Acousia Therapeutics

Hm, it worries me a bit that they call it ”otoprotective” though, and not restorative.

 

It looks like they are doing separate trials for different causes. See here:

https://www.acousia.com/programs/

The noise induced trial is still pre-clinical so probably 20 years away

Getting on the trial could work though or maybe they will do compassionate use.

 

A potassium channel agonist protects hearing function and promotes outer hair cell survival in a mouse model for age-related hearing loss

New research on this pharmaceutical. It is apparently a potassium channel 7.4 modulator similar to Trobalt.

@Padraigh Griffin, you might be interested. Trobalt gets mentioned several times in the article while apparently this is an intratympatic form with more sustained outcomes.

 

Hearing loss company Acousia Therapeutics to present data for lead candidates ACOU085 & ACOU082 at ARO 2023 MidWinter Meeting February 11–15

Acousia Therapeutics GmbH, and its partners from the Translational Hearing Research Group at the Tübingen Hearing Research Center (Department of Otolaryngology, Head and Neck Surgery, University of Tübingen), will present data on its lead candidates — clinical stage ACOU085 and late preclinical stage ACOU082 — in two presentations at the 46th Annual MidWinter Meeting of the Association for Research in Otolaryngology in Orlando (FL) on February 11–15, 2023.

Both programs show positive results, which can already be seen on the website of the conference. And ACOU0082 is under research for tinnitus too.

Conclusions: In summary, chronic systemic ACOU082 treatment not only significantly reduces age-related hearing loss progression in SAMP8 mice with a clinically relevant effect size compared to vehicle controls, but also significantly enhances hearing sensitivity after short term treatment, consistent with the Kv7.4 target mechanism of action. This unique dual benefit of both enhancing and preserving hearing supports the high potential of developing ACOU082 as a drug candidate for chronic and progressive hearing loss disorders.

 

I live only 100 miles from Acousia Therapeutics. I had a phone call with one of the managers about 9 months ago. He told me that I couldn't take part in the study (I'm in my early 40s). The study is for age-related hearing loss.

Let's see, tinnitus is somehow genetic in my family, maybe I'll bring my father into the study with moderate hearing loss and severe tinnitus. If it improves his tinnitus, he won't be allowed to talk about it, but I would get a hint that maybe something groundbreaking is coming.

Can someone explain what the below means (I have trouble concentrating with my tinnitus)?

"Kv7.4 channels are strongly expressed in the sensory outer hair cells of the cochlea, where they not only influence outer hair cell amplification and frequency discrimination to maintain hearing function, but also provide homeostatic resistance to deleterious insults like drug-induced ototoxicity, noise exposure, and aging."

 

Kv 7.4 cells are present in the ear so Kv 7.4 targeted medicine can directly attach to the desired location. That's why it can be done with local injection instead of systemic treatment. Local treatment has fewer side effects. It explains that Kv 7.4 cells are involved in resilience and conserving of hearing.

 

Not seen you around in a while @Philip83. Hope you're keeping well and that the hearing aids are continuing to work for you.

In any case, should you ever read this post, you can allay your fears (at least where the prospects are concerned):

For while ACOU085 is designed to possibly treat

ACOU082 has the potential to

(presumably not in the sense of inflating hyperacusis symptoms)

and

▲ Taken from the Acousia Therapeutics latest website update, which cites a significant sharing of data at The Association for Research in Otolaryngology (ARO) 2023 MidWinter Conference, which @InNeedOfHelp has shared.

Speaking of which.

I notice they're putting a lot of emphasis on otoprotective capability against "age-related hearing loss", as opposed the entire gamut of catalysts they referred to last year.

Not that that would be a big deal, as I'd be grateful for any drug that could even somewhat restore hearing and mitigate one facet of its degradation.

However, I won't be able to hide my disappointment (several years from now) if ACOU085 doesn't make it, or do just half the stuff it's been hyped to do; because this is the drug (by description) I've been waiting on to give me back what's left of my life.





https://www.tinnitustalk.com/members/anthonymcdonald.45988/#profile-post-33031

 

Hey, thanks for the thorough update! Sounds extremely promising, but also after 22 years of tinnitus I’ve learned to manage my expectations Do you know if there’s any information about upcoming trials?

Actually, I’m 5 weeks into a spike after a moderate noise blast from headphones (I have to use them for work as a video editor). I’m still hoping it’s just a spike and not chronic though, as I’ve gone through this exact experience before. My (3?) tinnitus tones are just louder and more intrusive, but I can’t hear any new tones. Hyperacusis is back up too which is the most annoying part. Hearing aids are helping some, but not as much as they did initially, although that might be because of the spike at the moment. Noxacusis goes down by about 20-30% when I put them in, while it used to go down by 80%.

@InNeedOfHelp, @Hazel: do you know if it’s possible to read / watch their presentation from the conference anywhere? Did they say something about when Phase 2 for age-related hearing loss would commence? Thanks!

