Frequency Therapeutics — Hearing Loss Regeneration

Regain will finish Phase 2 in December this year and have results next year end of April.

Hopefully Regain will go to Phase 3 next.

 

I have no clue why Frequency Therapeutics had to wait until now to start Phase 2a. They could have recruited people earlier.

 

Count on a second phase 2 trial first with more severe types of hearing loss. Right now the cut off for them is moderate hearing loss. Won’t surprise me if they go to ‘severe’ in phase IIb. They even said on the Action on Hearing Loss UK website that they are looking at that.

I can’t stress this enough: these are hearing loss drugs, not tinnitus or balance drugs. It’s not gonna be like “Aha, this cures tinnitus/balance issues per our Phase 0! Screw hearing loss, let’s get this on the market now!!”

 

Yea maybe. Hopefully they can go straight to phase 3.

 

If they are going to expand the patient population, they probably want to go through a Phase IIb trial first. I doubt they will go to the EMA for approval for severe hearing loss patients with just one Phase III trial. Another possibility is to do two Phase III trials, which takes even longer.

 

Because we are simply not that lucky.

 

Recruiting a center, recruiting doctors/researchers not involved in the company, working on the trial design, getting it approved by the FDA, screening patients, getting money to finance it... Frequency has no incentive to act slower than necessary.

 

My beef is not so much with trial design, but a lack of expanded access during clinical development and unnecessary time between trials. Take the Hough pill for example. These guys are sitting on a 5-year old safety study that a pill they have in a drawer somewhere in Oklahoma is “extremely safe”, uses two compounds one of which you can get in a drug store, gets you a little bit of hearing back, and quiets your tinnitus. Why can’t I buy it while they are investigating it in further trials?

 

That is a good question. There is still a share price stabilisation mechanism (overallotment) ongoing following the IPO so current price probably does not yet fully reflect freely traded price. As the share price is at the lower end or below IPO price range it is likely that underwriters have bought back some shares to stabilize the price.

“Frequency Therapeutics (FREQ) will offer 6.7M common shares at $14 – 16 in its IPO. Underwriters over-allotment will be an additional ~1.0M shares.”

It is not an easy share to value as they don’t have the typical P&L items for valuation but instead share price will be newsflow driven for quite a long time. It is important that now following the IPO and previous financing rounds they have very solid funding base that should allow for advancing the development as planned and hopefully speed it up further.

 

Sir, I've been going absolutely mad over the lack of access to these potential treatments and the time it takes to check all the boxes. It's all about money and markets. Don't listen to idiots that keep saying this is all about safety and protecting us from snake oil. I get that, the time it takes to perform these trials is artificially inflated.

 

Dream on... for example CFG166 is in phase 2c after more than five years... courtesy FDA.

 

Especially with Hough, this seems like an FDA overreach. They should be able to use this drug on patients at Hough since it is deemed safe and developed there. If they needed the FDA to sell it to a wider market, I get that but the drug was developed at Hough and Hough sees otologic patients clinically.

 

Seriously. Wow that’s a long time. Well they can’t wait too long or a competitor will release it first and they will lose big bucks.

 

Yep. Audion is now a half year ahead.

 

That’s if they go straight to Phase 3 and I hope Phase 3 is similar to Phase 2 period then hopefully they can release to the market

 

I've been saying this ad nauseam, but the FDA serves in part as an artificial barrier of entry to protect the markets from disruption. It's not a conspiracy theory, it is obvious. They aren't there just to make sure the drugs are safe (because they aren't) and effective (which many of them actually are, because they have to be to make money).

If the Hough Ear pill worked well and was safe and was released tomorrow, what kind of hit would the hearing aid industry take? How many of their lobbyists would be flying straight to DC to spread disinformation about the pill? It would happen just like that.

 

They might increase recruitment centers along the way, it's happened before.

 

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The hearing aid industry would definitely take a big hit if this drug were to come out and cure our suffering.

I wonder what they would profit off instead. Custom made earplugs.

 

I think CGF166 is still in phase 1/2, but they are doing it in tranches so to speak, hence the ‘c’. I think the reason that drug is in particular long development is because of previous gene therapy trials were people got hurt/died (I have to look it up). I think that’s also the reason the FDA won’t lower the entry to moderate or mild hearing loss. Too much risk. It doesn’t have anything to do with the drug being more tailored to profound hearing loss cases. In fact, it will probably be less effective for that category since they generally have the fewest supporting cells.

 

Well, hearing regeneration drugs have one advantage in terms of durations of trials: either they regenerate hair cells or nerve endings or they don’t. You’ll probably know how well a patient will do on the drug six months after the last treatment, maybe even sooner. Compare that to for example a drug that halts Parkinson’s or MS or something, where you have to follow patients a few years to make sure the drug stops the progress of the disease in the long term as well. And patients generally have to keep taking those kinds of drugs, so that would be another reason to follow them a few years.

 

Ouch. And that is just a 2a... Maybe it's time to go down the rabbit hole and try to find something natural that can help restore hair cells and synapses... At this rate, even if successful, we are looking, at best, 5-7 years until this gets released. And if these treatments in trials fail, then forget about it, we would be looking at a decade+ worth of waiting.

That seems like an impossible waiting game.

 

The hearing aid industry is here to stay... we’re talking at lest 20 more years if not forever. Hopefully they will get better too. In my humble opinion.

 

I just checked ClinicalTrials.gov and it says completion date 30th September 2020.

So when will they publish the results and tell us the good news?

 

Probably sometime in 2021...

 

I pray to God that Regain goes to Phase 3 after they are done with Phase 2.

Anyone know how Regain/Audion fast track status works? If they go to Phase 3 can they release the drug after that or will there be a Phase 4?

 

You should maybe read up a little on clinical trials in general. There is no such thing as phase 4.

Sometimes there are two or more separate phase 3 trials though like was the case with AM-101... but they did that because they changed the outcome measures trying to get the trial to be successful, and yet ended up failing.

 

That’s good to hear. I do think Regain works so I don’t think they would have to do any extra. Just Phase 2 and 3, then release to the market.

 

Phase 4 is where a drug is released to the market but the company has to follow it and acquire data.

 

A rough timetable taking into account the time passed between previous studies and the current Phase 2 study could look something like this:

Phase 2a - October 2019 to September 2020 (how many injections?)
Phase 2b - April 2021 to May 2022 (maximum amount of injections per Phase 2a, possibly expanding to >70 dB hearing loss)
Phase 3 - December 2022 to February 2024 (larger patient population)
FDA approval - March 24 to September 24

And this all dependent on the Fast Track status, what they find in trials etc. They started with Phase 1 in 2017 so this would still be pretty fast. I think 2025 would be more realistic.

 

Would it still be possible that after Phase 2a they will go to Phase 3?

When do you think they will let us know if it helps with tinnitus and hyperacusis? You reckon at the end of Phase 3 or when the drug gets released?

What about pricing wise. How much do you think it will cost us?