Frequency Therapeutics — Hearing Loss Regeneration

Good point! To add to this I just read a paper that showed near complete loss of OHC and 2/3 loss of IHC in a cat following extreme noise induced cochlear damage, and after they ran the histology reports a year later they found that the majority of support cells still remained intact.

I’d link it but this was a few days ago and I lost track of it on my phone unfortunately. I haven’t been on this thread for a while now so forgive me if you have already read or mentioned it.

 

I don't think any info on this has been made public.

 

To return to my musings about the NHS and adoption of future NIHL drug treatments, I came across this article from last month. According to it, around 355,000 people are fitted with hearing aids per year in the UK, at a cost of £450 million to the NHS. 1 in 6 people suffer from it so it's extremely common but according to this only 30% of people given hearing aids actually use them as often as recommended and a further 20% don't use them at all.

I honestly think FX-322 will be far more cost-effective than hearing aids and I think will lead to a much higher uptake in treatment. Hearing aids have so many drawbacks and lots of people are clearly put off using them. I think it would be a no-brainer for governments to make it available.

Research could lead to step-change in NHS hearing aid provision

 

There is a thing that tends to have good outcomes called cochlear pumping and recent research suggests that the technique can get medicine deep into the cochlear.

Consequently, I can see Frequency Therapeutics investigating something like this at some point in the future if their current technique is ineffective or not demonstrating that it shows benefit with multiple injections. It is likely that there will be further work done into cochlear delivery not just from Frequency Therapeutics but by also others in the near future.

 

If that’s the case that FX-322 will most likely be cheaper than hearing aids then I reckon the NHS will fully cover it just like they cover hearing aids.

 

There's probably a lot more to these calculations and costs than my naive assumption, but that is an estimate of £1267.61 per person.

Assuming it is easier to mass produce and assign drugs like FX-322 than hearing aids, which I believe is a fine assumption to make, and further assuming Frequency Therapeutics wanting to negotiate a situation that makes them, their shareholders, the government agencies, and the patients happy, would that not imply FX-322 costing the government per person much less than that figure?

If so, that's a bright situation to anticipate. Any government having the opportunity to spend less money would be happy with that deal.

All you'd have to worry about is whether or not the government takes the gift right in front of their eyes. Without trying to get too political here, when you said:

Governments anywhere don't always act the smartest.

 

Governments negotiating for pharmaceutical pricing deals is not new and has been going on for sometime. Stuff like this has happened with the SARS-CoV-2 vaccines and deals being struck to obtain these both from a price and supply perspective. The same has happened in Australia over many years with more mainstream medicine like heart medicine but also with more specialist medicine like treatment for Cystic Fibrosis that would have cost the takers $1000s if this was needing to be sourced on their own. Obviously the benefit is also there for the pharmaceutical company due to their ability to mass produce and also gain more sales than they would have otherwise if the deal hadn't been reached.

These government deals are actually very similar to the situation around why we might not be able to obtain FX-322 through compassionate access/use.

> Compassionate Use = Disincentive for customers and Frequency Therapeutics due to high costs of production for a small run of FX-322 and therefore will lead to high consumer pricing.

> Supply Agreements with Governments = Incentive for customers and Frequency Therapeutics due to lower costs of production (mass production due to agreed supply amounts) and cheaper consumer costs due to the price of FX-322 being made lower through the lower production cost and guaranteed sales.

 

Does anyone know if the results are coming out at the beginning of March or the end?

The waiting is gut wrenching.

 

They said at the end of March but may end up releasing Day 90 results early April.

 

“Late Q1 2021” is all that has been known since November.

 

In the coming week, Frequency Therapeutics will be presenting at the 39th Annual JP Morgan Healthcare Conference - on 13 January at 7:30am ET with a presentation by David Lucchino.

There will also be question and answer session after the presentation at 8am.

There will be live webcast and a replay available afterwards.

Frequency Therapeutics to Present 2021 Business and Pipeline Overview at the 39th Annual J.P. Morgan Healthcare Conference

 

This news might probably have given Frequency Therapeutics' stocks a boost. It just went from 33 dollars to 39 dollars. Some peeps probably think that the company will prop up some good news on this conference.

 

I only have mild hearing loss. Knowing a drug exists that would regrow the hair cells inside my cochlea and could restore full hearing, yet can't have access to, is infuriating.

I would do practically anything to get my hands on FX-322.

 

A clever manipulative move from insiders, seems like they sell every week to entice speculative buyers leading up to the 90-day. Great for swing traders and those with sensorineural hearing loss - no need to FREQ out, it's good news!

 

It is irritating, however the FDA process is necessary and also a good system to ensure what comes out is beneficial and safe. I don't like possibly having to wait, however it is necessary.

 

Anyone know if people that were born with hearing loss and then additionally lost some hearing over the years will benefit from FX-322 or nah?

 

David Lucchino talks a bit here about Frequency Therapeutics - it's pretty brief but his overall tone seems pretty optimistic. Interesting that since the pandemic started, their headcount has increased by 55% and he mentions that they are entering "an important period in the evolution of our company."

https://www.pharmavoice.com/article/2021-01-biopharma-ceos/

 

Does anyone have some advice for getting the maximum benefit from FX-322?

 

Probably depends on what's causing the additional hearing loss. If it's standard hair cell loss and there aren't confounding genetic issues (e.g., Otoferlin abnormalities), I think so.

Also, companies like Akouos are working on restoring the correct genes for some of those sorts of diseases too.

So it really depends.

 

I'm not sure how much of this is just positive corporate speak, but it was pleasant to read all the same.

The fact that they've gone full steam ahead despite the restrictions of the pandemic shows their dedication and adaptability. I wonder, should the restrictions of the pandemic recede given distribution of the vaccine, how much better they can perform.

 

Take care of your ears as best as possible before it comes out (and even after).

Especially with noise, synapse damage can often happen before hair cell loss.

 

It's likely that an end to the pandemic would mean:

- Faster recruiting for the remaining phases, so the phase takes less time to complete
- Potentially faster response from the FDA (since they aren't spreading resources to COVID-19)
- Potentially faster ramp-up of production of FX-322 by the US Contract MFG / Astellas
- Easier dissemination of information to ENTs, Audiologists, Patients (since COVID-19 won't be a communication limiting issue)

 

I don't think that this can easily be answered. At this stage I don't know whether even Frequency Therapeutics knows how to give candidates the best outcomes from FX-322. Hence how they have said that they might look at things like reformulation and redosing after the completion of the clinical trials.

FX-322 is showing benefit and hopefully enough benefit to gain approval but some of the factors like how deep FX-322 can get into the ear won't be known until they actually get evidence on it.

 

It probably would lead to faster distribution in countries which require their own regulator to approve medicine. Therefore eliminating the need to potentially travel for some people.

 

Hi everyone, I am just wondering if there is going to be a Phase 3 trial since there is no other medication they can compare FX-322 to?

 

That's a good question. If there is a Phase 3, it won't take as long because there really isn't a question anymore of "if it works".

 

There will be if they can show positive results in their current Phase 2a clinical trial. It will be easier to prove that FX-322 works as improved hearing is not a placebo.

 

If the hair cells regenerated by FX-322 aren't straight, does it affect hearing or is it just aesthetics?

 

We don’t know. Maybe we need additional FX-322 shots to make the hair cells like the ones that we had before loud noise exposure.

 

Are there any experiences or concepts of FX-322 or OTO-413 passing or bypassing a surgically sealed round window membrane (connective tissue added during tympanotomy) to enter the cochlea in a somehow promising concentration?

Anyway, would love to experiment one day to find out.