Frequency Therapeutics — Hearing Loss Regeneration

[Lucifer]

I don't think you can infer that from these results. In fact, they admitted they may have screwed up the trial design as the placebo group reported improvements, which is unprecedented. If they did screw up, the whole Phase 2 is completely useless.

Omg I read it again and they stuffed up placebo. What does that mean for Phase 1B? Were the hearing improvements a fluke as well?

 

[RichieTheKid]

So since they did doses every week, what would happen if they did doses every month, would that change anything using their current delivery method?

This I don't know. I personally suspect the intervals will have to be even longer than one month, it's just my gut feeling. As for the delivery method, I personally think the Bionics Institute has the best idea, nanobots.

 

[Lucifer]

This I don't know. I personally suspect the intervals will have to be even longer than one month, it's just my gut feeling. As for the delivery method, I personally think the Bionics Institute has the best idea, nanobots.

Since Day 210 readout is sometime at the end of May, I do hope there will be good results at that time but after seeing that Day 90 experienced no improvements with additional doses, I don't think there will be positive results in May.

I wonder if those placebo patients got given FX-322 instead of placebo and that's why they experience hearing improvements.

 

[r34d1ng]

Omg I read it again and they stuffed up placebo. What does that mean for Phase 1B? Were the hearing improvements a fluke as well?

Phase 1b remains unaffected because it is a separate trial with a different design. They actually proved again that a single FX-322 injection is sufficient to regenerate some hearing.

This is not the end of the line. Stocks will tank (already tanking in pre-market); just let's wait a little longer for the full analysis of both trials. Plus, they are also conducting other two complementary Phase 1b (FX-322-112 and FX-322-113) due later this year.

 

[annV]

@Toby1972 you were right all along. Magic.

 

[Lucifer]

Phase 1b remains unaffected because it is a separate trial with a different design. They actually proved again that a single FX-322 injection is sufficient to regenerate some hearing.

This is not the end of the line. Stocks will tank (already tanking in pre-market); just let's wait a little longer for the full analysis of both trials. Plus, they are also conducting other two complementary Phase 1b (FX-322-112 and FX-322-113) due later this year.

Ok I did not realise they stated that in the current Phase 2a trial they proved it again that a single dose improves hearing but additional doses of FX-322 did not improve hearing.

Can they still advance to Phase 3 as they proved it in Phase 2a that a single dose of FX-322 still works or do they have to repeat Phase 2a with single dose only?

 

[r34d1ng]

Here is the PowerPoint presentation with more information on Phase 2a:

https://frequencytx.gcs-web.com/static-files/4a540e6b-b160-4e35-b487-5c82d264103b

 

[RichieTheKid]

Something I'm wondering about is synapses. What if FX-322 on its own may not show statistical improvements as much as a combination of hair cell and synapse restoration? I may be wrong but I'll wait for the smart guys to get on this.

 

[Philip83]

Not great news, but like some others mentioned, I also think we are simply kicking the can down the road. Not what we want, but it's not like the compound itself has been nullified.

However, weren't we also promised some group results on tinnitus and quality of life scores? I didn't see any of that in the presentation, which I guess isn't a good sign either...

But yeah, it's really odd how 4 doses ended up doing LESS than 1 dose. How is that possible? Is it actually because of how the compound works, or because they screwed up the data somehow? I guess we won't potentially know until late Q2.

 

[Cernuto]

It's not all bad.

"We now have two independent, single-dose studies showing a hearing signal with FX-322 and with statistically significant improvements in speech intelligibility. More single dose studies are underway to further understand the potential benefit of FX-322 in additional patient populations. Frequency is well resourced, and with the support of our collaborator Astellas Pharma, we will continue to advance development of potential hearing restoration therapeutics for the millions of individuals impacted by sensorineural hearing loss," added Mr. Lucchino. "We are very thankful to the people who participated in our studies and to the staff at all of the sites for their contributions and continued engagement, especially during the pandemic."​

Hang in there everyone, good things happen all the time.

 

[grate_biff]

Devastated...

So it must be the cell dividing molecule that is not working then?

 

[Dizzyhead888]

There is nothing said about tinnitus.

Their silence on tinnitus likely means it didn't help tinnitus either.

If tinnitus results were positive, they would have mentioned it to protect the stock from falling hard.

 

[tommyd87]

As for the delivery method, I personally think the Bionics Institute has the best idea, nanobots.

The Bionics Institute's nanoparticle method looks really really good in theory. It just needs to work in practice.

 

[r34d1ng]

Ok I did not realise they stated that in the current Phase 2a trial they proved it again that a single dose improves hearing but additional doses of FX-322 did not improve hearing.

Where did they state that? I think they are just comparing Phase 2a weekly injections to Phase1/1b single injection, not Phase 2a single injection to Phase 2a multiple injections. Might be wrong, though.

 

[Dizzyhead888]

Conference call at 8:30am ET today

How can we join it?

