According to a news release from biotechnology company Sound Pharmaceuticals, enrollment has begun in the Phase 3 STOPMD-3 clinical trial. So far, the first patient has been enrolled – with more to come! The trial will be evaluating SPI-1005 for patients with Meniere’s disease. This is a particularly interesting and important trial for two reasons:

• It is the first Phase 3 study evaluating an investigational treatment option for Meniere’s disease.
• The current standards-of-care for Meniere’s disease include vestibular rehab, limiting salt and alcohol, and medications like diuretics or motion sickness medication. SPI-1005 could be the first therapeutic option to address the numerous symptoms of Meniere’s disease, filling an unmet need within this patient population. 

Altogether, 200 individuals will enroll within the Phase 3 study. During the trial, patients will first receive either 400mg SPI-1005 2x daily or a placebo. Next, patients can receive SPI-1005 for a 6-12 month period to evaluate safety and efficacy over time. 

SPI-1005 is an orally administered investigational treatment option which contains ebselen, a New Chemical Entity (NCE) that may have anti-inflammatory properties. Ebselen also helps to induce GPx activity. Since this plays a role in ear, brain, lung, and kidney health – and reduced GPx activity has previously been linked to hearing loss – researchers believe this could be greatly beneficial for those with Meniere’s disease. 

Prior data from Phase 1b and 2b studies found that SPI-1005 helped reduce tinnitus (ringing or buzzing in the ears) and stopped or reduced hearing loss within as fast as 3-4 weeks. 

About Meniere’s Disease

Meniere’s disease is a rare inner-ear disorder which can impact balance and hearing. Scientists are unsure of the exact cause of Meniere’s disease. However, many hypothesize that it results from an abnormal amount of endolymph (a type of fluid) in the inner ear. Other potential causative factors include viral infections, allergies, head trauma, an abnormal immune response, improper fluid drainage, or genetic predisposition. Regardless, this disorder causes severe dizziness (vertigo), ear pressure, pain, tinnitus, and problems with balance. These often occur in “attacks,” which may last for a few minutes or a few hours. Typically, this disorder affects one ear, though it may involve both in later stages.

Meniere’s disease is most common in those between ages 40-60, though it can occur in other groups. Symptoms can include:

• Vertigo
• Hearing loss in the affected ear
• Tinnitus
• A feeling that the ear is full or plugged
• Balance loss
• Nausea and vomiting
• Sweating
• Headaches