Frequency Therapeutics — FX-345

Oh man. I got really excited seeing South Carolina on there, only to see that they're only accepting people with worse hearing than I have. Disappointing, but understandable.

I hope that this doesn't mean I wouldn't be able to have it when it hits the market. I would really like this tinnitus and hearing loss notch of mine fixed.

 

I would guess that doctors will be much more lenient prescribing it if it does hit the market as opposed to criteria to enter clinical trials.

 

I hope they add more sites because none of them are near me. Otherwise, this is very exciting.

 

I hope so. I would understand if there was caution, however, until they did a safety test for people with slight to mild hearing loss.

 

It’s a safety trial. Not an efficacy trial.

 

@Gb3, yep, I was aware. It's just that they often have secondary outcome points that don't affect the trial progression, but measure other outcomes they may look at in later trials.

 

These clinical trials are the safety tests.

 

Yes, but there could be considered risks for people with slight hearing loss. After all, they're putting an experimental serum into the round window of the cochlea. Perhaps there are concerns it could make hearing loss worse for people that have hearing good enough for it not to be worth it.

 

It says they're enrolling only 36 people for the trial. Damn that's low!

 

Totally normal for Phase 1 trials: https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

 

Nope. Not low for a safety trial.

 

I believe it's low on purpose since it's just a safety trial, so in case the drug ends up being extremely dangerous, they don't want to harm a large number of people.

 

So they probably won't be adding more sites then?

 

I have no idea to be honest. Phase 1 trials are always small as previously stated. If it's successful, then the Phase 2 trial will be larger.

FX-322 will be recruiting for Phase 3 sooner than FX-345 Phase 2 if all goes well. Phase 3 recruits the largest amount of patients.

 

So, we're gonna have to wait a year just to see if there are any side effects from FX-345, but they won't be measuring effectiveness?

 

Which of the two, FX-322 or FX-345, will help us the most though?

 

Tinnitus (TFI) is on the secondary outcome measures list for the FX-322 read-out due in Q1. If we see any benefit reported at that time, I think it's reasonable to assume that FX-345 should be even better.

If there's no benefit seen with FX-322, then we just have to wait and see if the deeper penetration of FX-345 can make a difference.

It'll be interesting to see for sure, given the whole debate of whether tinnitus is 'is the ear' or 'in the brain', or progresses from one to the other, or is different for different people, etc.

Of course, the ideal scenario is between Frequency Therapeutics for damaged hearing, and XENON Pharmaceuticals, Biohaven and Dr. Susan Shore for the DCN in the brain, where we might end up with a robust improvement within the next few years through a combination of solutions - hopefully not too much wishful thinking on my part!

 

It's obviously entirely personal but I think if your tinnitus is high-pitched, then FX-322 could be beneficial since it targets the high frequency parts of the cochlea. And if you have lower frequency tinnitus, then FX-345 may be better for you.

That could be completely wrong but it's how I see it.

 

Tinnitus is in the DCN, given recent research/findings.

 

No disagreement with the research and clinical trials that support this (Shore, Tzounopoulos, Trobalt, etc), but the reason we're all also following developments in hearing restoration is because of the evidence that shows some (not all) people get tinnitus relief from cochlear implants, and other experimental treatments involving stimulation of the cochlea. Time will tell of course, but for the moment, all research into either hearing restoration or direct action on tinnitus is a good thing and hopefully we get something positive out of it soon.

 

Tinnitus is a symptom. It may manifest in the DCN, but that doesn’t mean treating hearing loss couldn’t stop it. Also, people who had deep brain stimulation for Parkinson’s, have had their tinnitus go away. This means there could be multiple pathways to stop it.

 

@ploughna, oh I agree, it's only one angle, but you would think increasing auditory input will cause changes in the DCN.

@Gb3, yep, lots of ways to return signalling back to a healthy state.

I don't know what you think but it looks like 2 main avenues:

1) Increase auditory nerve input
2) Depress DCN activity

Many ways to look at doing that but limited treatments on the market.

 

Welcome to the world of clinical trials!

 

I believe it's about 9 patients or so they are truly only testing for safety on first. Once it appears safe in the first subset of patients, they will continue the trial and dose the remaining patients and then they will also be testing for hearing outcomes such as audiograms and WR tests but the success of the trial is not contingent on said hearing outcomes.

 

Regenerative Medicine and Hearing Restoration:...

This short directly discusses FX-322 and there is some mention of FX-345 for those who are interested.

 

So, they are testing the hearing in some of the patients?

 

Yes.

 

I wonder why their stock has jumped up so much in the last the 3 trading sessions. Speculation of upcoming positive news possibly? Up almost two dollars in the last week and a half...

 

My feeling is some of it has to do with the media attention the company has been getting lately (CBS segment, etc...).

 

Like someone else said, it's probably the hype starting again. Although for once I hope it's insider trading