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Hearing Loss Treatment Report

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Targeting the NLRP3 inflammasome in cochlear macrophages protects against hearing loss

September 14, 2024

https://jneuroinflammation.biomedcentral.com/articles/10.1186/s12974-024-03212-6

New successful, expanded trial of groundbreaking therapy for genetic deafness suggests it may be available relatively soon

June 5, 2024

https://news.harvard.edu/gazette/story/2024/06/growing-success-in-new-gene-therapy-for-inherited-deafness/

Delix Therapeutics Awarded Grant from the U.S. Department of Defense to Advance Neuroplastogen for Hearing Loss

June 4, 2024

https://www.biospace.com/article/releases/delix-therapeutics-awarded-grant-from-the-u-s-department-of-defense-to-advance-neuroplastogen-for-hearing-loss/

A novel cell-free therapy using exosomes in the inner ear regeneration

April 18, 2024

https://www.sciencedirect.com/science/article/abs/pii/S0040816624000740

Unveiling the Role of Oxidative Stress in Cochlear Hair Cell Death: Prospective Phytochemical Therapeutics against Sensorineural Hearing Loss

April 12, 2024

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11050722/

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

March 5, 2024

First details on NS101, a 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 situation, and it is not limited to the “rescue therapy” category of treatment.

From the official clinical trial record (NCT06249919):

“NS101 is an anti FAM19A5 antibody expected to play as a synapse organizer and reversing synapse dysfunction in various neurological diseases.”

What else do we know about NS101—and its “regenerative” potential?

NS101 is an investigational new treatment that promotes nerve synapses and nerve regeneration. It’s being developed by Neuracle Science Co., Ltd., in collaboration with Samsung and Korean University. This broad applicability to nerve synapses and regeneration means that NS101 is also being researched to help with degenerative neurological diseases such as Alzheimer’s disease, ALS, and acute spinal cord injury. This means that NS101 may also help with other synaptopathies as well as different kinds of sensorineural hearing loss (not just the sudden sensorineural hearing loss being studied in this particular trial).

This is also supported by clues from the official trial record—note the provided keywords:

NS101 hearing loss indications trial record list
Specific keywords provided by Neuracle Science, relating to study and beyond “sudden” hearing loss.

Last year, on January 26, 2023, the company shared a press release outlining positive results of its first-in-human phase 1 clinical trial of NS101. That trial showed that the treatment had a good safety profile and “robust FAM19A5 target engagement.”

“Neuracle Science (CEO: Dr. Jae Young Seong) announced top-line results from the Phase 1 study of NS101, an investigational monoclonal antibody for the treatment of neurological diseases. NS101 binds to and neutralizes FAM19A5/TAFA5, a potential target for synaptopathy.”

At that time, Neuracle Science also shared that they planned “to initiate further clinical trials with an undisclosed indication…” Based on this phase 1/2 trial development, that undisclosed indication mentioned last year appears to have been hearing loss (plus tinnitus—but more about that later).

The Neuracle Science company website also has some more information, though its website has not yet been updated to cover the hearing loss indication(s). Note: This is not uncommon for small/private biotech companies, as they are usually too busy focusing on the research to update their pipeline snapshot. The company might post an update soon — hopefully one with a deeper dive into the mechanism of NS101 for various forms of sensorineural hearing loss.

The website has not yet been update to include the sensorineural hearing loss research angle.

http://www.neuracles.com/?version=135&spkey=5b3a3e4874f80210e3b655253439c7e702c29894&module=true&PageAccess=main/pipeline#sec01

Quick background on Neuracle Science, the company behind NS101:

According to last year’s press release, “Neuracle Science is a clinical-stage biotech company specializing in the development of new drugs for the treatment of neurological diseases.”

Here is some additional information about Neuracle Science:

Neuracle Science logo
Logo as it appears on the company website, neuracles.com.

http://www.neuracles.com/?version=135&spkey=5b3a3e4874f80210e3b655253439c7e702c29894&module=true&PageAccess=main/neuracle

What type of drug is NS101?

  • IV infusion
  • Doses = 15 mg/kg or 30 mg/kg
  • Frequency = Every second week over the course of 12 weeks
  • Participants will be followed for up to 20 weeks

In addition to testing for safety and tolerability, this study will look at whether NS101 is effective in improving hearing in people with sudden sensorineural hearing loss who have not benefited from treatment with oral steroids. This clinical trial is set up to be placebo-controlled and double-blinded.

