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It's quoted above. Here are the results and conclusion: It acknowledges there was a placebo effect (something that appears to be true for all tinnitus trials), but it says there is sufficient proof of concept to support future investigation.

Now that this study is over and showed promising results, does anyone know if there is any active research into micro-dosing MDMA as a cure/reducer of tinnitus? For some reason I've been thinking about this the past few days. I've read many reports of the drug reducing tinnitus, and it seems...

Decibel Therapeutics (now owned by Regeneron) has a similar drug and made a press release regarding similarly good news back in October. Both Decibel Therapeutics and Akouos are aiming to tackle smaller hearing diseases as they work their way up to a cure for general hearing loss. This early...

I decided to dig around and see if there was any news from DB-OTO study and I found this press release from Regeneron that indicated some initial success: A placebo effect for this kind of hearing loss is unlikely, especially for a child that probably doesn't even know what's happening. I...

Decibel Therapeutics announced this morning that they're being acquired by Regeneron. The deal is $4 per share plus $3.5 per share in CVR (contingent value right). According to the agreement the CVR is: The first $2 seems pretty likely given that the DB-OTO trial has already started. Hopefully...

About 2 weeks before the FX-322's Phase 2b data release, the CEO retweeted these tweets: I think this gives us the best insight into what he was thinking. Prior to knowing the results, the company probably drew out 2 paths forward: 1) Positive results: Push forward with FX-322 into Phase 3...

Gene therapy is one avenue that's being explored. The two main companies (that I'm aware of) in this space are Decibel Therapeutics and Akouos. Akouos got acquired by Eil Lilly last year for a huge premium, which tells me that the major players see this as a fruitful avenue. Both companies are...

They did a one-year follow up on the Phase 1/2 trial participants and the effects at 90 days had significantly lessened. They did a similar long term follow-up for the Phase 1b open-label study (I think it was at the 6th or 9th month mark) and a similar thing was observed, though I think 1...

He was asked about this on Twitter and replied "No plan to do that. Not convinced that drug delivery was FX-322’s only challenge". I found this kind of interesting since his thread on FX-322 failing focused mostly on drug delivery, and didn't mention anything else. Also of note is that his...

Elsewhere on Twitter he says (in regards to a hearing drug) "We’ve been testing a wide range of approaches in the lab. Might have something ready for the clinic in 2024" and "Biggest challenge is nailing the clinical application. What are relevant endpoints that lead to a reasonable study design...

As I said in my previous post, their current drug candidate, SPT-2101, is dexamethasone - which is what Otonomy's Ovitidex was. If SPT-2101 shows improvements better than Otividex, then their drug delivery tech may be the real deal and there may be some real hope for OTO-413. As for them trying...

I unfortunately can't find any info on it. I did find this press release though, which talks about the Phase 1 and Phase 2 studies of SPT-2101. Further digging shows they have around 18.5M in funding. Their website is really light on info though. I'm guessing they're just too early stage at the...

Great news everyone, the CEO of Spiral Therapeutics just tweeted that their plan is indeed to see if BDNF works with their delivery method. OTO-413 isn't quite dead yet. He said this in a thread where he discussed why he thought FX-322 failed. I wonder if his company will try to acquire the...

They did, but they didn't expect a response from them, they just did them for safety reasons. Here's what they told me when I emailed them back in 2021: Thanks for the question. We are still doing standard audiograms as part of the safety assessment. For preclinical studies, we used auditory...

My guess is they'll take a close look at all of the data they're given to see if they think BDNF is viable to move forward with. I assume they're not going to be using Otonomy's delivery method. There's no way to know though. They only paid $250k for it, so it's kind of like a moonshot for them...

I don't know, the liquidation has been moving along though. I honestly don't expect us to hear much for a while. I still don't understand why one company bought the assets and rights, and another bought the patents. It could be that Spiral Therapeutics has no intention of reviving the program...

Two months ago Frequency Therapeutics did a story with CBS that featured a former trial patient saying they got "84%" of their hearing back. It's now less than 2 months later and they've shut down all of their hearing programs and scrubbed their website of most of their hearing drug related...

The cancelling of FX-345 was the only thing that shocked me with today's press release. I had kind of expected FX-322 to fail again. The data from the previous studies wasn't great, and was in fact it was weaker than Otonomy's OTO-413 data, so I felt there was a good chance it would either fail...

Around 2 weeks ago, David Lucchino, the CEO of Frequency Therapeutics, made 2 retweets which I thought were odd and with hindsight seem even stranger. Retweet #1: Retweet #2: I wonder, at the time he made these, did he know the results or have an idea of what they might be? It seems like...

The news is out. Looks like it's bad. "The study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of an improvement in speech perception. Data showed no statistically meaningful difference at day 90...

