According to a news wire from Sound Pharmaceuticals, the biotechnology company has completed patient enrollment for its Phase 2b clinical trial involving Meniere’s disease.
About Meniere’s Disease
Meniere’s disease (MD) is a disorder of the inner ear. It’s often characterized by intermittent spells of dizziness, hearing loss, or tinnitus. In most cases, it affects only one ear.
Although it is generally believed that an excess of fluid in the inner ear is the root of the symptoms of MD, researchers are not yet certain what causes the fluid buildup. The current theory is that MD arises from a confluence of contributing factors, including but not limited to poor fluid drainage, abnormal immune response, viral infection, or even genetic predisposition.
MD symptoms typically begin in early-to-middle adulthood. As people with Meniere’s disease age, their symptoms can worsen in turn. Hearing loss and tinnitus can grow to be especially bad when patients reach their 50s, 60s, and 70s.
Currently, there is no FDA-approved treatment for Meniere’s disease. The condition has historically been “controlled” with low sodium diets, thiazide diuretics, and steroids. This method of management, however, has been largely ineffective at providing MD patients meaningful relief.
SPI-1005 is Sound Pharmaceutical’s experimental drug that supposedly mimics and stimulates activity in a certain anti-oxidizing enzyme called glutathione peroxidase. Sound was convinced by earlier trials that SPI-1005 showed strong promise in preventing and treating hearing loss rooted in either noise damage or Meniere’s disease.
The phase 2b trial will involve 149 individuals with active Meniere’s disease. It will be a randomized, double-blind, placebo-controlled trial conducted in numerous sites across the country. The phase 2b trial will hope to expound on the safety findings of SPI-1005’s phase 1 clinical study, which merely determined that SPI-1005 was safe and well-tolerated in humans in the dosage it will be administered.
The phase 2 trial will also hope to prove a more important aspect of SPI-1005’s pharmacology – whether or not it actually works. Sound Pharmaceutical reported some results at the end of the placebo-controlled phase 1 study that suggested that SPI-1005 had some ability to improve both auditory and vestibular symptoms of Meniere’s disease. However, the phase 1 trial involved only 40 subjects – and the majority of experimental drugs pass this stage of development. Many more patients will have to be evaluated in the phase 2b study before Sound can start to make any robust claims of efficacy in SPI-1005.
The most we can say now definitively is that SPI-1005 isn’t harmful to humans in the doses it will be administered. In the coming months and years, Sound Pharmaceutical will be collecting detailed data on the 149 subjects of the phase 2b trial. If SPI-1005 is able to replicate the encouraging data collected in the phase 1 study, it could start to be considered a real candidate for eventual FDA approval.
Although they are the earliest stage in clinical testing, phase 1 trials can be some of the most dangerous to participate in. Do you think the results Sound encountered in the phase 1 study show promise for the phase 2b follow-up? Why or why not? Share your thoughts with Patient Worthy!