Frequency Therapeutics — Hearing Loss Regeneration

[Chad Lawton]

I can't believe no one asked questions! My question was the only one!

I asked:

When can we expect the severe study results? And how confident are you that the moderate and severe hearing loss patients will respond to the drug?

(You have to watch the presentation to see his answer)

I would have asked one had I not goofed and missed it with the wrong time zone calculation. I would have asked if they anticipate excluding mild hearing loss patients in future trials based on their lack of response in stage 1 trials.

Also, Lucchino said something along the lines of "expanding the hearing pipeline. What this means, I'm not sure. Maybe another drug or program in the works?

 

[Street Novelist]

I can't believe no one asked questions! My question was the only one!

I asked:

When can we expect the severe study results? And how confident are you that the moderate and severe hearing loss patients will respond to the drug?

(You have to watch the presentation to see his answer)

You have to be registered to watch it. Can you just give us the answer?

 

[ajc]

When can we expect the severe hearing loss study results? And how confident are you that the moderate and severe hearing loss patients will respond to the drug?

You have to be registered to watch it. Can you just give us the answer?

The answer is:

"We expect to have the severe results in the second half of this year. We have seen a response in the moderate to moderately severe hearing, I can't say what the results will be obviously, but we're confident in the direction we're going."

 

[Street Novelist]

The answer is:

"We expect to have the severe results in the second half of this year. We have seen a response in the moderate to moderately severe hearing, I can't say what the results will be obviously, but we're confident in the direction we're going."

Ok... cool, cool. Well, the second half of this year will be interesting. Not only will we get the results of the severe trial, it sounds like new trials will also begin, with moderate to moderately severe being the most likely.

 

[Gb3]

I can't believe no one asked questions! My question was the only one!

I asked:

When can we expect the severe study results? And how confident are you that the moderate and severe hearing loss patients will respond to the drug?

(You have to watch the presentation to see his answer)

I watched it after.

How come you didn't ask about tinnitus?

 

[Diesel]

How come you didn't ask about tinnitus?

That would have been a dud question, they haven't released any data on tinnitus so he wouldn't have commented on it other than saying, "we anticipate releasing more data on that in the future..."

 

[VeryUnfortunate]

You have to be registered to watch it. Can you just give us the answer?

For future reference, for the Frequency Therapeutics webcast website you can register with any name, company name and e-mail address. Just make up a company name and you can go ahead and watch.

 

[ThomasRobert]

I watched it after.

How come you didn't ask about tinnitus?

In 7 days you can ask them at the upcoming Goldman Sachs Conference.

 

[kiki]

1. On the Jefferies webcast just now
2. In the June Investor Presentation: Page 18

"Anticipate activating additional FX-322 Phase 2 placebo-controlled studies in H2 2021"

https://investors.frequencytx.com/static-files/5805963a-0f32-449f-8c29-ba6b7356cd0a

Based on the Q&A, it sounds like Lucchino is pretty confident that Moderate -> Severe SNHL is going to be the target patient population for one of the "New Phase 2" studies.

I wonder what another one might be?

Another Phase 2 I would like to see is:

A clinical trial in which the concentration is increased or the component concentration is adjusted.

Alternatively, a clinical trial of multiple injections at longer intervals.

 

[Diesel]

Another Phase 2 I would like to see is:

A clinical trial in which the concentration is increased or the component concentration is adjusted.

Alternatively, a clinical trial of multiple injections at longer intervals.

If I understand the FDA rules, changes in concentration would mean a reformulation and require a whole new safety trial.

Since they've consistently been reconfirming that they're sticking with single-dose, I don't see a longer interval multi-dose Phase 2 in the future either.

I could see them doing a single-dose Phase 2 for Moderate-Severe hearing loss. And possibly another Phase 2 for a specific subcategory consistent with Mild hearing loss. Could be something like speech-in-noise, for example.

Maybe they'll do a Phase 2 where both ears get a single injection? ... I'll wait while everyone tells me that's a terrible idea.

