Frequency Therapeutics — Hearing Loss Regeneration

If it's any consolation I experienced this and also distortion at certain frequencies (so some noises sounded more unpleasant than others and shrill and nasty) but it's calmed down a lot over the past few months.

 

It became more noticeable in the last month. If I go to sleep I wake up with a drilling sound. Increase stress and the shakes. What do you do to deal with it?

 

https://seekingalpha.com/article/43...-data-from-exploratory-study-proves-promising

More info about the conference, not just about the past top line data. This is the make or break point for the company!

 

If you read the comments the author is not worried about the recent selling of some stock by insiders. He has a very positive outlook for this company. Also interesting to note the May report of Frequency mentions Astellas paying them in case of any Phase IIb or Phase III trials in Europe and Asia. I think there’s a chance they’ll do American and European trials starting from Phase IIb to speed up eventual applications for approval in the biggest markets (US and EU).

 

Just called FX-322 trial center in Nebraska.

They are accepting patients. They have lifted travel ban for patients traveling out of state due to COVID-19.

I asked her if they will delay results. She said they are only a testing site. Frequency is the only one who knows this. I said these are exciting times and she said “yes”. Told her I might hold off applying for this phase till we get more data.

 

What kind of "yes"?

 

She said yes? You qualified for the trial? What does your hearing test look like, may I ask?

 

I wonder if you had given her your hearing test results whether you would have been accepted in the trials or not.

 

What was the tone of her voice when she said "yes"? I can't imagine many responses to the question "these are exciting times" other than some kind of positive response. But how someone says it can say a lot. Though then again, I may be reading too much into this.

 

Mask it with YouTube videos and phone apps with phone under pillow at night playing rain. I function normally with masking.

 

Unfortunately, masking reactive tinnitus makes it worse for a lot of people (myself included). Any consistent external noise causes my tinnitus to react. I’m best in quiet rooms, but I try to have some exposure to reasonable sound levels to avoid further sound sensitivity. Some believe this condition is a subset of hyperacusis. Regardless, reactive tinnitus is no fun.

 

Her tone of voice was very hopeful. Also told her a lot of people are looking at this trial and hoping for the best.

 

25 dB loss at 3 kHz and 4 kHz, also high frequency loss of 30 dB at 16 kHz.

 

I tried to enroll in this phase of the study almost a year ago or so — way before the COVID-19 mess. They asked me to send my audiograms (had SSNHL in right ear with ski slope and stable audiogram over the past 5 years).

It took them forever to get back to me and when they did, they said I didn’t qualify. I asked why but she wouldn’t say and said I should re-apply when phase 3 starts.

My word score is 85% in my right ear and think — my opinion here — that this may be too good for this phase of the study because (I think) they are ‘fishing’ for a good p-value: the previous phase showed improved word score with those who had really bad word recognition to start with and they want to make sure the same thing happens with the 3 experimental doses. At that time — again before COVID-19 — she thought phase 3 would begin around September 2020 and told me to call them back then (saved the phone number).

So I bought a lot of FREQ at the IPO figuring that the stock would soar when they announced the positive results — that they are more than likely trying to get by only enrolling people that benefited from the last phase. If one dose got that result then 3 ought to too.

 

I really hope the other clinical trial locations have opened back up again. I really don’t want there to be a delay in the results coming out.

 

Fully agree with you. It only makes sense that they are likely looking for a word score sweet spot. They are trying to get it fast track approved specifically for "clarity" so they need to find people who have this problem to begin with.

Interesting that she said phase 3 and not phase 2b though.

 

I think that FREQ thinks that with a phase 2a study they’ll b able to move straight into phase 3. That’s why they’re being so picky with enrollment now. I remember her saying that (if that’s the case,) they’ll need a lot of subjects for phase 3 (and thus implying they’ll not be as picky).

 

I really hope it’s Phase 3 next. I want this drug to come out ASAP.

 

I really hope that’s the case. They are probably trying to be picky for Phase 2a since patients will receive 3 additional doses rather than 1 dose only for Phase 1b.

It’s about time us sufferers get cured.

 

I don’t think they will move to Phase 3. They themselves call this Phase IIa and they even state they will receive money if Astellas initiates a Phase 2b in Europa or Asia.

Also, let’s consider the rationale behind Phase 2. Phase 2 is intended to establish dosing and patient population. Then you would need a Phase 3 to confirm efficacy in that dosage and that patient population in a larger group of people. Right now, Frequency is testing up to 4 injections on patients with up to 70 dB hearing loss. However, Phase 1/2 indicates the drug is most effective for moderate-severe patients with bad word scores. Therefore, it makes sense to test the drug on patients with severe hearing loss (90 dB) in Phase IIb. Maybe they’ll tweak the patient population in other area’s as well. Perhaps they’ll even do 6 injections, who knows. Phase 2 is important because the larger the potential group of patients, the more extensive any approval from FDA/EMA would be. Then, once they know what works best and for whom, they’ll do a Phase 3 to confirm and Phase 4 after release of the drug.

 

If they're still accepting enrolments now, that blows the September 2020 completion date out of the water. They make their final observations 210 days after a subject starts. That's 7 months after the final subject gets their first dose. It took them about 5 months (from memory) after 1b to say anything about the results.

So, about a year after the last subject gets their first dose, and they're still recruiting...

 

They stated that with COVID-19 they could still have fewer participants than their estimated enrolment. So it’s still possible the delay might not be that much.

 

It makes sense what you are saying, but I hope you are wrong.

 

Me too.

 

I don’t know about you all, but I’d gladly accept a few months of delay in the short-term if it means Breakthrough Status is more likely from Phase 2a/2b results.

Also, Frequency did mention releasing some “top-line” data from the study. This may be delayed as well; but considering how active the company is in communicating, they may still make an update on the Phase 2a, even if it is ongoing.

Finally, let’s not forget that they started dosing participants in the P2a in October of 2019. So by now, some patients have likely completed the trial. So, Frequency has some data.

 

I don’t mind if there is a little delay if it allows them to get Breakthrough Therapy status and be able to go to Phase 3 next.

 

They're presenting at a conference tomorrow (virtually) so we may get some updates then.

 

A good portion of it cut out for me. Anyone able to watch this in its entirety?

Nothing new except he said "most of it is concentrated in the highest frequencies" but it seemed implied to me at least some of the drug made it lower.

Addressed COVID-19 briefly and said there were delays and they were doing the best they could but offered no updated timeline expectations.

 

Just listened to the Jefferies presentation. To quote CEO, David Lucchino regarding the hearing program (FX-322):

"Our goal is to treat the full spectrum of sound."

So, let's all agree to end the ongoing anxiety surrounding Frequency stopping development at only the high frequencies.

 

Is there a link to the presentation?