Frequency Therapeutics — Hearing Loss Regeneration

A look at what's next for Frequency Therapeutics:

Frequency Therapeutics: A Look At What's Next After A Disappointing Data Readout

 

What's next is the same like Autifony... go bye bye.

@FGG you owe me a million dollars, as you lost the bet of a cure in the next 10 years.

 

That article was written by a Biotech Investor, very well written but it's just stock talk.

 

I think it's only been a few months since you asked if I thought there would be a cure in 10 years.

I don't have a million dollars btw and probably you don't either (but you might).

 

Yes. And Frequency Therapeutics has already flopped. Start saving now.

 

Even if that were true (which it isn't), they're not the only ones.

 

You asked for my opinion, not a bet. The drug is still viable btw.

 

FX-322 has done well in single dosing trials. People on this thread are so pessimistic because of the failure of the Phase 2a trial.

The failure of the Phase 2a trial was due to weekly dosing. If they had done the trials again with a single dose of FX-322, it would have had positive outcomes in the improvement in word scores and audiograms which would resulted in FX-322 going to the pivotal phase.

 

I'm still trying to figure this out. It seems there is still a ton of talk about FX-322 and Phase 1.

I don't have a medical background but doesn't this drug qualify for scrap status?

It seems there is a lot of thought that a single dose will help.

Have they announced a new dosing schedule or what am I missing?

This drug seems DOA.

 

That and several clinical trials...

 

This suggests otherwise (it was posted by someone else earlier in this thread):

Frequency Therapeutics: A Look At What's Next After A Disappointing Data Readout

On another note, experimentation is an essential part of any tech development, biotech included. I don't understand what all the fuss is about concerning the obvious imperfection of a drug while it is still in development and testing.

 

In addition, I think Phase 2a may not be a complete failure.

In the final readout, I think there may be some good results in WIN, PTA, TFI, etc.

Even if it is an "individual anecdote" rather than "statistically significant". I hope you can see that it is working.

 

That's a pretty huge assumption. Probably better to hold off on saying those kind of things until the full results Q3.

Because people were pulling heavy for this drug to pass Phase 2a with flying colors, which obviously wasn't the case since now the efficacy of the drug itself is being brought into question.

 

If I felt certain that FX-322 was dead, I wouldn't keep coming to this thread just to say so; I suspect at least some of the absolute pessimists (the "no hope whatsoever" contingent, as opposed to the merely critical) are still looking for hope here, but refusing to say so out of some kind of self-protective instinct.

 

Still don't get why you all keep wasting so much time and energy with people who only contribute nonsense. Use the Ignore function.

 

Evidence supporting FX-322 still having a path to approved product:

1. Phase 1B for ARHL in-progress.
2. Phase 1B for Severe SNHL in-progress.
3. Firm announced in late March that multi-dosing at 1 week intervals wasn’t effective, plans to move forward as a single dose drug.
4. CEO states in investor presentation in April that the firm is planning to announce additional FX-322 trials 2H/2021.
5. Three Separate Trademarks files for Hearing Loss Treatment by firm.

Other speculation:

6. Phase 2A individual data unreleased, but may shed detailed insight on where they may go next with multidosing.

 

I see you've been a member here since 2012. That's almost 10 years! I don't blame you for being pessimistic. It ain't a fun ride at all!

Help is on the way... hang in there.

 

It might help with extremely high frequency tinnitus, high frequency hearing loss, and it might help with word scores. That is all we know for now. It is not going to be the cure for hearing loss as some people originally thought. Everyone had different expectations on what they wanted the drug to do, probably based on their personal conditions. This is probably why some people are more pessimistic than others.

 

Limitations of the delivery gel, not the drug itself.

 

So by next week Frequency Therapeutics will announce new clinical trials aside from the 111, 112, 113?

 

2H/2021 = Second Half, 2021... so anytime between July 1 and December 31.

 

About OHCs, I know that unlike IHCs their stereocilia enter the tectorial membrane, what happens in adulthood if an OHC grows?

