Frequency Therapeutics — Hearing Loss Regeneration

Yes, they will wait. The strategy is almost outlined in their presentation. They compare the three trials to the patient populations affected.

By waiting for all three trials to end, they have data to confirm FX-322 is safe for mild-severe SNHL, NIHL, age-related SNHL.

This is a huge population for recruiting and allows them to designate the drug with the FDA in a single pivotal trial.

I would expect if they all look promising, Breakthrough Therapy status will happen in Q4/2021. Pivotal kicks off 2022.

They will certainly do an interim analysis of the Phase 3.

 

My guess is for several reasons:

a) So they have less exclusion criteria for FX-322 and can recruit more quickly
b) So that they don't have to run separate Phase 3 trials for each related group (age-related/SNHL/severe)
c) So that they can maximise their market potential as soon as possible

 

Age related hearing loss becomes observable on the audiogram at 40 years old. They’re recruiting older cases, but the diagnosis is still the same.

If you read their investor deck, the cause is the same, hair cell loss.

 

If they have to wait for all 3 trials to be done before they start the pivotal phase, this is going to take forever.

I do hope if 2/3 trials are completed, they could start the pivotal phase while waiting for the 3rd clinical trial to be completed if the results look good.

I do hope if they get Breakthrough Therapy status that this could speed everything up and maybe 2022 will be our year.

 

Perhaps people here are interpreting this as "the year 2023 is when FX-322 will reach pivotal trials" when the actual meaning of it is "Frequency Therapeutics has the capital to sustain itself well into 2023 regarding pivotal trials for all of its products, including Multiple Sclerosis and other regenerative therapies."

My very optimistic opinion.

 

So depending on how things go, it could be possible for FX-322 to come out in 2022 but 2023 is more conservative.

 

First hand experience here - after a loud event my tinnitus became a lot worse followed by an increase in hyperacusis. I think when some hearing input is lost, the brain compensates by making the remaining cells more sensitive to sound AND seeking other pathways to obtain the lost input. It's a feedback loop. Almost anything other than normal talking will now cause my ears to completely "clip" or "redline" with pain -I can't explain it. Sensitivity has shot through the roof.

I think by restoring some hair cells, the brain will interpret that as more auditory information and end up perhaps quieting down both hyperacusis and tinnitus - at least that's my hope. More auditory input might also have the opposite effect by enchancing existing neural pathways which might be wired incorrectly. Nobody knows for sure. It's like the feedback loop of an amplifier but a billion times more complicated and different for each individual.

 

Quoting a Wall Street Journal article:

“Fast track drugs often go to market after phase 2”

I believe Frequency Therapeutics added the two additional studies to substantiate this. This is a huge unmet critical need.

 

Thanks Danad for posting this. I really needed this. If true that after Phase 2 they can release FX-322, it will be a miracle. Surely with the COVID-19 vaccine, the FDA will show some leniency by allowing FX-322 to skip clinical trials or reduce the time to release it out in the market. Maybe 2022 will be our year.

 

I agree with your theory as well. I think when we lose hearing input, somehow the brain compensates it by increasing the gain at lower frequencies and making things sound louder and more painful at lower decibels.

 

Do we have any numbers to elucidate what they mean by "often"? My understanding is that only 25-30% of drugs that make it to Phase 2 go on to Phase 3 (not fast-tracked ones), so I'd be interested to know what the difference is.

Edit: I think I found said article but it seems to be behind a paywall. Anyone willing to do God's work?

 

What's your source on this?

 

Is anyone here planning on listen in to the JP Morgan Healthcare Conference webinar tomorrow morning?

I am not able to attend for the Q&A portion, but would like to know what was discussed.

 

I thought the same thing when this happened! I mean what is the point of Fast Track if you just make them go through all the same phases as a drug that isn't fast tracked.

 

What's the time and the time zone? And do you have a link? Thanks!

 

https://investors.frequencytx.com/events/event-details/39th-annual-jp-morgan-healthcare-conference

First 30 minutes is presentation. Second is a Q&A.

 

See this article:

Fast-Track Drug Approval, Designed for Emergencies, Is Now Routine

I used to have a subscription, and it talks about how many drugs go to market after Phase 2. It's a good paper but it's just too expensive (I signed up on a whim during one of their sales, but then cancelled later when the price reverted to $40 a month).

 

Good news is FX-322 already has Fast Track status as of Q3/2019.

 

Now we are waiting for Breakthrough Therapy status.

 

So anyone can sign up? Or do I need to have some investor interest, etc?

 

Anyone can sign up.

 

Here is a screenshot I took from the WSJ article a while back:

 

Thanks Danad. If they do release FX-322 after Phase 2a is done, would 2022 be possible?

 

Hello everyone. I have been lurking on this forum (and following the development of FX-322) for a year now. I hope posting in this thread first thing is not bad etiquette! I will be watching the presentation and am optimistic about the drug.

I just read, however, that the CEO sold 10% of his stocks very recently. I am far from an expert on such things... Is this worth being concerned about, given the next trial results will be out fairly soon? My intuition tells me it isn't a good sign (considering its timing), but again, I know very little about stocks and insider selling etc...

https://www.marketbeat.com/stocks/NASDAQ/FREQ/insider-trades/

Please forgive me if this is a spanner in the discussion!

 

If large stock sells could be used to predict the success or failure of a biotech then anyone could be rich investing in this sector. It absolutely does not work that way.

C-suite employees are often paid in stock (or mostly in stock) and then sell pretty regularly.

 

Non-Issue. Rule 10B5-1 Plan.

 

A bit off-topic, but I want to welcome you to the forum! I appreciate your kind and clear writing style.

As long as you are talking in general about FX-322 or the associated science, you should be fine to share your thoughts or questions here.

 

Thank you very much for the warm welcome! And thanks to the posters who answered my question above.

I will endeavour to stick to issues around the drug or the associated science should I ask/discuss more here.

All the best!

 

I feel like many people here are getting overly excited. I hope FX-322 works but don't put all your eggs in one basket. I hope it works as well but the FDA will drag this out I'm sure. Reason being is they don't care.

 

Wouldn't FDA giving FX-322 Fast Track status prove otherwise?