SEATTLE, Sept. 18, 2019 /PRNewswire/ — Sound Pharmaceuticals is pleased to announce that the FDA’s Division of Neurology Products has granted its request for Fast Track Designation (FTD) involving SPI-1005 in the treatment of Meniere’s Disease (MD). FTD applies to serious conditions where the potential to address unmet medical need has been demonstrated. SPI’s clinical data from two completed multi-center, randomized, placebo-controlled studies (Phase 1b and Phase 2bclinical trials) were the basis for the designation, and showed that oral delivery of SPI-1005 for 21 or 28 days improved tinnitus and restored sensorineural hearing loss in patients affected by MD. FTD allows for the expedited development of SPI-1005 involving more frequent meetings with the FDA, rolling reviews, and the potential for priority review at the filing of New Drug Application (NDA). SPI has an End-of-Phase 2 Meeting scheduled with the FDA to discuss the pivotal Phase 3 study design and additional data required for NDA filing. “This is a major regulatory milestone for our most advanced clinical program to date,” said Jonathan Kil, MD, Co-Founder and CEO.
SPI-1005 is an investigational new 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 tinnitus, and two types of ototoxicity (hearing loss, tinnitus, dizziness or vertigo): due to aminoglycoside antibiotics (such as tobramycin) and due to platinum-based chemotherapy. In earlier clinical trials, SPI-1005 demonstrated strong proof-of-concept data supporting the potential treatment in preventing and treating noise induced hearing loss and Meniere’s disease.
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