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

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):

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

 

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

 

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