 

[tommyd87]

There is nothing said about tinnitus.

Their silence on tinnitus likely means it didn't help tinnitus either.

If tinnitus results were positive, they would have mentioned it to protect the stock from falling hard.

The tinnitus trial information was not a primary measure and I am actually almost certain that this data was not ever going to be released until the final trial outcomes get released.

So since they did doses every week, what would happen if they did doses every month, would that change anything using their current delivery method?

This is a good question. It could be best by trying to do dosing even every three months to allow growth to conclude.

Consequently I am wondering whether we would observe bigger improvements with FX-322 with a bigger volume of the medicine and also the dosing method used by Otonomy?

 

[Diesel]

It's not all bad in my opinion. Multidosing didn't work out, but single dosing still seems effective.

 

[Rubenslash]

It's not all bad in my opinion. Multidosing didn't work out, but single dosing still seems effective.

I agree, however they will probably have to do Phase 2 again with single dosing? This means another 2 years of delay...

 

[r34d1ng]

However, weren't we also promised some group results on tinnitus and quality of life scores? I didn't see any of that in the presentation, which I guess isn't a good sign either...

But yeah, it's really odd how 4 doses ended up doing LESS than 1 dose. How is that possible? Is it actually because of how the compound works, or because they screwed up the data somehow? I guess we won't potentially know until late Q2.

There is nothing said about tinnitus.

Their silence on tinnitus likely means it didn't help tinnitus either.

If tinnitus results were positive, they would have mentioned it to protect the stock from falling hard.

If the trial was actually misdesigned as they said, you have to rule out absolutely everything of the study. Every estimation would be useless because of bias.

 

[Stacken77]

Sorry, I've not been keeping up with this thread that much, but what does these results mean? Could it still give a meaningful improvement in the higher frequencies? I think i suffer from high frequency hearing loss.

 

[spacehunter]

Did we already see the extended audiogram changes? I mean it is plausible that more injections do not help with the lower frequencies, but maybe at least more injections benefit the higher frequencies...

I think the most important question will be whether they will commence Phase 3 regardless of the underwhelming results...

 

[Diesel]

I agree, however they will probably have to do Phase 2 again with single dosing? This means another 2 years of delay...

Nope. They say so in the press release. They're going to continue with a single-dose regimen. So they can go to Phase 2b/3 with a single dose drug that treat EHF + Word Score.

 

[scotty03874]

There is nothing said about tinnitus.

Their silence on tinnitus likely means it didn't help tinnitus either.

If tinnitus results were positive, they would have mentioned it to protect the stock from falling hard.

FREQ is going to single digits today. I would call that "falling hard."

 

[Pharz]

If multi dosing didn't work, and there were improvements in placebo, that means the results are not so reliable.

By the way I got a link to the conference. It is starting now I guess.

I enrolled through their website.

 

[Lucifer]

Do we know whether they can move to Phase 3 even though additional doses did not work? It seems a waste to repeat it again where they already know one dose of FX-322 works.

Why not just do one dose of FX-322 for Phase 3 clinical trial?

 

[Keith Handy]

It's not all bad in my opinion. Multidosing didn't work out, but single dosing still seems effective.

Seeing the positive can be an extraordinarily difficult task at times; thank you for doing the heavy lifting when I know you want to break down and throw things with us.

 

[Lucifer]

Nope. They say so in the press release. They're going to continue with a single-dose regimen. So they can go to Phase 2b/3 with a single dose drug that treat EHF + Word Score.

So once they have all the data from all the single dose trials to be completed before 2022, can they still move onto Phase 3 or would they need to repeat Phase 2a again with a single dose?

 

[Aaron91]

Since Day 210 readout is sometime at the end of May, I do hope there will be good results at that time but after seeing that Day 90 experienced no improvements with additional doses, I don't think there will be positive results in May.

I wonder if those placebo patients got given FX-322 instead of placebo and that's why they experience hearing improvements.

I gotta say I found it very strange they only left a week between each dose. I remember reading that it took 12 days for a colony to form. I also wonder what impact so many injections to the ear would have had. It's a stretch, but 210-day readout could be better.

It's not all bad in my opinion. Multidosing didn't work out, but single dosing still seems effective.

Market has reacted really, really badly though, albeit on low volume.

 

[Lucifer]

It's a stretch, but 210-day readout could be better.

Maybe, but I'm not going to keep my hopes up. If they can somehow still be able to go to the pivotal phase early next year with one dose of FX-322 after their other trials finish this year, this would be fine. They can always improve the delivery method later.

 

[Diesel]

I gotta say I found it very strange they only left a week between each dose. I remember reading that it took 12 days for a colony to form. I also wonder what impact so many injections to the ear would have had. It's a stretch, but 210-day readout could be better.

Market has reacted really, really badly though, albeit on low volume.

We'll see how they respond in the webinar at 8.30. They're going to disclose their interpretation. The stock will still not recover until there is a Phase 3 announced.