Otonomy OTO-6XX — Hair Cell Regeneration

Dear x,

Thank you for your inquiry regarding Otonomy’s clinical trials for hearing loss.

OTO-413: In February 2021, Otonomy announced plans to evaluate additional patients with hearing loss in an expansion of the Phase 1/2 clinical 3 trial that was initiated in September 2019. That part of the trial is planned to start in the second quarter of 2021.

OTO-510, OTO-6XX, and Gene Therapy (OTO-825) programs: Otonomy is currently not conducting clinical trials with these compounds as they are in the pre-clinical phase.

Please note Otonomy is not providing medical treatment advice. Any treatment-related questions regarding your condition should be directed to your healthcare provider. This information is being provided as a courtesy in response to your unsolicited request.

Otonomy is located in the United States and information through our Medical Information services is received in the United States. If you have questions about the privacy of your information, you may contact privacy@otonomy.com.

For any further questions, please contact Otonomy Medical Information at [insert phone number] between the hours of 8:00 AM to 7:00 PM ET (5:00 AM to 4:00 PM PT), Monday through Friday or via email at medinfo@otonomy.com.

Sincerely,
Alfred Tsiang, PharmD
Otonomy Medical Information

 

Otonomy is making progress, seems promising.

 

Man, you're such a downer.

 

The funny bit about his comment is that the exact response he got was that they are in preclinical. What his comment did not explain was how far away they are from concluding this aspect of the trial and progressing to clinical trials.

This is most likely because they do not want to make false claims about the progression.

 

I noticed some news that Otonomy slipped-in under the radar.

When I listened to the Tinnitus Talk Podcast with Otonomy last month I noticed that Dr. Weber mentioned they were looking into hair cell repair as well as regeneration. I don't have the exact quote, but the part about hair cell repair made me think they might be pivoting to another compound. However, when I look at their pipeline page today, it says this in regards to OTO-6XX:

OTO-6XX induces hair cell repair and regeneration and is being developed for the treatment of severe hearing loss. Otonomy has selected a lead compound for development.​

Wait, it induces hair cell repair? I swear it didn't always say that, and sure enough, if you look at archive.org, it didn't say repair back in February:

OTO-6XX induces hair cell regeneration and is being developed for the treatment of severe hearing loss. Otonomy has selected a lead compound for development.​

So while we still know very little, we know that between February and March of this year they discovered that this drug can repair as well as regenerate. They seemed a little restrained when it came to OTO-6XX news during the podcast (saying it wasn't ready for the clinic), but it's clear they've made some progress. I'm curious when their next update will be. In August it will be a year since they entered into a licensing agreement with Kyorin.

 

This might be a dumb question, but what's the difference between repairing and regenerating hair cells?

 

Good spotting that. It makes me wonder if they found proof that it repairs hair cells or they forgot to mention it.

Hopefully they still do OTO-313 and OTO-413 trials and release these drugs if they are successful.

 

There are a lot of ways these drugs could work. They could induce hair cell regeneration even if the cell doesn't need it, they could only work if the target cell was dead or gone, or ideally they'd target dead and damaged cells. Knowing that whatever they have works for damaged cells is a good sign. I also find it a bit interesting that it would repair rather than re-generate a damaged cell. Something in their pre-clinical work must have prompted them to make that sentence change.

I've been dying to know more about this drug, but Otonomy has shied away from talking too much about it. I'm guessing they want to have all of their ducks in a row before they move forward with it.

Another thing I noticed - Otonomy listed 5 new jobs on its LinkedIn page last month. None of them seemed directly related to OTO-6XX, but it's a good sign that they're hiring.

 

How long does it usually take for something to get out of the pre-clinical stage and into clinical?

 

I think it varies according to the company behind the product. I'm sure that they'll advance first OTO-413 and OTO-313 to get them to the market and after moving OTO-6XX to clinical trials. They'll have more data to successfully develop OTO-6XX.

 

They said in the Tinnitus Talk Podcast that they are prioritizing OTO-313 and OTO-413. They need lots of extra data (and perhaps resources?) to advance OTO-6XX.

 

They are also a lot further ahead with these two treatments too. OTO-313 and OTO-413 are in the trial phases. Then there's the fact that theoretically OTO-413 and OTO-313 are probably also going to assist with a wider and larger group.

