Otonomy OTO-413 — Treatment of Hidden Hearing Loss

Getting into the festive spirit!

 

Looks promising.

 

Where is the hype people!?!?

Clinically meaningful improvements!!!!!!

 

What's interesting is for OTO-413, as was reported today, the placebo also had more side effects.

What are they using for placebo I wonder?

 

The data looks promising. I'm curious if there is oversight by objective third party experts/researchers in the areas of specialization.

 

There is. The outcomes assessors (who do the follow-up tests) are independent of the FDA and Otonomy.

 

Looking at the corporate presentation @patorjk posted, those are strong results but I wonder if they would have gotten even better results if they had excluded the moderate to severe hearing loss group since that group likely had more inner hair cell loss.

Anyway these results look good. I think the hype train will wake up when more people in more time zones do.

 

These trials are all done by outside testing centers so yes. None of it is done in house by Otonomy.

 

Sorry... is this better?

 

There is evidence of restoration. They restored some hearing function, which means they restored some hearing structures.

That is what we’re all waiting for. Restoration. I don’t know about y’all, but I’m dancing around in my underwear.

 

This should definitely be asked in the Tinnitus Talk Podcast. Great news however, hopefully they push this thing forward now.

 

That would be a good thing to ask. Make sure you submit that question.

 

Partial hype train passenger here. Post beer tonight might be full hype train passenger.

What type of time frame are we looking at here? I assume a minimum of two years?

 

I'd put it closer to 3. If they stick with a 90-day assessment period, the trials should go quickly. They haven't announced a Phase 2 to my knowledge, and FDA Fast Track could help things along.

Warning: speculation ahead...

Phase 2: 2021-Q2 - 2022-Q2
Phase 3: 2023
FDA approval: 2024

 

I’m going to choose to believe in Fast Track and that it arrives on Christmas Day 2022 along with FX-322.

 

LET'S GOOOOOO!!!!! 3 years until no more hearing issues and we can sit in silent rooms again.

 

It’s still a very long time. I hope OTO-413 is successful but we would all prefer to take FX-322 if it ends up helping with hyperacusis and tinnitus but at least there are different drugs that are working on different areas in the ear so we would know more about what works and what doesn’t.

 

Great news. Otonomy is also 50 cents up on NASDAQ since the announcement, although I'm surprised it hasn't gone higher than that.

 

I would say that's pretty conservative. I would shorten Phase 2 a bit. I would say approval in 2023 is my bet.

 

I like your optimism.

I like your optimism.

 

The important thing here is two hearing drugs with clinically significant outcomes are in the pipeline.

 

They also did a conference call this morning, it's kind of long but you can listen to it here:

https://edge.media-server.com/mmc/p/nh3ph6tm

- They talk a little bit about the durability (they measured people at day 57 and 85), apparently some patients were still improving at day 85, so that's a good sign.
- They want to see if they can up the dosage for Phase 2. However, they want to examine all the of the data before they make that decision.
- 11 people got a high dose, but only 9 counted for the data in their slides. One of the 2 that didn't get counted didn't get measured at day 57 but did get measured at day 85. At day 85 they saw meaningful improvement.
- The patients took a lot of different tests, requiring hours of their time.
- Lots of data is still left to be processed. We'll probably get another report on the data sometime later.

We'll unfortunately probably need both.

It's been a roller coaster. As I'm typing this it's now up 9%, but at one point pre-market it was down 10%. The stock was run up around 40-50% in the last month. So it may have been overvalued. It makes me a wonder if something similar will happen to Frequency Therapeutics. It's being run up like crazy right now.

 

My understanding is that Otonomy believes that their delivery method is superior to something like FX-322. Is there any information released anywhere on how deep into the cochlea they believe that their drugs can be effective?

Basically, do we know if there is a lower frequency threshold at which OTO-413 starts to become less effective? Or is this the data that would be expected to come out of a more involved phase 2 trial?

 

Am I on the only one really satisfied with the fact that the placebos saw zero improvements (in the clinically meaningful sense)? It's not surprising, but it's a pretty big form of validation to people with hidden hearing loss. It doesn't quite validate hyperacusis and tinnitus, but it's a start.

 

They believe it's superior based on higher concentration for longer because it's in an extended release gel (which mimics repeat dosing even better than Frequency Therapeutics, it's like getting more doses, more often). There is no reason Frequency Therapeutics couldn't later put theirs in an extended release formulation.

 

This is amazing news!

It seems that they are onto something. I imagine bigger pharmaceutical companies are watching this. If there is a real avenue of treatment the pace of research will skyrocket in the next few years.

 

Nope. Not the only one. That is extremely validating.

 

This is about the best thing that could happen. Having the placebos fail means that there tends to be little or no way where those against these types of medicines could consequently criticise their effectiveness and/or validity.

 

I think that this also validates Otonomy's claims pre-trial that the high dose would provide the greatest response with outcomes and also actually seems safe as well.

Obviously Otonomy has really good claims to proceed with the higher dose and hopefully obtain approval to use an even bigger dose in future trials.