SPI-1005 for Hearing Loss

Overseen By Jonathan Kil, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sound Pharmaceuticals, Incorporated

Must not be taking: Chemotherapy, Aminoglycosides, Loop diuretics

Disqualifiers: Pregnancy, Breastfeeding, Other studies, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the experimental drug SPI-1005 is safe and effective for adults receiving a cochlear implant. Researchers seek to assess whether SPI-1005 can prevent or treat issues such as hearing loss, difficulty recognizing words, and dizziness following the implant. Participants will take either SPI-1005 or a placebo for six months, beginning two days before their cochlear implant surgery. Adults with severe hearing loss scheduled for a specific type of cochlear implant in one ear may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in hearing loss treatment.

Do I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used certain IV ototoxic medications (harmful to the ear) like some chemotherapy drugs or specific antibiotics within 60 days before joining the study.

Is there any evidence suggesting that SPI-1005 is safe for adults receiving a cochlear implant?

Research has shown that SPI-1005 was safe in earlier studies. Participants in these trials, who took SPI-1005 containing ebselen, tolerated a dose of 400 mg twice a day well. The studies included individuals with conditions such as Meniere's disease and noise-induced hearing loss. SPI-1005 not only helped with these conditions but also did not cause any serious safety issues, suggesting the drug is generally safe. However, like any treatment, some side effects may occur. It is important to consult a healthcare professional about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hearing loss that often involve hearing aids or cochlear implants, SPI-1005 offers a novel approach by using ebselen, a unique active ingredient. Ebselen acts as an antioxidant and mimics glutathione peroxidase, an enzyme that protects cells from damage. Researchers are excited because this mechanism targets the underlying oxidative stress in the ear, potentially offering a way to protect and preserve hearing rather than simply amplifying sound. This could represent a significant advancement in treating hearing loss at its source.

What evidence suggests that SPI-1005 might be an effective treatment for hearing loss?

Studies have shown that SPI-1005 can help treat certain types of hearing loss. For example, research indicates it has benefited people with Meniere's disease, a condition affecting hearing and balance. In these studies, SPI-1005 improved hearing and reduced symptoms like ringing in the ears (tinnitus) and dizziness (vertigo). It protects the inner ear from damage. This trial will test SPI-1005 to determine if it can help people who receive cochlear implants, which can sometimes cause hearing loss or ringing in the ears. Early results suggest it might be a promising option for these patients. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

Adults with severe to profound sensorineural hearing loss, scheduled for a cochlear implant (FLEX26 or greater), can join this trial. They must be able to give informed consent and perform all required tests. Participants should meet specific hearing loss measurements and agree to reproductive requirements.

Inclusion Criteria

I have severe hearing loss in both ears and am scheduled for a MED-EL cochlear implant.

My hearing loss is between 40 and 70 dB in low tones.

I am willing to give consent and follow all study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SPI-1005 or placebo for 6 months, starting 2 days before cochlear implant surgery

6 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• SPI-1005

Trial Overview The trial is testing SPI-1005's safety and effectiveness in adults getting cochlear implants compared to a placebo. It will assess the drug's impact on hearing, word recognition, speech discrimination, tinnitus, and vertigo over six months with five clinic visits.

How Is the Trial Designed?

Group I: SPI-1005 400 mg twice daily (BID) Experimental Treatment 1 Intervention

Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days

Group II: Placebo Placebo Group 1 Intervention

Oral administration of matching placebo BID for 180 days

Who Is Running the Clinical Trial?

Sound Pharmaceuticals, Incorporated

Lead Sponsor

Trials

14

Recruited

1,300+

Med-El Corporation

Industry Sponsor

Trials

27

Recruited

2,100+

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 ... SPI-1005 is being developed for several neurotologic indications including noise-induced hearing loss and two types of ototoxicity (hearing loss ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04677972

SPI-1005 for the Treatment of Meniere's Disease Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment. At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33678494/

Development of ebselen for the treatment of sensorineural ... Multiple phase 2 clinical trials have demonstrated the safety and efficacy of SPI-1005 treatment in Meniere's disease and acute noise-induced ...

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

SPI-1005 A Novel Investigational Drug For The Treatment ... Data from the Phase 2 study ... These otoprotective findings suggest that SPI-1005 maybe valuable treating in patients with sensorineural hearing loss.

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

Development of ebselen for the treatment of sensorineural ... Multiple phase 2 clinical trials have demonstrated the safety and efficacy of SPI-1005 treatment in Meniere's disease and acute noise-induced hearing loss. SPI- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28716314/

a randomised, double-blind, placebo-controlled, phase 2 trial Interpretation: Treatment with ebselen was safe and effective at a dose of 400 mg twice daily in preventing a noise-induced TTS. These data lend ...

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

SPI-1005 for the Treatment of Meniere's Disease (Open ... Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 ...