Neuracle Science Initiates Phase 1/2 Clinical Trial of NS101 for the Treatment of Hearing Loss

[Nick47]

New pipeline candidate for sensorineural hearing loss (previously "undisclosed indication"), from Neuracle Science.

A new Phase 1/2 clinical trial of NS101 for the treatment of hearing loss was added to ClinicalTrials.gov on February 8, 2024. The trial, titled A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients, lists a start date of January 19, 2024. The study record and public details only emerged more than a month later, however.

Here is what we know so far:

This new trial is currently recruiting participants and the sponsor, Neuracle Science, plans to enroll a total of 118 participants across 16 locations.

Important point: although the study is evaluating NS101 for SSNHL (sudden sensorineural hearing loss), the testing on healthy volunteers is not without significance. The drug's potential applications extend beyond sudden/acute situations, and it is not limited to the "rescue therapy" category of treatment.

From the official clinical trial record (NCT06249919):

Researchers will be looking for improvements in these outcomes:

• Hearing capacity (via Pure Tone Audiometry, ABR, DPOAE, ECochG)
• Speech discrimination (via SRT, SDS)
• Tinnitus (via THI, VAS)

→ A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients

 

[Muggumbo]

Very exciting. The fact that it actually lists tinnitus is promising.

 

[Street Novelist]

All testing locations in Korea, so the best we'll be able to do is monitor their progress.

 

[LovableGamer]

Have there been any updates? I believe they should have results soon, if they do not already. It seems very promising, so I hope it has been successful.

 

[Nick47]

Have there been any updates? I believe they should have results soon, if they do not already. It seems very promising, so I hope it has been successful.

The trial concludes in June 2025. I believe this is a salvage therapy for those who do not recover hearing with steroids. However, I do not think it is useful beyond the first few weeks after the hearing loss occurs.

 

[LovableGamer]

The trial concludes in June 2025. I believe this is a salvage therapy for those who do not recover hearing with steroids. However, I do not think it is useful beyond the first few weeks after the hearing loss occurs.

But it said the effects could extend beyond the sudden phase and the rescue phase? So most people still may not benefit, since I believe many are already past that point.

 

[LovableGamer]

 

[Gorbeh3]

NS-101 restores synapse function in hearing loss models

Family with sequence similarity 19 member A5 (FAM19A5) is a secretory protein highly expressed in the brain that regulates synapse dynamics through its interaction with leucine-rich repeat-containing 4B (LRRC4B). Noise exposure is one of the most significant causes of synapse loss between inner...

www.bioworld.com

Posted last month. It does not look groundbreaking, but it does seem like some progress.

If someone could use a dummy credit card to access the article and share it, that would be appreciated.