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I watched @Hazel's video and all I saw was a privileged white person being a gatekeeper of the most important information this forum has to offer. There are other ways to do fundraising that don’t resort to censoring information for those who have limited to no financial resources. Tinnitus...

I’m not sure this will be addressed in their next conference. This study was based on a Safety dose, not a Therapeutic dose. They still had to play it safe at this point, so I doubt the amount they injected was the maximum volume with the maximum concentration of the drug in order to accurately...

“Although further development of the GSI inhibitor is required, the REGAIN project has helped shape the developmental and regulatory processes towards novel hearing loss treatments. Partners plan to conduct additional clinical studies in collaboration with other research groups active in the...

The lower the Hz number, the farther the drug has to travel. In the example above, 3500Hz is a considerably longer distance FX-322 has to go to reach than 6000Hz. The updated slide is a bad thing as it stands now, but more clarity on the information is needed to provide better context.

I agree, if we can ask about this in the upcoming Tinnitus Talk Podcast with Frequency Therapeutics that would be amazing. I might be reaching here, but they put labels at the bottom of the slide directly referring to Phase I/II studies, so based on the results we observed, this is consistent...

Frequency Therapeutics updated the slides to their corporate presentation. One meaningful change I noticed is on slide 15. The diagram now shows the concentration of FX-322 only reaching shy of 6000Hz, whereas before, this same diagram illustrated it as reaching past 4000Hz. Source...

I think it would be really great if we had the Tinnitus Talk Podcast reach out to Jeff Karp. He’s extremely receptive and a kind human being and I think it would be awesome if our community here was able to put a list together of 10 or so solid questions to ask him about. Just a thought.

Just wanted to add to this list that someone asked a question with regards to “durability” of the improvements seen in treated patients and both Chris Loose and David Lucchino said that are very confident that any improvements gained will last longer than the 7-Month window they’re observing...

Did they convey how much they increased the concentration from the phase 1b trial, or did they convey how much they’re increasing the volume? I’ve looked extensively to find this information and haven’t come across anything in writing yet.

I guess I had higher hopes this could help people with hearing loss lower than 4000 Hz.

Frequency Therapeutics may be backtracking a little bit. On Slide 11: “FX-322 designed to enable hearing in higher frequency ranges critical for understanding speech”. Slide 22 & 23 provide a diagram that illustrates FX-322 has highest concentrations just past 4000 Hz.

Frequency posted a detailed corporate presentation this morning: https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1

If you hear back from them, can you ask them about the volume of drug they’ll be injecting and ask them if they’ve increased the concentration of the drug from the amount that was used in Phase 1b? I called the Fresno facility yesterday and haven’t heard back, but I’m planning on asking as...

It infuriates me that there’s no information with regards to the volume or concentration of FX-322 being injected in the 4 investigational groups.

Kicking off: https://www.globenewswire.com/news-release/2019/09/17/1916561/0/en/Otonomy-Initiating-Phase-1-2-Clinical-Trial-of-OTO-413-in-Hearing-Loss.html

I’ve thought a lot about Astella after reading the IPO document. Here are some of my thoughts: 1) I call bullshit on Frequency Therapeutics not testing hearing out to 20 kHz. Langer, Karp, McLean, et al, they all know an extraordinary amount about hearing biology, enough so that they were able...

I think there’s room to be optimistic here. Frequency’s largest administered dose in this study was 0.2 milliliters of FX-322. Audion stated in their GSI study that the maximum volume of solution allowed in the cochlea was 500 micro-liters. If you convert 500 micro-liters to milliliters, you...

In cases of cisplatin induced ototoxicity, yes, but in cases of gentimicen I believe in only kills the hair cells themselves. I could be wrong though, but I haven’t investigated this fully.

In the 2nd diagram, what year was this created? Where is the literature you pulled this from? I’m curious, did the verbiage mention what happens to the Tunnel of Corti between B and C in this diagram?

