SPI-1005 for Noise-Induced Hearing Loss

(PANIHL Trial)

Not currently recruiting at 4 trial locations

Overseen By Jonathan Kil, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Sound Pharmaceuticals, Incorporated

Must not be taking: Ototoxic medications, Cytochrome P450

Disqualifiers: Autoimmune ear disease, Ear surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral drug, SPI-1005, which may prevent hearing loss from loud noises. The researchers aim to determine if the drug can reduce hearing damage in individuals who have already experienced noise-induced hearing loss (NIHL) and are at risk for further damage. Participants will receive either the drug or a placebo and then be exposed to noise to assess the drug's effectiveness. Ideal participants are those who have previously experienced hearing issues from noise, whether from work or recreational activities. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot use ototoxic medications (drugs that can harm the ear) within 60 days before the study, and you should avoid drugs that strongly affect liver enzymes within 30 days before the study.

Is there any evidence suggesting that SPI-1005 is likely to be safe for humans?

Research has shown that SPI-1005 has been tested for safety in people with Meniere's Disease, which affects the inner ear. In these studies, participants took the drug for up to 21 days, and it was safe and well-tolerated. Another study found that taking SPI-1005 for 6 to 12 months also supported its safety. Additionally, SPI-1005 demonstrated positive safety results in several other clinical trials. These findings suggest that SPI-1005 is generally well-tolerated, with no major safety concerns reported in these studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SPI-1005 for preventing acute noise-induced hearing loss because it offers a unique approach compared to standard treatments. While most current options focus on minimizing exposure or using protective devices, SPI-1005 contains ebselen, a compound that acts as an anti-inflammatory and antioxidant by mimicking the enzyme glutathione peroxidase. This mechanism helps protect the inner ear cells from damage caused by loud noises. Unlike passive protection methods, SPI-1005 actively targets the biochemical pathways involved in hearing loss, providing a potentially groundbreaking way to prevent damage before it occurs.

What evidence suggests that SPI-1005 could be effective for reducing acute NIHL?

Research has shown that SPI-1005 might help treat hearing loss. In earlier studies, people with Meniere's disease experienced better hearing and clearer speech understanding after using SPI-1005. Many patients noticed improved hearing, especially with low-pitched sounds. In this trial, participants will receive either SPI-1005 or a placebo. Previous studies demonstrated that SPI-1005 outperformed a placebo in some cases. These results suggest that SPI-1005 might also help with hearing loss caused by loud noise, based on its benefits in other hearing conditions. ^{1 4 6 7 8}

Who Is on the Research Team?

Jonathan Kil, MD

Principal Investigator

SOUND PHARMACEUTICALS, INC.

Are You a Good Fit for This Trial?

Inclusion Criteria

History of either recreational and/or occupational exposure to noise

Voluntarily consent to participate in the study

Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL

1 week

Daily dosing

Calibrated Sound Challenge (CSC)

Participants are exposed to a calibrated sound challenge to induce a slight acute NIHL

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up hearing tests

1 week

Post-CSC hearing tests

What Are the Treatments Tested in This Trial?

Interventions

• SPI-1005

How Is the Trial Designed?

Group I: SPI-1005 400 mg Active Control 1 Intervention

400 mg SPI-1005, capsule, bid, po, x7d

Group II: SPI-1005 200 mg Active Control 1 Intervention

200 mg SPI-1005, capsule, bid, po, x7d

Group III: Placebo Placebo Group 1 Intervention

0 mg SPI-1005, capsule, bid, po, x7d

Who Is Running the Clinical Trial?

Sound Pharmaceuticals, Incorporated

Lead Sponsor

Trials

14

Recruited

1,300+

Citations

1. soundpharma.com soundpharma.com/sound-pharma-announces-positive-phase-3-results-for-the-treatment-of-menieres-disease-with-spi-1005/

Sound Pharma Announces Positive Phase 3 Results for ... On day 84, the SPI-1005 group showed a significant rate of WIN improvement of 54.4% over placebo (42.1% vs. 27.1%, p=0.0336). During OLE, ...

2. soundpharma.com soundpharma.com/wp-content/uploads/2018/11/2018-ARO-151.pdf

SPI-1005 A Novel Investigational Drug For The Treatment ... SPI-1005 treated subjects (52%) showed clinically relevant improvements (>10 dB from baseline) in low frequency hearing (. 25, . 5 or 1 kHz), the frequencies ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03325790

SPI-1005 for the Treatment of Patients With Meniere's ... This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in ...

4. pharmacytimes.com pharmacytimes.com/view/phase-3-data-offer-hope-to-patients-with-meniere-disease

Phase 3 Data Offer Hope to Patients With Meniere Disease SPI-1005 demonstrated significant efficacy in improving hearing loss and speech discrimination in Meniere disease patients during a phase 3 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378595521000435

Development of ebselen for the treatment of sensorineural ... This review will summarize the published and presented data from five completed SPI-1005 RCTs involving adult patients with acquired hearing loss and tinnitus.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04677972

SPI-1005 for the Treatment of Meniere's Disease Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06859788

SPI-1005 for the Treatment of Meniere's Disease (Open ... Study Overview. Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or ...

8. soundpharma.com soundpharma.com/sound-pharma-to-present-at-upcoming-life-sciences-industry-conferences/

Sound Pharma to Present at Upcoming Life Sciences ... SPI-1005 has also achieved favorable safety and efficacy results in five different RCTs involving MD, acute noise-induced hearing loss, and ...