Frequency Therapeutics — Hearing Loss Regeneration

I think @Zugzug's mention of it being a "sham" is a better way to look at it. In July 2020, when they took that $42MM private placement, they noted that the ARHL and Severe Phase 1B trials were intended to gain "additional insights regarding the patient populations and severity of hearing loss that FX-322 may treat."

Unfortunately, that insight points to ARHL as not a patient population that FX-322 is able to treat.

Fortunately, this excludes patients with ARHL from being included in any future trials, creating non-responders in treatment groups.

Source:

Frequency Therapeutics Announces $42 Million Private Placement

To me, it's good to see they're narrowing down the populations that FX-322 won't help, so the trials can better focus on the patient population that will show the best response to the drug. The population of people with hearing loss is MASSIVE, and the potential for multiple / varying underlying causes is pretty apparent. So, from a strategic perspective, even if it drug does only treat a class of patients with specifically SNHL Moderate-Severe, that is still a market in the MILLIONS.

Their goal is to get this thing to product. We all have potential access to it, even if we're not the primary candidate, it may provide some relief / healing.

Side note:
When was the last time a biotech company focusing on hearing loss had this many trials active / completed in a 4-year timeframe?

 

Damn. I’m losing my faith in Frequency Therapeutics.

 

I wonder if a delivery system like this (page 10 in the document) would make all the difference:

https://investors.akouos.com/static-files/cc432cb4-f189-44e7-af98-16e93b44ab93

 

FREQ stock:

 

Stock is gonna plummet.

 

Populations that take FX-322 and see improvements:



Seriously though, the ARHL fail is perhaps more of a market hit than anything else.

The big science hit will be if the Severe trial fails.

 

Will Frequency Therapeutics have any money to progress past 2023?

 

Come on... you quoted the first sentence, and then reacted, without adding in my second follow-up sentence about the size of the SNHL population... don't Fox News me bro...

 

As of today. No.

 

True, I hadn't really thought of that. Ideally they can load up their bigger trials with more responders to really knock it out of the park.

 

That's ideally the fast way to product for them with 1 dose.

Right now, it seems like patients with Moderate - Moderately Severe SNHL seem to be the baseline for an FX-322 responder. That's a 5-10 Million in the US alone.

If Severe shows results that let them add to that with 1 dose... that's probably the Phase 2 that they'll redo. If not, they'll probably focus on Moderate - Moderately Severe.

It will be interesting to see what they reveal about the Phase 2A... I would expect some detail on the 1-dose group from the Phase 2A.

 

Sorry, I was honestly imparting my own opinion with that joke (which is that I agree with you that the SNHL moderate-severe population is large, but the number of people that the current formulation will help is small).

Trust me, I don't want to be like Fox News. I will make an effort to never make that mistake again.

 

So, the age-related hearing loss trial was a failure. I guess it all comes down to the severe hearing loss trial.

And the press release said the results would be released later this year? So, I'm guessing in the fall.

 

For just once I think we'd all like to see some positive news on FX-322. Just give us one successful trial. That's all.

After years of torture, is that too much to ask?

 

I wouldn't call it a failure. The intention of the trial was to understand if FX-322 worked for ARHL. Turns out it didn't. That's good, now they won't be including people with ARHL in future trials.

There is positive news here. They are planning more trials. It's at the top of the press release:

"Company Anticipates Initiation of New FX-322 Phase 2 Study in H2 2021"

Everyone is so fixated on that Phase 1B that was a total shot in the dark, they're missing that key detail.

Frequency Therapeutics Provides Business Updates and Reports First Quarter 2021 Financial Results

 

So, they plan on conducting another trial later this year? Will this be just for mild/moderate hearing loss?

 

Damn they're not wasting a second.
Two phase 2 trials in the same year.

 

When you're nearing the end, you don't wait around before throwing your hail-mary pass.

 

Exactly! They'll have enough patient population data after the Severe Phase 1B, and learnings from the Phase 2A flop, they need to rip off the bandaid and get that last single-dose Phase 2 out of the way!

 

Well it's really great news that they can identify all the people it doesn't help.

