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.