The OTO-413 stuff starts at 27:08. I think it sounds interesting. The fact that he says it restored hearing function in animals is very interesting. I think I'd like to know more about how they know that. I did some googling and found a study done on guinea pigs [1]. It found:
So if it works in humans, it's probably not going to be some miracle drug. This may also be why Otonomy is focusing on speech-in-noise for their trial. It'll help with people hearing aids hear better. Also, since tinnitus is part of the exclusion criteria, so we won't know if it helps for that (I feel like it could - though with their focus on speech-in-noise, it makes sense from their perspective).
Honestly, I kind of wish Otonomy and Frequency Therapeutics would team up. From what the Otonomy CEO said, it sounds like they have the drug delivery part down (with a hydrogel the CEO claims is much better than anyone else's). Add that with OTO-413 and FX-322, and we'd possibly have something really amazing.
[1]
https://journalotohns.biomedcentral.com/articles/10.1186/s40463-020-00432-7
I think we will obviously have to wait and see what comes out with it when the clinical trials are done, however if OTO-413 provides positive benefits for synapses alone then it is incredible and it is going to be a winner. If it provides any additional benefit than solely synapse restoration then it is a bonus and it will also make this OTO-413 even more marvellous.
My view is that OTO-413 will be a winner as long as it provides benefit. The synapse benefit will likely be a winner within its own right. The current crop of hearing aids are absolutely useless when it comes to maximum speech in noise benefit. Thus just as you have stated, the benefits for hearing aid users will be immense. This will be because the devices can predominately be used for amplifying speech and actually not need to be used to eliminate background noise which they are largely poor at doing overall.
Obviously the hearing aid companies and also some audiologists are not going to like the success of synaptic based medication much like OTO-413. The predominant reason for this is that the hearing aids that tend to come with the background noise programs are premium devices that are usually in the more expensive end of the range ($4000-$5000 approximately.) Thus even without hair cell repair medicine, this is ultimately going to mean that the device costs could get cut in half.
Having a look at what we can get at the moment, you can find that the $1500-$2000 entry level products (which are usually fit by audiologists on people in places like nursing homes) which usually don't have the program functions required for speech in noise might now end up being super suitable for a lot of people too. This is because the entry level hearing aids are quite likely to meet the requirements of many users.
Therefore having a successful outcome with OTO-413 for synapse recovery would mean that the hearing aid companies could see a significant, sudden and deep drop in profitability. This would be because the additional benefits provided in the more expensive and higher end options could not be needed by most users too.
The partnership possibility between Otonomy and Frequency Therapeutics is quite plausible and also would be an excellent, logical also smart business decision, should both companies have success with OTO-413 and FX-322, respectively. The reality however (at least in the short-term/next few years) is that Frequency Therapeutics and Otonomy might not want to partner with each other due to their own benefits with their own medication. This is because both companies may see themselves as having the ability of maximising financial benefit through their own operations.
The reasons I believe that Frequency Therapeutics and Otonomy might wish to remain independent are as follow:
1. Although it is unlikely, both Otonomy and Frequency Therapeutics may possibly be able to provide full restoration with their own treatments.
Frequency Therapeutics is doing their own clinical trials around speech in noise benefit during the current phase 2a trial (as a secondary measure), while Otonomy obviously saw that there was benefit with more than just synapse repair in their lab experiments. Thus I cannot see either company being willing to collaborate until they have both eliminated full repair capabilities from their treatments.
2. Otonomy and Frequency Therapeutics may believe that they can maximise financial benefit from their products by remaining independent. This is because both companies may feel that if they simply go it alone, they can remain responsible for their own affairs like price setting and also the direction of their organisation.
Obviously there are financial and also business benefits by merging, such as only needing one set of operations and one manufacturing arm etc.
My opinion is that both companies could remain completely independent from each other from a management/operation perspective, however what they could do is link up in clinics and suggest people take each other's medications. For example patients might come in because they need FX-322 and then also discover that they would benefit from a synapse treatment. Maybe these clinics could then offer Otonomy's treatment as the preferred and/or recommended choice for this.
I think that the end result however would have to be financially beneficial for both companies to consider merging.
3. From what I have seen on Otonomy's website, they were also working on a hair cell treatment.
This is the biggest reason I can't see Frequency Therapeutics and Otonomy merging. If both entities are planning to offer the same treatment types, I cannot see them wanting to merge when Otonomy might feel that they are going to have a superior hair cell repair medicine. As a result Otonomy and Frequency Therapeutics might be competing for the same market share as a result.
Having said that, if Frequency Therapeutics is successful with their hair cell treatment and Otonomy doesn't feel they can do better with their equivalent, I think it would completely change the way both Otonomy and Frequency Therapeutics view a possible merger.
I think that ultimately a merger would be beneficial for both companies and also potential consumers if both Otonomy's OTO-413 and Frequency Therapeutics FX-322 were hugely successful treatments in their own right. I strongly believe that this would allow both companies to streamline operations not only from a business perspective but also to provide streamlined treatment for patients.