I mean I thought that the science was... You lose hair cells, you lose hearing, FX-322 grows hair cells, you get hearing back.

But now we know if you got mild hearing loss, nope, it does nothing... If you're old, nope, it does nothing...

One more trial to go but I guess it's going to be a nope, it does nothing. Call me cynical but a few people have got extremely rich, maybe if they were as good at science as they were at business / marketing they would have got somewhere.

This is really quite depressing if Frequency Therapeutics can't get it right with all the great team and financial resources they have. What hope is there?

It really seemed like Frequency Therapeutics had the answer but I have to say my faith in them and belief in the science is gone. If hair cell loss was the cause and FX-322 worked, it would work. So either the science is wrong or FX-322 doesn't work.

Must be nice having made millions by delivering absolutely nothing.

I think I just need to give up expecting anything and give up on these forums (no offense, the forums are great) and the endless discussions about the same stuff over and over. Everyone slags off audiologists but they are right; there is nothing and there's no point in looking. If there ever is a treatment or cure that actually works, the whole world will know. You can go back years on here and the same things were being discussed. I don't see any progress

I mean I was watching a video on YouTube the other day from one of the tinnitus conferences from 2019 where the leaders in tinnitus research were saying it's good to talk to tinnitus patients to try and understand what they want... They don't know... We don't want this sound in our head. We want hearing function improved. It's not hard to understand what we want and the fact that leaders in research in the field don't know that says it all.

I hope I'm wrong. I really do. I hope they will announce in 6 months that the severe hearing loss trial was a huge success, FX-322 works and will help people.

Good luck to everyone suffering. I hope all of us can figure out how to survive this because help is not coming.

 

I don't think that info will be of much value since while they technically received 1 dose, they also received 3 doses of placebo that jacked up the chemistry of the ear.

 

You don't need to be so melodramatic. FX-322 is a forum favorite but they're hardly the only one, and there's a myriad of companies getting in on the action month by month.

 

Then there still IS hope.

 

Definitely a fair point. In a sense, it's better to know. Phase 2 repeat will be kind of frightening if the Severe trial is a bust. Actually, it will be frightening even if it's a boom.

I'm diversifying my hope by adding OTO-313, OTO-413, SPI-1005, and PIPE-307. Far healthier.

 

I don't understand how anyone can think otherwise. Are we supposed to believe that hearing loss is the only field of medicine that will never ever have any developments?

I find that harder to believe.

 

I agree. Science and technology are advancing at such a rapid pace. I truly believe such things like AI are going to solve this riddle.

Mass Eye and Ear is working on stem cells to reverse blindness right now.

 

It will eventually. AI and brain implantation will help, microscopy and cellular biology advancements along with other nano machine and small molecule advancements will also progress the field. Hearing regeneration and curing noise induced tinnitus is more of question of when rather than if. Especially with the influx of COVID-19 tinnitus people.

 

I'm definitely keeping an eye of PIPE-505 and OTO-413... I'm starting to think for the cases of noise induced hearing loss + tinnitus (looking at you, acoustic trauma crowd), synaptogensis treatments may have higher odds of providing more substantial relief.

I still think we're going to ultimately need both, but one might give slightly more improvement than the other initially.

 

It's too bad they can't look inside our ears and take an image of the cochlea. I would love to know if it's my synapses that are broken, or if it's dead hair cells.

 

I'm just not seeing how the severe hearing loss trial is going to show any major improvements.

This was disappointing. We can now limit the type of person it helps and the amount it helps if the severe hearing loss trial is successful.

I'm having an issue with this quote:

“To date, Frequency has shown statistically significant hearing benefits in multiple, independent FX-322 studies"​

The benefits just aren't there. Even those that had improved word scores, many dropped in the follow up visits and the hearing restoration aspect is very limited.

Instead of more trials we need Frequency Therapeutics to figure out how to make it more effective, if it is even possible.

I think they will end up running out of money. Hearing loss was only one application of their advancement. I doubt anyone will give them money to continue, so we will never know what other potential benefits PCA will have.