Frequency Therapeutics — Hearing Loss Regeneration

Not likely from a firm running on investor cash facing regulatory compliance from the FDA and SEC.

 

Ok, so what you're saying is that they don't get any hard science until the END, aka, Spring 2021, which is what I thought... However, they can be receiving less formal updates throughout the trial along the lines of "some patients have seen improvement in their hearing and tinnitus, looking good" and the doctor/ENT saying "half the patents I've seen have improved hearing"?

So basically, more "under the table" and unofficial statements?

 

Carl LeBel already said on the Tinnitus Talk Podcast that he’d heard positive things from ENTs regarding tinnitus from people who had FX-322.

 

Right, but he heard those things at the conclusion of phase 1.

He specifically said they got no info during the trial.

 

Yeah I got that, I was just pointing out to the person that we did have that level of confirmation in case he didn’t know already.

 

Also that’s incredible, if he’s hearing that after one dose, I can’t wait to hear what he hears back after 4. Especially since, and correct me if I’m wrong, tinnitus is an outcome for this one.

 

I contacted Astellas Germany - I live near Munich - if there will be a study in Europe.

They replied:
"We can only recommend that you visit https://clinicaltrials.gov/.
This way you can see where European studies are planned. "

Nothing is planned - that's bad.

Strange that they sent me a long email with a lot of secondary things (privacy, etc.) but didn't reply with something more concrete.

 

Sorry in advance for the ignorance, I have no idea how these things work.

When (if, knock on wood) Frequency Therapeutics releases FX-322, how would I go about getting it? Do I simply visit my local ENT and request the injection? Would I have to wait long for them to receive FX-322?

 

There might be some off the record discussions, however if there was then this would be done very privately. I reckon that Frequency Therapeutics probably doesn’t know what is happening in the trials however. With how we have seen Frequency Therapeutics wanting to fully comply with the FDA requirements, I don’t think that they would do a at thing that would put the trial at risk.

Though I am thinking that they must think positively about FX-322 as otherwise they wouldn’t be willing to instigate further trials to test it if they didn’t think that it was going somewhere.

 

I thought the last patient would have received the final dose this month because they have to review the patient at certain times up to 210 days. If the last patient were to receive the dose in June 2021, the results would be delayed until the end of 2021?

I thought the results for Phase 2a were to be released end of May 2021 according to the ClinicalTrials.gov website?

 

Are we expecting to see any data about tinnitus - or just hearing - when they release phase 2a results?

 

They're not even done with the current trial, nor are they likely to tell you when they plan on hosting the trial before they notify ClinicalTrials.gov. That's important info that can influence stock price, as well as company perception. They're not just going to tell some random that emailed them before they tell the public at large. They're literally telling you to watch the website so when they release the plan, you can access it with everyone else.

 

You're reading that completely wrong. There are plans, they're just not public yet - for a variety of reasons. If you need something to put your mind at ease, check out this quote from a doc Frequency Therapeutics released: [1]

So Astellas will pay Frequency Therapeutics $90 million at the start of Phase 2b. My assumption is Phase 2a has to finish before Phase 2b can start. And the results of Phase 2a could wildly change what happens next. Astellas isn't going to fork over the 90 million until they need to.

[1] https://www.sec.gov/Archives/edgar/data/1703647/000119312520127683/d924569dex991.htm

 

Just my opinion but I reckon they will skip phase 2b and go to phase 3.

The countdown to April/May 2021 is on.

 

I'm also including the new Phase 1b trial for presbycusis.

 

I had a feeling you were talking about that but just wanted to make sure.

 

They’ll tend to want proof that the treatment is going to give them a return on their investment which meaans that Astellas will want to see that it works first.

I don’t think they will skip over phase 2b. If I’m accurate, phase 2b might be either one of:

- The phase 2 trial of the age-related hearing loss trial or
- Frequency Therapeutics may be required to run a phase 2 trial in Europe to comply with their approval standards first.