 

[Gb3]

That would have been a dud question, they haven't released any data on tinnitus so he wouldn't have commented on it other than saying, "we anticipate releasing more data on that in the future..."

Correct. I just put N/A.

 

[Joeseph Stope]

I would have asked one had I not goofed and missed it with the wrong time zone calculation. I would have asked if they anticipate excluding mild hearing loss patients in future trials based on their lack of response in stage 1 trials.

Also, Lucchino said something along the lines of "expanding the hearing pipeline. What this means, I'm not sure. Maybe another drug or program in the works?

Duh! View that pep talk that Lucchino gave yesterday. 10 minutes in — was it study FX-322-111? — he seems to be saying or portraying that mild SNHL got some positive results. Correct me if I'm wrong.

Well, I hope they can do something with the mild cases of hearing loss. My hearing loss is pretty mild, but my tinnitus is driving me around the bend. Especially since this COVID-19 Pfizer jab. And there's one more to go.

But the way thing are going we could be in a permanent or perennial (yearly) vaccine world now with all the variants coming in.

 

[Joeseph Stope]

You obviously haven't been paying attention to the thread--namely the part where someone tried to essentially banish me from it. That might make one defensive, don't you think? Anyway, I have to imagine most reading this thread do not want to read all of this member on member drama. It's all noise.

Bring it on! In this corner we have heavyweight champion GlennS etc.

You (both) raise a really interesting point .... it could be a philosophical question really.

In my case, my tinnitus onset dates back to Easter 1992 and after trying all the standard therapies and the a few outsider therapies I got the advice: "If you believe all these adverts for therapies, you'll be running around like a headless chicken (and broke). Wait for the hard evidence that a therapy actually works."

Fast forward to 2021, and the world has come on a bit. The medics can now access the cochlea with intratympanic injections. That's quite fantastic. And as this site shows, the tinnitus community is literally breathing down the backs of the researchers and the clinical trial test members.

So the ground has shifted a bit. Still no cure. You could toss a coin now as to whether to "believe it when you see it" — like Jazzer for example — or you could take a ringside seat and watch each new development. Flavour of the month is now OTO-312 — and yes, there even by watching, you will be running around like a headless chicken (or investing your hard earned savings in the hope of cleaning up).

It certainly makes life more interesting though. And everyone needs a little hope.

 

[Jrblovsky]

If I understand the FDA rules, changes in concentration would mean a reformulation and require a whole new safety trial.

Since they've consistently been reconfirming that they're sticking with single-dose, I don't see a longer interval multi-dose Phase 2 in the future either.

I could see them doing a single-dose Phase 2 for Moderate-Severe hearing loss. And possibly another Phase 2 for a specific subcategory consistent with Mild hearing loss. Could be something like speech-in-noise, for example.

Maybe they'll do a Phase 2 where both ears get a single injection? ... I'll wait while everyone tells me that's a terrible idea.

So what happens when you only have problems in one ear? I guess I'm out.

 

[Diesel]

So what happens when you only have problems in one ear? I guess I'm out.

Not sure what you mean?

If there were a bilateral loss hearing trial where both ears are injected, you wouldn't be able to participate. If the drug were approved, it wouldn't matter.

 

[Lucifer]

Duh! View that pep talk that Lucchino gave yesterday. 10 minutes in — was it study FX-322-111? — he seems to be saying or portraying that mild SNHL got some positive results. Correct me if I'm wrong.

Well, I hope they can do something with the mild cases of hearing loss. My hearing loss is pretty mild, but my tinnitus is driving me around the bend. Especially since this COVID-19 Pfizer jab. And there's one more to go.

But the way thing are going we could be in a permanent or perennial (yearly) vaccine world now with all the variants coming in.

With mild hearing loss cases FX-322 should work. The reason why they are limiting it to moderate-moderately severe hearing loss patients is because it would be easier to prove if FX-322 works whereas when testing mild hearing loss patients they have already reach the ceiling effect.

In the previous trial they have proven that FX-322 works with moderate-moderately severe hearing loss patients but they need to prove it with more people.

