June 2020 Daily Record-News
Sound Pharmaceuticals announced that the FDA has allowed its pivotal Phase 3 clinical protocol for SPI-1005 in the Treatment of Patients with Meniere's Disease (STOPMD-3). This is the first Phase 3 study of an investigational new drug for the treatment of Meniere's Disease (MD), a neurotologic disease involving hearing loss, tinnitus, and dizziness. To date, there are no FDA approved therapies involving MD, hearing loss, tinnitus, or dizziness. "This is a major development and regulatory achievement for our company and the field of neurotology" said Jonathan Kil, MD, Co-Founder and CEO. SPI's clinical data from two completed multi-centre, randomised, placebo-controlled studies (Phase 1b and Phase 2b clinical trials) showed that oral delivery of SPI-1005 for 21 or 28 days improved sensorineural hearing loss and tinnitus in patients affected by MD. SPI competed an End-of-Phase 2 Meeting with the FDA late last year and will conduct the STOPMD-3 protocol at over 16 US sites.
SPI-1005 is an investigational drug that contains ebselen, a small molecule that is a new chemical entity, or NCE, under FDA classification. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity and represents a novel class of anti-inflammatory. GPx activity is critical to several cell types and tissues in the inner ear, retina, brain, lung and kidney, and is often reduced during exposures to environmental insults. Loss of GPx activity has been shown to result in sensorineural hearing loss in multiple animal models. SPI-1005 is given orally and is being tested in several neurotologic indications including noise induced hearing loss and two types of ototoxicity (hearing loss, tinnitus, dizziness or vertigo): due to aminoglycoside antibiotics (such as tobramycin) and due to platinum-based chemotherapy.