Frequency Therapeutics — FX-345

You're right. It is... so could be any time.

 

Sorry to ask, does this mean that their trials have been successful? Could any of these be coming out in 3 years?

 

They haven't even started any trials for FX-345 yet. FX-322 will have results for Phase 2 early next year. If the results are amazing, then they will launch it ASAP. If results are good, then they do a Phase 3 and it will be 2 or 3 years till it gets to market from there. If it fails, then that's probably the end of the entire company.

 

Are they able to bypass Phase 3 completely if they have Breakthrough/Fast Track designation, provided great results next year? I can't find anything really for that through searching internet results. Then FDA NDA applications take around a year for review; quicker with accelerated approval.

Hoping they see tinnitus as a life threatening/serious disease and grant the accelerated status since it is a secondary outcome. Even the primary measurement, word recognition, could be construed as life threatening and serious in certain situations. Like in the military for example, the soldiers would have a better understanding of instructions by the Sergeant, which in itself is life/death, like enemy coordinates.

 

It has Fast Track no matter what, but it can skip Phase 3 if results are exceptional. I am not going to get too excited about it because there's definitely a chance it could fail too.

 

The tradition used to be that you needed 2 pivotal trials in order to apply for FDA approval but, over the last 15 years or so, approximately 53% of new drugs today get approved by the FDA with only 1 pivotal trial. FX-322-208 is going to be considered a pivotal trial so there is a small chance the FDA could tell them that they can apply for NDA upon a successful readout. They already have Fast Track status which cuts FDA review time down from 1 year to 6 months.

 

I guess no news for October. I didn't think they generally started trials during the holiday season, so I'm not sure what to expect for November and December.

 

Biotechs operate year round. If they didn't run trials during holiday season, then they would just be sitting and waiting while burning cash daily.

 

Johns Hopkins is running a trial during the holiday season for PTSD. They run trials during the holidays.

 

Wow. I came back to this website because hearing in my left ear has become worse. To think that Frequency Therapeutics might actually get on the market within the next few years is profoundly encouraging.

We may actually be close to the new era where hearing loss can be treated. If Hough Ear Institute eventually works out, then that would be great too, because another aspect of cochlear damage would be treatable.

 

Man if these drugs turn out to be a bust. It looks like they are going to wait until they release the results of the FX-322 trial before they start the FX-345 one.

 

Frequency Therapeutics Announces First Patient Dosed in Phase 1b Study of FX-345, the Company’s Second Therapeutic Candidate for Sensorineural Hearing Loss

Exciting!

 

I went on ClinicalTrials.gov and couldn't find it. I wonder when they plan on rolling out trials.

 

The news just keeps getting better and better. Hopefully it makes it all the way through.

 

Very exciting indeed!

I thought they were going to wait until they had the results for the FX-322 trial but maybe the results have been good for that. I can't see how they would be starting this without knowing the base drug had good results.

 

Supposedly, what's the difference between natural hair cells vs. the new ones? Are they more vulnerable? Not as clear?

I'll take what I can get, but I'd love to know if they are about equal.

 

As long as they still release FX-322 out in the market first (with FX-345 still in clinical trials), it will be good. I hope they don’t hold back FX-322 where it could help the majority of us here and have to wait for FX-345 to come out.

 

There's no chance of that happening in my mind. They want FX-322 on the market ASAP.

The results of the latest trial will be out in about 3 months. I'd be surprised if the results weren't good.

 

They need cash flow. They are not going to wait.

 

I hope that’s the case. I was surprised when they announced the 1st dosing of FX-345 when the results of the Phase 2b FX-322 hadn’t come out yet.

Originally they were going to start the FX-345 trial in October but, with the delayed results of Phase 2b FX-322, I guess they must have decided to go ahead with it once they found out the results were positive with the current FX-322 trial. I hope their reason for starting the FX-345 trial is not because the results were negative in the current FX-322 trial.

 

FX-322 and FX-345 are different drugs, I'm not sure why you think they would wait for results of the former.

 

They are different but very similar. If FX-322 doesn't work, then there's little chance that FX-345 will. Regardless of that point, if FX-322 doesn't work, then they probably won't have enough funding to go ahead with FX-345.

It does seem like they're going ahead with this trial because the latest FX-322 results are good but that's a lot of assumptions.

It's good news anyway regardless.

If FX-322 goes to market quickly, I wonder would that somehow also speed up FX-345's time to market?

 

The results of FX-345 are not contingent on the results of FX-322. The company always intended to conduct the FX-345 trial regardless of the results of FX-322.

Not working and failing to reach statistical significance are 2 different things. If FX-322 doesn't work, it means the compound has no effect on cochlear hair cells. If it fails to cause stat sig improvements, it means that it may still be working but it isn't penetrating deep enough into the cochlea to show stat sig improvements and that's where FX-345's deeper cochlear penetration could make a difference. The company has enough money to see the FX-345 trial results regardless of the FX-322 trial results.

 

God, the anticipation is killing me. I wonder when they start trials. January? February? March?

 

When I say not work, I mean failing the trials.

 

In that case, then I will have to disagree with the statement you made saying "If FX-322 doesn't work, then there's little chance that FX-345 will." The whole point of FX-345 is to potentially produce more efficacious response in more patients compared to FX-322.

 

Yeah, I disagree with my original statement too. Probably just less chance of FX-345 passing the clinical trial if FX-322 fails in the clinical trial, but not impossible for FX-345 to pass if FX-322 fails.

 

First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss

 

Inclusion Criteria - I'm confused.

• At the Screening, Lead-in (Visit 2) and Treatment (Day 1) Visits, a pure tone average of 40- 80 dBHL at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the potential study ear to be injected

Reason for this? I didn't think they were looking that deep. Doesn't FX-322 target above 8000 Hz and, well, what happens from 4000 Hz-8000 Hz?

I also noticed they are not looking at efficacy at all, even as a 2nd outcome.