Cilcare's CIL001 Targets Cochlear Synaptopathy — An American/French Collaboration

[Nick47]

'Cilcare expands its collaboration network to accelerate revolutionary treatment for cochlear synaptopathy with new clinical trial and biomarker innovation'

CIL001 is focusing on cochlear 'synaptopathy' — oh dear. Bad memories.

Cilcare's main website lists four products.

People may want to dig in to find out more...

 

[Fields]

Excerpt from a recent article on the New Scientist:

Previous work has shown that fibres and synapses can be coaxed to regrow by natural signalling molecules called neurotrophins. In the ear, focus has turned to one called neurotrophin-3, which normally promotes synapse formation in the ear in developing embryos, says Gabriel Corfas at the University of Michigan.

One hurdle is that neurotrophins are large protein molecules, which makes them hard to deliver to the inner ear, but there are possible workarounds. Corfas and his colleagues have used gene therapies to boost levels of neurotrophin-3 in the inner ears of mice, which leads to synapse growth. In one experiment, they were even able to give the animals more synapses than normal, which gave them superior hearing.

Niliksha Gunewardene at the Bionics Institute in Melbourne, Australia, and her colleagues have recently shown that in animals, an injection of neurotrophin-3-loaded nanoparticles into the ear releases the compound for several weeks.

Further along is a French firm called Cilcare, which has several drugs in the works that trigger production of multiple neurotrophins. Its lead compound — which Cilcare isn't yet identifying publicly — has already been shown to be safe in people when given orally for a different medical condition. The firm is due to start a trial next year in people with hidden hearing loss, with or without tinnitus.

 

[Nick47]

@Fields, that's a good find, along with Rinri Therapeutics, which uses stem cells to proliferate into auditory nerve cells. This is, though, distinct from synapses.

 

[gameover]

has already been shown to be safe in people when given orally for a different medical condition

Imagine we could take a pill and repair these nerves!

 

[Fields]

Imagine we could take a pill and repair these nerves!

I personally thought this was a little funny:

In one experiment, they were even able to give the animals more synapses than normal, which gave them superior hearing.

Imagine going from hearing loss and tinnitus on one end of the scale to not being able to sleep because of the crying baby three doors down the street on the other.

UNLIMITED SYNAPSES!

 

[Muggumbo]

Imagine we could take a pill and repair these nerves!

I'd take it even if it was a suppository!

 

[Utdmad89]

Imagine going from hearing loss and tinnitus on one end of the scale to not being able to sleep because of the crying baby three doors down the street on the other.

You don't have to imagine if you have hyperacusis, lol.

 

[gameover]

I personally thought this was a little funny:

Imagine going from hearing loss and tinnitus on one end of the scale to not being able to sleep because of the crying baby three doors down the street on the other.

UNLIMITED SYNAPSES!

View attachment 56778

Superior hearing would be like higher frequency range... it could create issues with some stuff. I'd gladly take this over tinnitus and fragile ears.

I'd take it even if it was a suppository!

Suppository would be so awesome! Like, hey my hearing turn to shit... but now we can use the asshole to fix it.

 

[F-u-T]

You don't have to imagine if you have hyperacusis, lol.

Hopefully, increased hearing would turn down the brain's central gain and reduce hyperacusis.

My tinnitus sucks, but my hyperacusis is horrible.

 

[Muggumbo]

It looks like Cilcare licensed Paliroden and Xaliproden.

The present invention relates to 4-phenyl-tetrahydropyridine derivatives for use in the treatment of hearing diseases, in particular in the treatment of unilateral or bilateral sensorineural hearing loss and/or of cochlear synaptopathy optionally combined with tinnitus. The present invention also relates to a pharmaceutical composition allowing a trans-tympanic administration of 4-phenyl-tetrahydropyridine derivatives and to said pharmaceutical composition for use in the treatment of hearing diseases, in particular in the treatment of unilateral or bilateral sensorineural hearing loss and/or of cochlear synaptopathy optionally combined with tinnitus.

→ 4-phenyl-tetrahydropyridine derivatives for treating hearing diseases

 

[Muggumbo]

I did reach out to Cilcare about clinical trials for tinnitus. They did not provide much new information, but here is their response:

Thank you for reaching out to us. We are currently focusing on hidden hearing loss (cochlear synaptopathy) and tinnitus.

We expect the clinical trial with compound CIL001 to begin towards the end of 2025. We are planning to establish investigational clinical centers in the UK, France, and Germany.

I don't have any precisions on inclusion criteria (such as noise-induced tinnitus) but can keep your contact detail on file, allowing us to promptly notify you when the trial officially launches, and the recruitment period begins (if you are interested in potentially participating in the trial).

Please respond to this email if you would prefer us not to keep your contact details.

Should you have any questions or require further information, please do not hesitate to reach out to us.

If you live in any of these areas, it may not be a bad idea to contact them and get your name on file for any clinical trials.

 

[d'Wooluf]

Imagine going from hearing loss and tinnitus on one end of the scale to not being able to sleep because of the crying baby three doors down the street on the other.

Treating cochlear synaptopathy wouldn't make sounds any louder. Just clearer.

 

[Joeseph Stope]

Treating cochlear synaptopathy wouldn't make sounds any louder. Just clearer.

That reminds me somewhat of the "speech-in-noise test" that the ENT researchers use. Or maybe I'm on the wrong track.