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)

Looking further ahead, the anticipated completion date for the study is June 19, 2025.

Here is the link to the official study record for A Phase 1b/2a, Double-blinded, Placebo-controlled, Multiple Doses, 2 Step-up Study Evaluating the Safety, Tolerability, PK/PD and Efficacy of Systemic NS101 in Healthy Volunteers and SSNHL Patients—last updated on February 8, 2024:

https://clinicaltrials.gov/study/NCT06249919

How to get email updates on the development of NS101

If you want updates on NS101 from Neuracle Science — including the progress of this new clinical trial — sign up for the Hearing Loss Treatment Report email newsletter.

* indicates required

It’s free, your information is kept private, and you can unsubscribe at any time with a single click. As a subscriber, you get early access to “first look” updates like this one — before they are added to the front page of this website (or anywhere else).

Expect between 1-2 emails per week… but only if something interesting and treatment-related is happening.

References

https://classic.clinicaltrials.gov/ct2/show/NCT06249919

https://www.linkedin.com/feed/update/urn:li:activity:7024192632750829569/?updateEntityUrn=urn%3Ali%3Afs_feedUpdate%3A%28V2%2Curn%3Ali%3Aactivity%3A7024192632750829569%29

http://www.neuracles.com/?version=135&spkey=5b3a3e4874f80210e3b655253439c7e702c29894&module=true&PageAccess=main/neuracle

http://www.neuracles.com/?version=135&spkey=5b3a3e4874f80210e3b655253439c7e702c29894&module=true&PageAccess=main/pipeline#sec01

AAV-mediated Gpm6b expression supports hair cell reprogramming

February 24, 2024

https://onlinelibrary.wiley.com/doi/10.1111/cpr.13620

A novel pyridoindole (AC102) improves the recovery of residual hearing after a single application [Preprint]

February 19, 2024

https://www.biorxiv.org/content/10.1101/2024.02.14.580226v1

Cochlear zinc signaling dysregulation is associated with noise-induced hearing loss, and zinc chelation enhances cochlear recovery

February 14, 2024

https://www.pnas.org/doi/10.1073/pnas.2310561121

Scientists discover biological mechanism of hearing loss caused by loud noise, and find a way to prevent it

February 12, 2024

https://medicalxpress.com/news/2024-02-scientists-biological-mechanism-loss-loud.html

Current advances in biomaterials for inner ear cell regeneration

January 12, 2024

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10811200/

AudioCure Pharma Awarded for Therapeutic Small Molecule for Hearing Loss

December 7, 2023

https://hearingreview.com/inside-hearing/industry-news/audiocure-pharma-awarded-for-therapeutic-small-molecule-for-hearing-loss

Development of Chinese herbal medicine for sensorineural hearing loss

November 4, 2023

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10840432/

Harvard to evaluate whether two drugs approved by FDA can help regenerate the neural synapses lost between the auditory nerve and sensory cells and regenerate inner-ear synapses lost to noise exposure

July 25, 2023

https://oto.hms.harvard.edu/news/dr-zheng-yi-chen-named-principal-investigator-hearing-restoration-research-program-grant

Boston breakthroughs in gene and drug therapy routes to hearing loss solution

June 15, 2023

https://www.audiology-worldnews.com/research/4820-boston-breakthroughs-in-gene-and-drug-therapy-routes-to-hearing-loss-solution

Drug-Like Molecules Regenerate Hair Cell-Like Cells in Adult Mice

April 20, 2023

https://hearinghealthfoundation.org/blogs/drug-like-molecules-regenerate-hair-cell-like-cells-in-adult-mice

Scientists Regenerate Hair Cells that Enable Hearing

April 19, 2023

Hippo-mediated control of growth and regeneration in the inner ear sensory organs

February 1, 2023

https://reporter.nih.gov/search/ddHB5clCeU2ogGyLiewqlw/project-details/10771262

The effects of cochlear pericytes and pericyte-related vascular pathology on hearing function

February 14, 2020

https://reporter.nih.gov/search/ddHB5clCeU2ogGyLiewqlw/project-details/10763809

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