We know OTO-6XX is still in the preclincial phase, however it is incredibly likely that this too will proceed to trials though unless some major failings happen to it. It is also the only treatment that Otonomy is in a partnership with a foreign pharmaceutical company for and therefore things will happen a little differently than if Otonomy was just dealing with this on their own.

 

Do you guys think this drug is actually going to work to restore hearing?

 

Yeah, of course.

 

Hello, what is the essential difference between OTO-6xx and FX-322? Is there any information that the gel in OTO-6xx is better than FX-322 when it comes to reaching below 6 kHz?

 

I propose a merger between the two companies. You know if one company has the best goods but poor delivery and the other has sub-standard goods but the best delivery method, what's the benefit of market competition and all that?

 

Interesting suggestion. Both companies would benefit immensely. The global market for hearing loss and tinnitus is huge and they would make huge profits. We hope that the damn manufacturers of hearing aids will not stop regenerative drugs because of their damn products... I hope that their impact is less compared to companies that produce drugs...

 

The thing that we don't know is whether the medicine manufactured by Frequency Therapeutics is actually more effective than the medicine produced by Kyorin/Otonomy.

We do know though that the chosen delivery method from Frequency Therapeutics in poor however.

It is incredibly unlikely that the hearing aid manufacturers will ever have a say in whether a medicine can or cannot be used to treat. The benefit attainable from a successful medicine will far outweigh the benefit from devices with the exception of when it would treat a conductive hearing loss, as it is not cochlear related.

Rather there are a lot within that industry like those at Cochlear and certain audiologists who would wholly prefer and support medicine. The same scenarios stands as it did previously which is that the only ones against ear medicines are the ones set to lose from them.

Then there's the secondary issue which is hearing aid manufacturers are also actually not liking the treatments that Cochlear or AB etc come up with because they are actually a threat to them already as they are not only far more effective but also legitimately look like being able to make further strides which will make them a more suitable option too. This is irrespective of whether medicine is or is not successful.

 

I hope that their lobby (hearing aid manufacturers) will not stop the regenerative approach to treating tinnitus and hearing loss.

 

I don't think that they will because there is firstly little rationale for the FDA to prevent such medicine from being approved and secondly even if they do succeed in stopping it in the USA for some strange reason, it is incredibly likely that approval will be attained in another jurisdiction anyhow. As a result, this would mean that the treatments would still come to market. Already we have seen this with the price of glasses dropping immensely after the introduction of LASIK and despite the claims made by optometrists about it when it was first provided.

Pretty positive that the evidence already points to the fact that there are a group of significant bodies involved with such medicines that have demonstrated that they are in favour of treatments with medicine.

 

Is the diagram from a human ear?

 

Why are they moving so slow with OTO-6XX?

Aren’t they concerned that OTO-413 might need OTO-6XX to have a substantial impact in studies...?

I find it strange they’re planning such a big time distance between the two.

 

I don't think that the issue is with Otonomy being slow but rather a combination of:

- only being able to deal with so much at one time

and

- the fact that OTO-6XX is still in the preclinical phase and is a lot further behind in its developments. For example the agreement with the firm who actually manufactured that medicine was only formally signed off on this year and this is one key component to progress to the subsequent aspects of the development.

 

Thanks for your input

Well I’m just going crazy so it’s depressing it takes time, and I see they do other things as well.

I just think these two treatments belongs together and I’m afraid we will never know because every company is running out of money.

Are you suggesting the firm that signed the manufacture contract will hand out cash already in Phase 1/2 and Phase 2?

 

Who is currently running out of cash?

No clue what is happening with it, however I have heard that they are getting funding from the other company to assist with OTO-6XX as it is their treatment. They are using Otonomy to get it trialled in the US and also as a result of their delivery technique.

 

I’m just very pessimistic these days, if FREQ and OTIC don’t show good results within 1-2 years I think they’ll slow down even more because of financial difficulties.

I didn’t realise OTO-6XX was a product from the other company.
I thought they were just to manufacture it if it got approval.

Thanks for clarifying!

Praying every day for good results!

 

I’m confused. Where did you hear this? Are you sure?

My understanding is that Otonomy is the one making payments, as part of a licensing agreement. The agreement gives Otonomy exclusive rights to the patented compound (specifically for hearing loss). Otonomy pays cash up front plus milestone payments (royalties), that sort of thing.

 

Can OTO-6XX cure tinnitus completely?

 

No one even knows if it works at all.

 

Why are OTO-313 and FX-322 so popular even though Hough Ear Institute's regenerating hair cell project is closer to commercialization?