Frequency Therapeutics — Hearing Loss Regeneration

Probably, I think so...

 

It's nice to see that they are getting more money but it also seems that they are buying more time.

Not surprised...

 

They made it clear when they announced the San Antonio trial that it was a safety trial. The measures they use for safety are the same ones they use for efficacy, though, so...

 

It seems that as a group we oscillate between seeing Frequency Therapeutics as God's gift to the hearing impaired and seeing them as money-grubbers who are just stringing us along.

Maybe the truth lies somewhere in between?

 

“Our team is highly motivated to make a positive impact for the hundreds of millions of men and women worldwide who experience sensorineural hearing loss,” said David Lucchino."

"According to the World Health Organization (WHO), over 5% of the world's population suffers from disabling hearing loss. Five percent may seem like a small number, but that totals over360 million people across the globe."​

I think that covers everyone with hearing loss from mild to profound, or am I reading too much into that statement.

 

The first half of 2019... fuck, even more waiting.

 

Yes, first half of 2019 = this summer. And these results won't be thaaaat interesting. The ones we are all waiting for will be the ones which the current phase will allow if it's successful.

So we can come again on this thread in 2020

 

It is going to be God's gift to the hearing impaired. I wouldn't call them money grubbers. They didn't invent the process of approving drugs, they are just playing a game that unfortunately for us must be played. It would have been really nice if they would have included tinnitus as a metric in this trial and already released the results but oh well.

 

Rookie question, but would it not be possible to find and contact one or some of the participants, and simply ask them about tinnitus?

 

Possible, yes.

They have probably signed non-disclosure agreements with the trial agency though.

I forgot if @Deathtotinni mentioned anything about that. He made it all the way there so he may have some inside baseball on this topic.

 

Since they moved the results to the first half of 2019, is this effectively shifting the start of Phase II?

(I love you mods, btw.)

 

They can start Phase II before the Ib results get posted to the public.

Unless something negative happened in Ib.

 

They take far more metrics than just what they announce for the study.

 

While we all eagerly wait for the results, I'd thought I'd post this.



For those who don't know, Lucchino is the CEO of Frequency Therapeutics, screen captured from his Twitter.

I'd like to interpret his retweet as being positive news.

 

So if there are LGR5+ progenitors in the intestine, how are they getting activated without this fancy pants notch inhibitor?

 

We'll see.

 

It will.

 

So did we ever find anything out about the conference they had on January 7th? It seems like the financing that they announced came out just before the conference started.

 

I'd second that... surely the speech must have had some new information?

 

Good points. What I was trying to say is that the big news is that they got an external new investor who has seen all the data and after analysis decided to invest into Frequency Therapeutics.

In general, when looking at early stage medtech companies it is best to look at third party validation for the technology. When management says things are looking great and very promising, it is almost like noise as one has to be very suspicious because management and current owners have every incentive to make it look positive. We have seen it over and over again that technologies which according to management are very good have failed miserably.

So the important validations are new money from external investors, money spent by customers (not relevant here) and of course approvals by authorities. Taiwania Capital has gone through all the data and must see it convincing. Frequency Therapeutics must have a lot of efficacy like data but it is just that it is not yet in a format that can be approved by authorities and publicised but rather random efficacy information from the safety trials.

 

Frequency Therapeutics must maximise profits and value from the technology as they have already raised some 90MUSD from external professional investors. Owners of these investors look to get max profits back as is common sense.

Drug development is very very risky and failure ratios from phase 1 to approval are estimated to be around 90%. So 10% make it and when looking at hearing loss the success ratio to date is 0% which of course is not very convincing. And it is next to impossible to pick out the winners from easy stage drug development companies. So investors are forced to play a portfolio game where the one investment that makes it to approval must cover the losses of all the 90% failures.

This is very much simplified math but in a portfolio of 10 investments each 100MUSD the one that gets approval has to cover the losses for the 9 failures or 900MUSD before they are at break even and not losing money. One can of course start to look at details and assume that not all losses are 100% and they may recover something from those not making it to approval but this pretty much the big picture.

 

I didn’t screen with anyone else. I think they only screened one person a day. I thought about waiting outside in the bushes for the next person to come along but didn’t.

 

Does anyone have any idea when the next study will be or how to find out when it is starting?

 

I second this. Are we really going to have to wait until the summer before they release the results of the trial? I mean, come on! The trial ended in December. Why won't they release the results?

 

Although the trials finished in 12-2018 they still haven't published so we need to wait for them first and see what happened to those 24 people. By the way, if they will be successful there were exclusions in the trials:

Exclusion Criteria:

1. Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in either ear. This includes a current tympanostomy tubes.
2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
4. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
5. Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
6. History of clinically significant vestibular symptoms at the discretion of the investigator.
7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
8. History of head or neck radiation treatment or exposure.
9. History of substance abuse within 2 years of the Screening Visit.
10. Positive urine pregnancy test or breast-feeding.
11. Any known factor, condition or disease that, in the view of the investigator, might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease or suicidal tendencies.

So if you look at the data for the time being there won't be any luck for people listed at least in 1-2-3-4. Unfortunately. Of course it may change but we're talking about years.

 

Yea it is completely asinine to think that after this second trial that they wouldn't be looking at the audiograms that they are definitely giving the subjects to see if their hearing improves. As of they wouldn't be interested because "this is just a safety study".

 

People that are saying that they have no knowledge of efficacy at this point "because this is just a safety trial" need to sit this discussion out because they are clueless.

 

The investigators literally said they are testing to see if there is improvement in hearing.

This is an efficacy study disguised as a safety study. They are mainly testing for efficacy from what I gathered. They are giving you the drug, keeping you overnight, testing hearing, bringing you back to test hearing, and then back again to test it again.

These people who are saying they aren’t testing for efficacy need to leave the thread till they educate themselves about the study.

 

Reading through that exclusion criteria made me think to ask the question, which I think has already been mentioned, but are we thinking this will help with vestibular ear issues?

 

I have not read the protocol, but they may be using a hearing test as a safety measure in the sense they want to look for an adverse effect of the drug on hearing, ie. has hearing worsened as a result of drug use. How do the timepoints compare to the time it takes for hair cells to regenerate? TC