Looking at things, I actually think that the phase 2b trial will refer to age-related hearing loss trials. Taking a look at the medicine approval rules in Europe it is now evident that America and Europe have agreed to mutually recognise each other’s trials. Thus Frequency Therapeutics can run the age-related hearing loss trials overseas and not have any issues in getting them recognised in America by the FDA.

I still do not think that running a phase 2b trial for age-related hearing loss will necessarily affect the release of FX-322 for the non-age related hearing loss trial necessarily either. Essentially if the FDA is ultimately going to consider the non-age related hearing loss treatment and the age-related hearing loss treatments separately then there is no reason that they will not consider an application made by Frequency Therapeutics to obtain compassionate use after the phase 2a trial for non-age related hearing loss is completed. Hopefully this trial turns out successful and hopefully compassionate access also gets granted.

 

I wonder what if they already long ago envisioned a separate trial for age-related hearing loss and hence trials phase 1a and phase 2a are SNHL and phae 1b (and possibly 2b, 3b) is to test efficacy of age-related hearing loss treatment. The only difference being participants' age, kind of makes sense as one would expect regenerative medicine would work better on younger population and yet the older population is a far larger market.

 

@FGG during the injection, do you have to tilt your head sideways or lay on your side to improve the osmosis of FX-322?

 

Break dance with just your head, centripetal force. That's why they exclude people with vestibular disorders from the trial .

 

You mean like this?



I always thought 15 minutes of this could get the drug inside the whole cochlea:

 

Can someone compile a full fact list for FX-322? Sample:

 

Frequency Therapeutics Announces Expanded FX-322 Clinical Development Program and Upcoming Day-90 Phase 2a Analysis

https://investors.frequencytx.com/n...erapeutics-announces-expanded-fx-322-clinical

Buckle up! 2021 is going to get really interesting!

 

Some of those "facts" are (imo) wrong assumptions or not put in proper context.

E.g. If word score improvements were due to a poorly controlled trial that allowed lip reading (which is extraordinarily unlikely since approved contract labs ran the study, not Frequency Therapeutics -- to give you an idea one study center in North Carolina is running Frequency Therapeutics, Otonomy and Pipeline Therapeutics), then why do they not lip read for the control ear in the same patient?

I.e. people had no word score improvements in their other ears which were also tested.

Also the 92% figure comes from biotech as a whole is heavily weighted towards cancer drugs and things like Alzheimer's which have a very high failure rate (I believe only 1 or 2 Alzheimer's drugs has been approved in the last 10 years). I don't think you can use that to estimate an entirely new platform.

 

I would suggest if people want to know the best verified information about FX-322, they review the following on Frequency Therapeutics' website:

- Investor Presentation
- Recent SEC filings incl: 4-K and 8-K
- Science Publications

 

Yes, these are from my understanding (my own humble opinion) and from what I have read so far.

We will not doubt your details for sure... It would be great to compile all "verified" facts about FX-322 and list them here...

 

Hmm, they wouldn’t publish after 90 days if they didn’t see something in the current trial... Trials for severe and age related hearing loss are also very positive indications.

 

Frequency Therapeutics already does a pretty good job of that in their monthly presentation:

https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1

It covers all of the basics, has illustrations, and is pretty easy to get through. Since it's put out by the company itself, it's also much less likely to contain false info or unwarranted speculation that could seep into any community-based fact sheet.

 

I don't get it. I thought this phase was double blinded. How can they release information before it's completed?

 

I had this thought this morning after realizing the completion date for the age-related phase 1 trial is June 2021, insurance coverage may not be the primary motivation for adding this trial after all.

I suspect what might be going on is that they plan to add this cohort to an upcoming (pivotal) phase 2b/3.

It would make recruitment vastly easier and quicker.

I think the 90 day read out could also be to potentially prepare Astellas for the next trial. I do wonder when the "blinding" lifts and maybe this is a way for them to get an early read.