Apparently, in rats, there are slots in the tectorial membrane where each stereocilia can "sink", but I don't know about humans.

Could this be a reason for the limited audiogram scores? What if the stereocilias did not manage to sink into the membrane?

 

Well hopefully they can figure it out but I'm not holding my breath.

 

You will have to point me to the rat study you are thinking of but normally it's like this (easier to see in cross section drawing):



If you are going by histology photos, the missing "slots" you see in the Organ of Corti on histology are present for both OHCs and IHCs. It's just easier to appreciate on OHCs because of the way the rows are laid out.

Unless rats are somehow very different but I have never come across that before.

 

I didn't find the study, I will try again tomorrow
But I found some pictures on this website : http://www.cochlea.eu/en/cochlea/organ-of-corti/variations



In the rat, the stereocilia appear to have "slots" in the tectorial membrane.
The question is : The new OHCs (if so) fit into the membrane properly ?

I think this is a detail they considered at FT, I hope

EDIT : On the same website, it's said that human stereocilia interlock a little bit in the tectorial membrane (10-20Khz) and almost not at lower frequencies
http://www.cochlea.eu/en/hair-cells/outer-hair-cells-ohcs/externes-couplage

 

That's really interesting. The rats' hearing did improve in pre-clinical, so I imagine this doesn't apply. Very informative though.

 

Phase II results, with almost 100 participants, were devastating. FX-322 showed no signal at all, with no difference between drug and placebo. FX-322 simply worked no better than sugar water.

Phase I, with a handful of participants, had a few that responded positively.

In drug development, larger, later-stage trials are more meaningful than earlier, smaller trials. That's why experimental drugs that show enough promise in early trials to proceed to next-phase trials can still flame out with the clarity of larger numbers. A drug that might show promise in a study of 10 people, might, when distributed to 1,000 or 10,000 people, demonstrate no particular benefit at all. AM-101, for example, had a positive Phase I and Phase II trial, but still flamed out in the middle of Phase III.

I think there's a misunderstanding among some in this thread that a positive Phase I counterbalances a negative Phase II. It doesn't. Phase II, with significantly more participants, is significantly more meaningful, and after FX-322 failed Phase II, the 3 participants who did well in Phase I are no longer as compelling. The more robust data of Phase II suggests that there may be reasons other than FX-322 to explain why Phase I responders did so well, reasons we may never know.

That said, I don't think it's DOA either.

Diesel provided a reasonable list of possibilities that still exist above. Frequency Therepeutics is also running additional trials that might replicate the good results seen in Phase I. After all, while we don't know for sure that FX-322 helped those 3 people in Phase I, we also don't know for sure that it didn't. Frequency Therepeutics also provided theories why Phase II failed (other than it just didn't work), although we don't know, and maybe they don't yet know, if they're true. But perhaps they can right the ship with better trial design. And as others have noted, failure is part of progress - just means it takes a little longer to achieve.

 

If I understand this correctly, it also seems important to keep in mind that the Phase I and Phase II trials were essentially different treatments a

ltogether given the difference in delivery (single versus multiple injections). Without holding everything constant, the trials are not comparable, which means that we're still essentially waiting for a proper test of the Phase I results using a larger sample size.

Honestly, I don't know how/why/wtf they were thinking during design of the Phase II trial. Even if the Phase II results looked "good", hopefully the FDA would have caught that design flaw and required another Phase II. There's no sense in sticking things in our ears that aren't tested as rigorously as possible.

 

As @Ehren M alluded to above, they tested two very different dosing strategies. If rapid multi-dosing is problematic as per the company, this is a correctable issue but it doesn't mean you can swap out the trials, though. They definitely need to repeat Phase 2 (which most people on this thread who believe in the drug acknowledge).

 

Chief Development Officer and Chief Scientific Officer each buy 30,000 shares!

Can someone tell me this is a good sign and not just the usual answer of a 10b5-1 plan!?