Frequency Therapeutics — Hearing Loss Regeneration

An interesting point. What good is all the PR to a company. The best PR is good trial results. Then again if the company thinks that it's onto a winner and they just need a little more time to tweak the molecule in question... so the PR might help with issuing more stock?

 

I will give FX-322 the benefit of the doubt. If by next year the repeat Phase 2 results don’t show positive outcomes then it will be a done deal.

The haters here will probably give up on this company if the results aren’t good for the severe hearing loss trial.

 

Afterwards, we can only hope for Otonomy.

 

So what does this mean for us?

 

It means "Wait".

Sometimes I think I must be genius.

 

The severe hearing loss trial can fail, but in that case it will be Phase 2 (re-challenge) without severe hearing loss. The final conclusion is whether or not the re-challenge will produce good results.

 

Either Otonomy or PIPE-505.

 

Seriously no offense but some of the questions on here are a bit stupid.

 

Well, I think that creating new hair cells is one side of the medal. The other side is the reconnection between hair cell and the auditory cells and nerves... Herein I see the problem... I've once read that in principle nerves are able to regrow and regenerate, but very, very slowly. But maybe with the new techniques in medicine there might be a solution in the future.

 

Don't you think Ebselen (SPI-1005) can bring us some relief?

 

Neurotrophin-3 and BDNF are very good at creating new synapses. NT-3 injections were shown to work in animals, BDNF injections are being trialled by Otonomy (OTO-413, if I recall correctly, with a slow release formulation).

What's funny is that I used to work on slow release formulations/matrices in a research setting (it was polymer and DNA gels, activated by temperature or pH) and now I need one. Unlucky.

 

Will PIPE-505 cure both tinnitus and hearing loss?

 

No one on here knows.

 

From the pre-clinical trials PIPE-505 was stated to have grown synapses and minor OHC regrowth with little supporting cell loss.

 

Yea no one knows. Oversimplification of complex problem: some people have tinnitus but they have no hearing loss even extended audio gram post acoustic trauma. How can this be? One idea is well the hair cells are “ok” but the underlying synapses are damaged, and you can damage a lot of these before you have trouble hearing or it shows up in audiogram.

Long story short, heal synapses heal the underlying problem. Again no one knows but we’ll find out post trials… maybe.

 

Right. Exactly what I said. No one on here knows.

 

Investor update.

Frequency Therapeutics Provides Business Updates and Second Quarter 2021 Financial Results

“Based on the overall learnings from multiple completed studies, we plan to initiate a randomized and well-controlled Phase 2 trial in the fourth quarter of this year, using a single administration of FX-322 in a refined population of subjects with SNHL. In addition, this trial will incorporate several novel study design elements that we believe will help address previously observed study bias”

 

So what do we think here?

Just beating a dead horse because ain’t time to go back to the drawing board/lab?

Or could something good come from this?

 

Good find. It looks like we will have to wait until October or November for the results to be released. I am so tired of all the waiting. At least they plan on another trial before the year is over.

 

I just looked into my magic 8-ball, and it said "It is a sure thing".

It was right about me dating my high school sweetheart, too, so I'd say we are good. Just gotta wait.

 

I think this is positive. Everything pointed at single dosing giving limited but solid results and they kind of jumped the gun with their Phase 2. Better they prove a drug works half decently and gets released, as for the first time people have a possible repair.

I think they really thought that more doses would reach lower frequencies and they could put out a miracle drug. They are going to prove that the current formulation works good enough as a single dose or that it doesn't soon. That will determine how quickly they go back to the drawing board.

 

I must apologize Richie if I came across as abrupt. It was more a spontaneous reply. I got my tinnitus in 1992 so you can see that I had my abrupt answer off pat.

We gotta be gentler with one another -- and that's not easy.

Back in the 90's I heard that there's some academic paper out there titled: "The angry tinnitus patient". Well wouldn't you be impatient if you were waiting near on 30 years.

 

This means barely anyone will qualify to enter, and the stock talk will start again, as the rich get richer.

 

By "barely anyone will qualify to enter"... I think you mean, "patients that can show the drug is effective vs placebo will qualify to enter"...

 

Considering that this tends to address the two primary issues with the prior trial, it is incredibly reasonable and plausible to be doing what they are doing.

 

Totally true. The first change to this trial will be the fact that participants will get screened appropriately to start with and actually demonstrate that they are an appropriate candidate for the trial.

 

Are you talking about the severe hearing loss results or the repeat Phase 2 trial results next year October/November?

 

The statement just released said Q4 for the severe loss trial. On the ClinicalTrials.gov website, it says the trial ends in September. So, I am guessing October or November for the results. In terms of when they start the next trial, they said before the year is over.

 

So is this new trial just going to be larger with a single dose?

 

I don't know what you mean by larger? Looking at it, it won't be larger than the first single dosing trial in terms of numbers.