As an aside, Michelle Solly, a biotech analyst on Twitter, did a really good write-up on Frequency Therapeutics 2 years ago, right before the Phase 2a results. Her analysis is on the original Phase 1/2 trial, but she brought up a lot of points that weren't actively being discussed at the time...

OTO-6XX was initially a joint program with Kyorin. Otonomy paid them $1M for a compound that regenerated hair cells in a preclincial model. However, further preclincial work didn't pan out. They then pivoted to hair cell repair. This was what they were working on prior to the company closing.

OTO-825 was picked up by Prevail Therapeutics, which is an affiliate of Eil Lilly: On January 27, 2023, Otonomy entered into an asset purchase agreement with Prevail Therapeutics Inc., an affiliate of Eli Lilly and Company (“Prevail”), pursuant to which Otonomy agreed to sell and assign to...

I mentioned this in the OTO-413 thread, but Spiral Therapeutics is acquiring the rights to several parts of Otonomy's pipeline, including Otividex (the failed Ménière's disease drug), OTO-510 (otoprotectant drug related to Cisplatin), and OTO-413 (hearing/synapses). On their website they...

A bit of news on this company: Last October they were acquired by Eli Lilly, a large pharmaceutical company. It's interesting to see such a large player enter this space. It's also curious why they picked Akouos. Other than the delivery tech discussed here, I don't see what's so compelling -...

Otonomy released an SEC form today that detailed how they're selling off their assets. Here's the info related to OTO-413: On January 23, 2023, Otonomy entered into an asset purchase agreement with Spiral Therapeutics Inc. (“Spiral”) pursuant to which Otonomy agreed to sell and assign to Spiral...

From the data we've seen in the previous studies, for those with moderately-severe hearing loss, FX-322 won't restore 40% of their hearing. At best it will help them with word clarity - giving those people 10-20% better clarity in word recognition (with a few people being super responders and...

I think the odds are 50/50 - a coin flip basically. On one hand Phase 2a failed, along with several of their other Phase 1b trials. Insanity is doing the same thing over and over again and hoping for different results. On the other hand, they are targeting groups they think the drug helped. If...

I've been doing a deeper dive on this company recently, and I think I've found some interesting stuff. However, I kind of don't know what I'm looking at so I need other people to let me know if this is something to get excited about or if this is a nothing burger. Anyway, last summer, right...

I would be surprised if Otonomy isn't done after this. This is basically their 3rd strike. OTO-413's Phase 2a study data was promising, but with this higher dose study showing no benefit it throws that into question. I doubt there's much celebration at Frequency Therapeutics' HQ. They weren't...

It's believed that they contribute to the ability to hear clearly in noise. There are multiple synapses per hair cell, and they die off much sooner than hair cells. Having trouble hearing in noise is a chief complaint for people as they get older. With this news my hopes for this drug have...

Just got an alert email from Otonomy (I'm signed up on their website), they're laying off 55% of their staff to focus on OTO-413: Definitely a bit sad and not terribly encouraging, but I suppose this is a necessary step given their current condition.

When Otividex failed for the first time they cut 33% of their staff. They'll probably do something similar or more drastic this time. They have $53M in cash and they're burning around $25M every 6 months, so what they have now will only take them into the middle of next year. That's not long...

The problem was the placebo effect: It sounds like the higher dose trial did better, but the placebo effect was just too discouraging in the Phase 2 trial. I get the feeling we may be doomed until there's a better way of measuring tinnitus.

Yep, bad news.

Placebo effect, or even worse, someone saying something to pump the stock. Take anything you read online with a grain of salt. There were several good anecdotes about FX-322, and that flopped pretty hard (when compared to placebo). That said, the results aren't in. Right now the stock price is...

I was about to argue with you that they're highly correlated, but that may not be the case. I looked up the data for the PGIC in Phase 1/2: It's possible the placebo group had positive PGIC responders who had weak TFI scores. They don't tell us if the 40% non-unchanged participants were...

Maybe, the volume has been high. Lots of people are clearly heading for the exit. Though then again, it could be a self fulfilling prophecy. Everyone is on edge, someone decides to sell out and other people see them do that and think they know something so they sell out too, and it creates a...

I skimmed the paper, though didn't see anything about NMDA anagonists. It mentions the Sertraline study. I tried that but couldn't make it past day 3. It caused horrible side effects and made my tinnitus to go through the roof (I could hear it in the shower). It also mentions a surgical study...

They had two Phase 3 failures - TACTT2 and TACTT3. As of 2019 they still believed in the drug, however, they'd already burned through all of their funding. It's still listed on their website, so maybe at some point they'll revisit it? Years ago I read that gacyclidine (OTO-313) was a much...

I don't. I've searched before and come up empty handed. Otonomy did say the mini trials were exactly the same except for the higher dose. I'm not sure if they're not required to list them because the trial is so small, or if they can do the trial under their existing one. Their current clinical...

