Frequency Therapeutics — Hearing Loss Regeneration

If there was good data and FDA allowed them to market their drug, I guess shares would increase significantly, because it would be the first drug for inner ear applications on the planet.

It would be a proof of concept for their platform.

But I have no clue what price it would reach.

If it was a widely applicable drug, I would see a bright future for Frequency Therapeutics. But as we learned, there is also a big chance that the drug might fail.

 

I'm hoping this is the case. If this drug fails, it might be a while before other companies try to treat hearing loss. There's a chance if this doesn't work, other companies might try to bypass the ear altogether before we get actual hearing regeneration.

But who knows for sure.

 

I have heard from an audiologist that he expects FX-322 to go to Phase 3. What's the consensus here? I dread the day the report comes out and mentions failure.

 

I hope the audiologist is right! But there's really no way for anyone to know at this point. I totally agree about the feeling of dread... I still remember how my heart sank the day the OTO-313 results came out.

 

I saw an ENT who told me OTO-313 was a success. He even saw it fixing people's tinnitus but then it was a total failure. Just be extra careful hoping for too much with FX-322.

 

I think the odds are 50/50 - a coin flip basically. On one hand Phase 2a failed, along with several of their other Phase 1b trials. Insanity is doing the same thing over and over again and hoping for different results.

On the other hand, they are targeting groups they think the drug helped. If it legit works, this narrowing of focus should help them push through the barrier of statistical significance. It won't be the holy grail of curing hearing loss that people thought it might be before Phase 2a, but proof it works will bode well for their platform and for FX-345.

 

If any of FX-322/FX-345 work and get to market, I believe they will only work to a limited extent. It could be something like a 60% chance of reducing your tinnitus by 40%.

It may work better on some people than it does for others. It may end up being viewed as simply a 'Prednisone type' treatment that can be effective outwith the acute phase.

 

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

 

That's where FX-345 could improve on, but yeah, those with severe hearing loss will be left in a lurch for a while. But I'm hoping it can restore 40 percent of their hearing back.

 

No, there are cochlear implants.

 

From the data we've seen in the previous studies, for those with moderately-severe hearing loss, FX-322 won't restore 40% of their hearing. At best it will help them with word clarity - giving those people 10-20% better clarity in word recognition (with a few people being super responders and having bigger improvements). It has not been shown to help with improving audiogram scores. It's been theorized that this may be because FX-322 is regenerating inner hair cells (IHCs), which deal with word clarity. Outer hair cells (OHCs) deal with amplifying sound.

As an aside, I recently saw a CBS report where they talked about a participant in the Phase 2a study who got "84%" of his hearing back. This came out on December 22, and since then Frequency Therapeutics' stock has surged 160%. I wonder if that report is giving people unrealistic expectations. It seems unintuitive that the drug would cause his hearing to come back all of a sudden and that no one else would have this kind of benefit. I worry that people are entering these trials who have problems unrelated to damaged hair cells (ie, nerve issue, mental issue, etc) and that that could wildly throw off the results. Imagine if someone like this were in the placebo group.

 

To me anyway, the pharmaceutical route is a while off a total solution. Just now I'm pinning my hope on a 'treatment' rather than a cure, i.e. Dr. Susan Shore's device.

In my experience, what will probably happen is FREQ will show promising data and/or an effective foundation to build a really successful treatment off. If this does happen, a multi-national major pharmaceutical company will most likely buy them and provide the necessary funding to really get a proper treatment developed. I don't think, right now anyway, this will be the cure we hope for, but I think it will be the proof of principal to perk up the ears of those with the required capital to inject into the development of cellular regeneration.

This is a relatively juvenile area of study right now. If FREQ show that they can actually regrow cells thought to be lost forever and show that it really is possible (regardless of whether it's a 5% improvement only at this stage) they'll really garner the interest of companies like Roche, Pfizer, J&J etc.

 

If FX-322 works to any extent, they have done something that has never been done in our history before. This would be a breakthrough. It would show that it is possible regenerate hearing. It could be a Pandora's box accelerating development in this field. This is what I really truly hope for; I am not expecting it to be the cure-all but if it works, it's the start of a new medical treatment in an area where currently none exist.

I really hope FX-322 gets through the clinical trial successfully. I don't care if it's not a cure, just that it works at all.

 

I can't agree more.

 

Absolutely! The most difficult thing is showing it’s possible and achievable! If they manage to regenerate working hair cells, it could quite possibly be one of the biggest scientific discoveries of our lifetime. I have everything crossed for this study going well!

 

I'll be happy about anything that doesn't end my hope for a treatment.

 

Frequency Therapeutics posted this video today:

 

The economy was roaring I will give you that, but FREQ was an over priced play that fell when investors found out this wasn't a get rich quick scheme. Hypothetically, the share will rise to that of its actual value, which with an effective drug should be somewhere around $20-$100 a share. I mean the way they are setting themselves up, they will have the only effective drug on the market resulting in having complete control of the market.

They will more than likely make it to $50 a share again assuming everything works out; but I would pull my money out if it reached that price. The competition is taking notes after all.

 

Wow, that’s promising!

 

Could someone post a summary? I can't get subtitles in my language

Thank you.

 

There's nothing new in it.

 

I think there are some apps out there that can translate the subtitles. Do a Google search or check your app store.

 

Yep. It's mostly an attempt to put a positive spin on results that are, at best, mild.

 

How do you feel about FX-345?

 

Any early treatment will be mild.

If they can prove that hair cells can be restored, that could be a game changer?

 

If there is proof of regeneration, that would be fantastic and the first time in a human cochlea.

I really pray for some positive results from where they might optimize the drug for all kinds of inner ear hearing loss.

 

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

 

Whether they had good results, or terrible results, the pitch would look exactly the same.

 

Who are they pitching to? Only possible answer: the stock market. They want to maintain the value of their individual stock holdings. Personally, I think just stfu, do the science, it works or it doesn't, let us know.

 

In an ideal world, yep.

But their scientists need to be paid. Their labs need expensive instruments. They use expensive chemicals. Etc, etc.

The value of the company is keeping them afloat in order to do the science.