I honestly believe there’s hope for FX-322 treating ototoxicity damage. In their 2017 paper they treated hair cells that were deliberately damaged with gentimicen and were able to restore the hair cells upon exposing them to FX-322. Also, their drug activates a chemical cascade of events that...

I’m sorry for your situation. Have you given any thought to FX-322? They’re gonna be enrolling for Phase 2a here in the next couple months. Based on the inclusion criteria for Phase 1B you’d be a perfect candidate for this trial. Best of luck to you. We’re all in this together.

This individual’s anecdote is here-say, and this anecdote is supported by an “anonymous source”, and within this anecdote there exists inaccurate information. This is what I’m pointing out. Semantics are important, but go ahead and believe everything that you read.

The drug isn’t a gel-like substance, it’s a liquid: “This is the first time the study drug LY3056480 will be tested in people. The study drug is a liquid that must be delivered to the inner ear, through the eardrum using a syringe.”

This article was written based off an interview that was done yesterday, but they specifically state in the article that Frequency Therapeutics is headed for a Phase IIa later this year. Looks like Phase II is going to be broken up into two parts, and not just a single blanket Phase II trial...

Audion is REGAIN

The presentation Frequency is doing in September is only going to be 5min long. That’s a less than inspirational time slot.

“There has been some success in hair cell regeneration following Wnt and Notch modulation in the mature mammalian cochlea.34,52 However, it is important to note that many of these newly generated hair cells show limited survival and do not appear to fully differentiate, lacking mature...

https://www.cell.com/molecular-therapy-family/molecular-therapy/pdf/S1525-0016(19)30111-X.pdf Review of current pharmacological approaches to treating hair cell regeneration. Audion, FX-322, and CGF166 are all reviewed with perspectives of where research stands today, and where it needs to go...

I think it’s important to point out that there are still no results posted from the Phase I they did in Australia well over a year ago, so everyone expecting something to be posted from the Phase 1.5 should adjust their expectations accordingly. Both were “safety” studies.

I guess what I can’t wrap my head around is why Frequency didn’t attempt a multiple dose approach in this 1.5 study if they had any inclination that a single dose administration wouldn’t do the trick. Audion, although a different type of drug, administered their treatment in 3 doses per patient...

@Aaron123 welcome back man, it’s good to see you.

I get that, but I think what I’m trying to say more clearly is this: David Lucchino mentioned in an interview that a 10 dB improvement is a clinically significant event. I’m guessing they didn’t see this clinically significant improvement happen in the individuals who received the high dose...

I agree with your logic to some degree, but I think it’s important to note that Frequency Therapeutics for the longest time pushed this whole notion of a single dose administration. They have completely backtracked on this approach. This causes me some concern that the drug isn’t as effective as...

They can start Phase II before the Ib results get posted to the public. Unless something negative happened in Ib.

They still technically have no drugs in their pipeline. Just an investigational drug to combat ototoxicity. Decibel is a very long way off from making an impact. All this money, all these partnerships, and not even a phase 1 drug of any sorts. I appreciate their efforts toward research, but...

I live in San Francisco and I’ve tried reaching out to the venue administrators as well as the JP Morgan contacts for this event. This conference is exclusive to affiliated investors and individuals who have ties to JP Morgan. If anyone in this thread works for JP Morgan, or has family...

Molecular characterization and prospective isolation of human fetal cochlear hair cell progenitors https://www.nature.com/articles/s41467-018-06334-7

@Jason37 @Deathtotinni Since the both of you almost made it into the trials, can either of you provide us information on what specific unit of increments these doses were administered in? For example, was “Low Dose” 5mg/ml of X, or 20mg/ml of Y? It would help us all track this if we have a...

Hang in there. 2019 is going to be the Year of the Ear. A lot of movement will come to fruition this coming calendar year. Keep your head up.

Can you elaborate further on the bit about dosage? Can you elaborate further on why they believe that altering the mechanical parts of your inner ear might have negative impact? Since you bowed out, did you have to sign a NDA? What questions did you ask them during their screening process?