 

[Jrblovsky]

If there were a bilateral loss hearing trial where both ears are injected, you wouldn't be able to participate. If the drug were approved, it wouldn't matter.

True. Hopefully one of these actually work and soon. This really blows.

 

[Gb3]

So what happens when you only have problems in one ear? I guess I'm out.

It's just for clinical purposes. It's easier to get streamlined results.

 

[ThomasRobert]

Going through recent posts, I just want to make sure we are all on the same page...

 

[Diesel]

Going through recent posts, I just want to make sure we are all on the same page...

View attachment 45260

Wait... Did you just overlay that on an audiogram? WHAT. HAVE. YOU. DONE?

Also...

There's no evidence that FX-322 does/doesn't work on Profound hearing loss.

 

[GlennS]

I just want to make sure we are all on the same page...

We're not. The whole controversy surrounds whether it truly "works" or not.

Even if we factor in the safety trials, I want to see a) repeatability, b) audiograms, and lastly c) testimonials (related to tinnitus in particular).

Classifying anything as "works" is just way too much of a gross simplification at this point.

 

[ThomasRobert]

Wait... Did you just overlay that on an audiogram? WHAT. HAVE. YOU. DONE?

Also...

There's no evidence that FX-322 does/doesn't work on Profound hearing loss.

Yes, it was an edit of an audiogram... Many members here are confused on which level of hearing loss FX-322 has the potential to treat.

Yes, I agree, there's no evidence that FX-322 does/doesn't work on Profound hearing loss. But it was discussed earlier that in Profound stage most probably support cells are dead.

 

[Gb3]

Going through recent posts, I just want to make sure we are all on the same page...

View attachment 45260

What do you mean by works?

 

[ThomasRobert]

We're not. The whole controversy surrounds whether it truly "works" or not.

Even if we factor in the safety trials, I want to see a) repeatability, b) audiograms, and lastly c) testimonials (related to tinnitus in particular).

Classifying anything as "works" is just way too much of a gross simplification at this point.

FX-322 works. To see it in Audiograms, you have to wait longer while they modify the delivery method.

 

[ThomasRobert]

What do you mean by works?

It means the environment and condition of the support cells in the ear are healthy enough for the drug to carry its intended purpose.

 

[ThomasRobert]

Maybe FX-322 does not reach the Outer Hair Cells. That could be the reason we are getting a response on word scores only since Inner Hair Cells are responsible for word scores.

For example, here we could see the drug just flowing over the Inner Hair Cells, and not reaching the Outer Hair Cells:

 

[Diesel]

Maybe FX-322 does not reach the Outer Hair Cells. That could be the reason we are getting a response on word scores only since Inner Hair Cells are responsible for word scores.

For example, here we could see the drug just flowing over the Inner Hair Cells, and not reaching the Outer Hair Cells:

View attachment 45265

The cochlea is essentially liquid filled. The drug diffuses into it through the round window membrane more like dye in a glass of water. That's why they show it as a gradient in the diagram.

 

[Kleiner]

Maybe FX-322 does not reach the Outer Hair Cells. That could be the reason we are getting a response on word scores only since Inner Hair Cells are responsible for word scores.

For example, here we could see the drug just flowing over the Inner Hair Cells, and not reaching the Outer Hair Cells:

View attachment 45265

There is no chance that FX-322 will reach IHC but not OHC. However, there may be differences between OHC and IHC so that one grows and the other does not.

The first step is to prove that FX-322 has at least a minimal therapeutic effect. Current results are not sufficient.

I hope, however, that we will learn more in June.

 

[Aaron91]

There's no evidence that FX-322 does/doesn't work on Profound hearing loss.

IIRC there's research showing that you lose your support cells once you reach profound, so there's no cells to proliferate and differentiate into OHCs and IHCs by that point, hence why FX-322 doesn't (in theory) work and presumably why they're not even bothering with this group in the clinic.

 

[Ben Winders]

This is probably my first post in this huge thread. I've been lurking.

Am I right in witnessing that the general sentiment is back to being more positive about FX-322?

But before, earlier this year, when the initial study results on repeat dosing were published, everyone was completely devastated...?