hi.

I know this is unscientific, but perhaps at the end of the interview, you could convey to Mr. Lucchino, or the powers that be, that there are a bunch of people on Tinnitus Talk who are quite desperate and have been following this company since its inception. These folks are clued up about hearing regeneration and some are facing Cochlear Implants, hearing aids, and many have high frequency hearing loss and are desperate for help. Tinnitus Talk members are already planning to share accommodation to help each other get treatment. We are huge fans and know hearing regeneration is our only hope. We are grateful for Frequency’s work and mission.

Shoot... This cochlear damage is hard work. Digging deep everyday.
Glad you hearing regeneration die hards are here...

 

I said "for now". For now, in the U.S, we haven't seen so many deaths as to think that the top researchers of Frequency Therapeutics will be wiped out by it.

If you disagree that's fine. I'm not saying that it's not dangerous, just that it's not the bubonic plague 2.0.

 

From what Frequency has said, the drug will also regenerate the corresponding synapses if hair cells are damaged but its primary function is a a hair-cell regeneration drug so it's probably not gonna be a complete slam-dunk from the POV of neural regeneration.