This thread is going off on an extreme tangent. Unfortunately, I’m going to contribute an opinion that feeds into this against my better judgement. Please feel free to flag this and have it removed for being slightly off topic. Here’s my current thought on FX-322 and it’s competition: who is...

I didn’t see this posted yet, but Otonomy updated their website with the PowerPoint/Slideshow from the post @Tigo provided earlier: http://investors.otonomy.com/static-files/cdfa5ab7-2975-46cf-81a5-5e0ef5a16c15 The second to last slide is the most interesting.

Mild hearing loss and moderate hearing loss are part of the current criterion for their target group as it stands today, and these are the two groups they feel will both benefit from FX-322 if it works. Lucchino’s offhand comment about FX-322 potentially benefiting cochlear implant candidates...

I was just about to post this link, but here are a few things Lucchino mentioned: - Frequency Therapeutics won’t be looking at the data from this current trial until early next calendar year - Lucchino made a offhand statement that FX-322 might be able to help those with severe hearing loss...

This is a research update forum. This is NOT a support forum. There is a forum here coincidentally called “Support”. Please find your way there.

This is misinformation at best. FX-322 does NOT create new supporting cells. FX-322 makes a copy of an existing supporting cell, and that additional copy differentiates into a hair cell. The initial supporting cell that was copied in the first place remains intact and presumes its normal...

I, too, am most worried about what @Contrast said. That a healthy HC, but with retracted ribbon synapses, will not get regenerated, thus this drug will be futile for this kind of damage. Hopefully OTO-413 will fix the issue above. I am concerned that the cascading of chemical signals that...

Thank you.

Does anyone have another means of contacting him? Social media, email, messenger pigeon?

For what it’s worth, based on Frequency’s latest press release they mentioned pushing this drug into a “Phase 2a” early next calendar year. I personally wasn’t quite clear on what a “2a” is, so here’s the breakdown: Phase IIa: Pilot clinical trials to evaluate efficacy ( and safety) in selected...

Will McClean briefly talks about hearing restoration and other applications of his work: https://www.technologyreview.com/video/612059/2018-innovator-under-35-will-mclean/

This is all very compelling information on Frequency Therapeutics. Keep up the great content guys.

Frequency has stated on multiple occasions that FX-322 is comprised of inexpensive materials that are readily available and easy to manufacture. All this points toward an inexpensive product. However, a set of very top of the line hearing aids can run you approximately $6k (American). Given that...

https://endpts.com/nea-5am-back-a-50m-play-to-steer-gene-therapies-to-the-clinic-at-akouos-the-latest-startup-in-hearing/ Akouos has significantly expanded their platform profile to include multiple forms of hearing loss. This technology appears to be a robust evolution of what Genvec (CGF166)...

https://www.in-pharmatechnologist.com/Article/2018/08/09/Frequency-sounds-out-progenitor-cell-activation-for-hearing-restoration Carl LeBel of Frequency discusses the design of the current trial in an interview.

http://frequencytx.com/news-events/news-events-press-release-08-14-2018.php Frequency has added additional scientists to their regenerative medicine board.

I think it’s also important to keep in mind, too, that Frequency is a privately funded startup that has MIT’s and Harvard’s brightest scientists at the helm of their science board. This is a significant factor to take into consideration. Companies that seek public investment do so to decrease...

I think there’s reason to be very positive here. 1/3 of the participants in this 1.5 trial are receiving a high dose. This is VERY significant and they are going to be watching this group closely. Even though hearing improvement isn’t in the primary outcome measures yet, they did specifically...

3 groups. High Dose: 8 participants Low Dose: 8 participants Placebo: 8 Participants That’s a 67% chance of receiving the drug. Also, I find it very interesting they’re utilizing a high dose this early in the study. I’m very curious to see if FX-322 is believed to have therapeutic...

Jeff Karp stated in a podcast last year that they expect the treatment to have long lasting effects if it works in the first place. We also don’t know exactly how long it takes for the inner ear cell regeneration to occur. It could take weeks or months.