FYI, I use two things for sleeping, etc.: an ordinary FM radio with a mellow sound and a sound machine that can play water trickling, waves, wind, rain, a fan, and white noise. In the early morning, when I turn on the news, turning off the sound machine makes things clearer. So, I have mild optimism that they may be onto something that helps somewhat.

 

[Fields]

Back in June, Cilcare and Shionogi announced an exclusive Option Agreement for innovative hearing disorder treatment. Under the terms of the agreement:

• Shionogi will receive an exclusive option to license global rights to CIL001 and/or CIL003.
• Cilcare will receive an upfront payment of €15 million.
• Cilcare is eligible to receive up to €400 million in milestone payments upon successful development and commercialization of the drug candidates.
• Shionogi will decide whether to exercise the option right based on the results of the Phase 2a studies of CIL001 and preclinical study data of CIL003, both to be conducted by Cilcare.

→ Cilcare and Shionogi announce exclusive Option Agreement for innovative hearing disorder treatment

 

[ColinUK]

Does anyone know how Cilcare's CIL001 differs from Otonomy's research? It seems to be the same molecule that Otonomy tested.

 

[gameover]

Does anyone know how Cilcare's CIL001 differs from Otonomy's research? It seems to be the same molecule that Otonomy tested.

Completely different, it seems. Xaliproden here vs. BDNF for Otonomy.

 

[Muggumbo]

I think this is one of the most promising treatments for tinnitus caused by hearing loss or acoustic trauma. It's also nice to see that tinnitus is their key focus compared to these other restorative approaches.

 

[Nick47]

Completely different, it seems. Xaliproden here vs. BDNF for Otonomy.

This is a 5-HT1A agonist.

 

[gameover]

I think this is one of the most promising treatments for tinnitus caused by hearing loss or acoustic trauma. It's also nice to see that tinnitus is their key focus compared to these other restorative approaches.

It remains to be seen, but I am glad they are trying.

This is a 5-HT1A agonist.

It seems that this is supposed to increase BDNF production.

 

[ringingfeet]

If you live in any of these areas, it may not be a bad idea to contact them and get your name on file for any clinical trials.

Thank you for sharing. I will give it a shot. As someone from the Netherlands, I might be able to participate.

 

[Fields]

I forgot to mention it in my previous post, but Cilcare was also awarded €4.2 million by the French government.

It'll be interesting to see where specifically they'll set up shop for their clinical trials in 2025 (if all goes well). Depending on the distance and format, I might try to apply.

 

[Joeseph Stope]

This is a 5-HT1A agonist.

Correct me here; my memory is not 100% (and never was). But I seem to recall noting that Otonomy was a pan-European conglomerate of researchers. They were experimenting with their molecule at the same time as Frequency Therapeutics was stealing the show in a wave of optimism -- some might say a wave of exuberance. And then (or maybe because of this), Otonomy threw in the towel, saying they had found nothing. Correct me if I've got it wrong.

 

[annV]

Correct me here; my memory is not 100% (and never was). But I seem to recall noting that Otonomy was a pan-European conglomerate of researchers. They were experimenting with their molecule at the same time as Frequency Therapeutics was stealing the show in a wave of optimism -- some might say a wave of exuberance. And then (or maybe because of this), Otonomy threw in the towel, saying they had found nothing. Correct me if I've got it wrong.

You got it completely wrong.

Otonomy was also 100% US-based, and their clinical trials failed multiple times, after which they were forced to throw in the towel. They did no such thing because of Frequency Therapeutics.

 

[Nick47]

Correct me here; my memory is not 100% (and never was). But I seem to recall noting that Otonomy was a pan-European conglomerate of researchers.

Otonomy was USA-based but sponsored some European clinical trial sites for the Phase 2 OTO-313 trial. Sheffield University was one of those sites.

 

[d'Wooluf]

But I seem to recall noting that Otonomy was a pan-European conglomerate of researchers.

This is the one you're thinking of.

 

[Joeseph Stope]

This is the one you're thinking of.

Spot on! It went under the name of Regain... or, in the link above, Regain Consortium.

 

[tomytl]

Some news:

Cilcare is proud to announce that its breakthrough compound, CIL001, has been named the winner in the Therapeutics category at the 5th Annual Hearing Technology Innovator Awards™, hosted by Hearing Health & Technology Matters.

This prestigious recognition celebrates the innovative potential of CIL001, a first-in-class drug candidate designed to treat cochlear synaptopathy, a leading cause of age-related hearing loss, often referred to as "hidden hearing loss." This condition affects millions worldwide and is characterized by difficulty hearing in noisy environments—an issue for which there is currently no approved treatment.

CIL001 is set to enter Phase 2 clinical trials in 2025, following promising preclinical results that demonstrate its ability to address cochlear synaptopathy. With an innovative long-lasting formulation, CIL001 will be administered via a single transtympanic injection, offering a transformative approach to hearing loss treatment.

This recognition highlights CILcare's unwavering dedication to advancing therapies for hearing disorders, reinforcing the company's position as a leader in hearing healthcare innovation.

We extend our heartfelt thanks to the Hearing Technology Innovator Awards™ organizers, the judging panel, and all the fellow innovators who continue to push the boundaries of hearing technology.

→ Cilcare wins prestigious Hearing Technology Innovator Award for CIL001

 

[Fields]

Cilcare is attending the World Congress of Audiology in Paris on September 19-22. For anyone interested, you'll find them at booth #43.

They're also attending the Inner Ear Biology Workshop in Warsaw this month.

I posted this in a different thread. Did anyone happen to attend either of these?