It's possible. In the pilot study it did this for one person. To quote from the case study: In addition, in their case studies for Phase I/II in their corporate presentation someone went from a TFI of ~80 to ~17 ("severe to mild"). When the data comes in for Phase 2 we'll see if there's anyone...

Otonomy's stock had some eye-popping volume today - 6x the normal amount. In the end there was only a 5% drop in share price, but it looks like investors are getting skittish after last night's earnings call. Not sure why or what to make of it. There were around 3 massive sales of over 100k...

I listened to their earnings call, nothing to report. No video feed in this one (sometimes they have video). I didn't get any weird vibes, though I didn't get any vibes indicating they know what's coming either, so it seems like management doesn't know anything yet. Possibility, though the...

Minor update: According to their latest press release, the two OTO-413 high dose studies ended up with 19 patients each: "Each higher dose cohort completed enrollment of 19 hearing loss patients randomized 2:1 to OTO-413 or placebo, with top-line results expected in the fourth quarter of 2022."...

They're running two mini-trials of 12 people each (8 get the drug, 4 get placebo). One is using 2.5 times the dose of OTO-413, and the other is using 5 times the dose of OTO-413 (compared to the Phase 2a trial). On March 1st of this year I emailed them about these trials (before the 5x dosing...

The drop was due to a Phase 3 failure in their Otividex drug. This drug was the reason their company was founded many years ago. It was supposed to help Meniere's disease, which their founder, Jay Lichter, suffers from (aside: he also has tinnitus). The rise in the stock from April '20 to...

It just means there aren’t a lot of people shorting the stock. You can read more about Short % of Float here. At this stage, unless there’s a spike in volume, I don’t expect the stock price to tell us anything. I’ll honestly be surprised if the results aren’t good. If they’re bad, I can see...

The volume (amount of stock trading hands) has been low or average recently. The drops are most likely people getting scared and exiting before the results are in. The Short % of Float is pretty low (0.83%), you'd think if someone knew something they'd be shorting the stock. Last year in...

OTO-825 is their gene therapy drug, it's for congenital hearing loss. OTO-413 regenerates synapses. It doesn't deal with glutamate or NMDA receptors (that's OTO-313). OTO-6XX was originally going to work like FX-322. Otonomy licensed a drug from Kyorin that worked in a similar fashion...

My daughter has ASD and ADHD. No tinnitus, but she's only 6. My dad, myself, and 2 of my brothers all have tinnitus (my 3rd brother died last year, not sure if he had tinnitus) - none of us have ASD though.

The original research, Effects of extracochlear gacyclidine perfusion on tinnitus in humans: a case series, involved only patients with acute tinnitus (less than 7 months) and unilateral tinnitus. Since treatment was successful in this (human) research, I'm guessing Otonomy wanted to stick...

I have a hard time understanding this too. Wouldn't they have seen only IHCs regenerated when they did their pre-clinical work? I think they're trying to reconcile what they believe is a real signal (the improvement of WR scores in 16-33% of patients) with no measurable audiometric improvements...

The data isn't there though, which is why the stock has crashed 85% in the past year (and that's on top of the 80% it crashed when Phase 2a failed). They did 3 Phase 1b trials last year, and all of them had poor results. Phase 1b-111 Open Label Trial: 34% response rate for 10% or more...

A fascinating self-study. One thing you both might want to try is Otonomy's sample Words-in-Noise test. They've already shown BDNF can improve hearing. Maybe take the test once a week and see if you notice any improvement in your hearing. If not, it may mean that not much BDNF is making it to...

Yeah, August for OTO-313, then in the months after that results for higher dose OTO-313 and OTO-413. FX-322 results will be late this year or early next year. FX-345 hasn't even started trials, though their goal is to start a Phase 1b trial in the second half of this year. As an aside, I came...

I spoke too soon, they released positive results this morning: Decibel Therapeutics Reports Positive Data from Interim Analysis of Ongoing Phase 1b Clinical Trial of DB-020 in Patients Receiving Cisplatin Chemotherapy Still a bit strange to wait so long, though maybe it took them a while to...

I'm starting to think the study had poor results. They have 3 more days to release the results before 2Q ends. It wouldn't make any sense to release good results right before a long holiday weekend. It's only 20 patients, so I can't imagine it would take a long time to process, especially since...

These are stock options, they give the person the right to buy the stock at a certain price. Frequency Therapeutics recently had its annual meeting of stockholders, and as part of this they gave the management team stock options. Otonomy and Decibel did the same thing this week. All 3 companies...

They've said they'll be releasing the data for the Phase 2 trial in August. They need to plan Phase 3 now to be able to hit the ground running as fast as possible. The study takes 16 weeks and they did a press release announcing the competition of enrollment on February 22. They probably...