 

Yeah, @Brian Newman and @attheedgeofscience's posts (former/latter) sum the situation up quite well. Anyone not just discovering aural illness and this community, will have every reason to be extremely pessimistic and nonplussed by sensational claims relating to tinnitus and hearing loss treatments, from this point on.

That said, where's the fun in that?

My personals position: I'm not going anywhere, and I haven't really been excited by news of a drug or procedure that might help tinnitus and hyperacusis since the days of Auris Medical.

So I'll just continue to live as if no cavalry are ever arriving, while stubbornly continuing to hope, and contribute to, the far-fetched notion that one day I can pop a pill or take an injection (in the ear) that allows me to leave my apartment without hearing protection on (or even better: never have to listen to the glass orchestra playing in my head again).

Ah, sorry to hear this.

If it's any comfort, I have also had tinnitus for a while now (19 years) - although I only advertise the last 13 in my profile (because 2009 is when I began suffering) - and my experience in that time has been that the odd sound exposure (that occurs when you drop the ball while taking necessary precaution) does not result in a permanent worsening all that frequently.

Latest news on their website shows completion of Phase 1 Trials for ACOU085 (the otoprotective drug used alongside cancer medication) ▼

But nothing regarding ACOU082 (the one I'm interested in), besides what @InNeedOfHelp already posted.

I have sent them an email politely requesting that if they have the time, could they please give us some further information about what's going on with it (although I don't expect anything back soon).

I'll let you know if/when I receive something.

 

Same here. It's an acceptance that the cavalry ain't coming. Subtly different to 'habituation', which is so 2017.

 

Sounds very similar to my experience. My daily suffering started after a trauma in 2014, and since then I've had three additional chronic increases (two caused new tinnitus tones and one worsened my hyperacusis only, for some reason). I've had plenty of spikes along the way too though, lasting weeks.

Yep, same here. My hope is I'll have some relief within 10 years.

Side note on the hearing protection: I cannot live without my AirPods Pro. You can turn the ANC off with a click, which is very useful, and the stigma is less than wearing earplugs I guess and having to explain that to every other person. The new versions that came out a few weeks back are insanely good. When flying I literally cannot hear the plane if I put them in just right. It's baffling how good the ANC is. I don't leave my house without them.

 

Response today from Tim Bölke (CEO and CMO of Acousia Therapeutics).

 

hopefully if Dr. Shore's device pulls through, getting responses like that will no longer break our hearts.

 

2025 is a long time away.

 

Maybe if it was Phase 3 of a human clinical trial, I could hold out, but this isn't even that.

 

True. However, ACOU085 is moving into Phase 2 trials this year, which, providing it does well, will increase the expediency of, and funding for, ACOU083.

So Acousia's progression is still worth watching. If not just for the purpose of gauging how feasible/effective ACOU083 and future otoprotective drugs might be, then to judge (in the case of success) how long we might be waiting for what is of interest to us.

A direct hit on the first shot is going to be the difference between (roughly) three and seven years.

 

Agreed. Any meaningful progress in this field of medicine in general would result in massive attention and subsequently funding.

 

I think NAC is the only proven otoprotective drug on the market and it's actually still sold as a supplement currently. There are rumours it's going to be moved up to drug classification soon though.

 

Looks like they are moving onto Phase 2 with ACOU085!

Hearing Loss Company Acousia Therapeutics Green Lighted for Game-Changing Phase 2 Trial

This being a selective Kv7.4 activator is very interesting to me. I wonder how selective it is compared to Trobalt. If we also need to modulate Kv7.4 channels SELECTIVELY for the elimination of tinnitus, maybe this drug can help with that.

I hope the trials don't go wrong and in the case they do, they could find other uses for this drug so that it can be on the market one day. It would be real bad for the only selective Kv7.4 drug to be scrapped because of failed trials.

 

Does NAC help with hyperacusis?

 

I'm confused, do they investigate the drug only for Cisplatin induced hearing loss as this article says? I read some of the previous threads and I got the impression that the drug was developed to treat hearing loss in general. Maybe I'm wrong.

Kind of a bummer if they narrowed it down to only a treatment against Cisplatin. But better than nothing I guess.

 

No, this hearing loss is the same as any other hearing loss. For a clinical trial you need to narrow down a sickness/situation that is the same "incident" for all patients. If you would test noise exposure, all participants have different exposure, different incident and different impact. Here everyone gets the same drug (Cisplatin) matched to your body weight. Everyone receives the same dose per kg which will potentially harm the hair cells.

The same goes for the VX-548 trial for pain after bunionectomy surgery. Everyone has the same incident / surgery to have an objective analysis for impact on pain/nervous system. This does not mean that the drug only works for bunionectomy related pain.

 

Make sure you’re taking Glycine with that NAC. Both are needed to form Glutathione within a cell, and NAC is the rate limiting step... People dose up on so much NAC they deplete their Glycine.

Good luck.

 

Hearing loss company Acousia announces first patient enrolled in its Phase 2 PROHEAR-Study

It's a bit old news, but it hasn't been shared here yet.