http://www.news-medical.net/news/20160105/FDA-permits-Sound-Pharmaceuticals-to-start-SPI-1005-clinical-trial-for-treatment-of-Menieres-Disease.aspx FDA permits Sound Pharmaceuticals to start SPI-1005 clinical trial for treatment of Meniere's Disease Sound Pharmaceuticals (SPI) is pleased to announce that it began enrolling a clinical trial to test SPI-1005 in the treatment of Meniere's Disease (MD). MD or idiopathic endolymphatic hydrops is an inner ear disease that involves episodic vertigo, sensorineural hearing loss, and tinnitus. Patients with MD may also complain of aural fullness or pressure. SPI-1005 is an investigational drug that contains an orally available small molecule that mimics and induces Glutathione Peroxidase (GPx) activity. GPx1 activity is diminished after ototoxic insults that cause sensorineural hearing loss and tinnitus. In pre-clinical studies, SPI-1005 has been shown to prevent and treat different types of hearing loss that involve auditory hair cells and neurons. In a recent Phase 2 clinical study, SPI-1005 was shown to prevent sensorineural hearing loss due to noise. According to the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), 600,000 people in the US have MD. This Phase 1b clinical trial will enroll 40 subjects at four centers in the US. This marks the third active IND sponsored by SPI for sensorineural otologic indications. Currently, there are no FDA approved drug treatments for MD, or any other sensorineural disease of the inner ear. "Based on the anti-inflammatory activity of SPI-1005, we hope that it will be of benefit in Meniere's disease," said Jonathan Kil, MD, CEO. SPI is a privately held biopharmaceutical company in Seattle with a focus on developing the first drugs for the prevention and treatment of sensorineural hearing loss and tinnitus. According to the CDC, sensorineural hearing loss is the third largest chronic disease and affects over 31 million adults in the US. Tinnitus, is the abnormal perception of sound, and affects 10-15% of adults according to the AAO-HNS. Vertigo is a type of dizziness that involves a sense of spinning and affects millions of Americans.
Doesn't look as though this investigational drug does more than stop sensorineural hearing loss. Preserving hearing is important, of course. But if vertigo remains uncontrolled, Meniere's disease will continue to be extremely debilitating. --John of Ohio
WOW. That is great. If I still lived in Seattle I would be pounding down their doors to try to be included. ;D
The study page says: This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease
Here is the clinical trial page (study Record Detail) https://clinicaltrials.gov/ct2/show/NCT02603081 Study to Evaluate SPI-1005 in Adults With Meniere's Disease Purpose This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease. read more here https://clinicaltrials.gov/ct2/show/NCT02603081
I did not see how it helps vertigo. Did I miss it? Does anybody know? When will it be available? I did not see that either, but I could have missed both, because I am a bit dizzy today!
Purpose This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.
It sounds promising but I'd rather see something that also takes care of the vertigo. Vertigo is one of the most dipolitating symptom of Menieres as it also affects all of our quality of life. Without that factored in, this is okay but not great.
it says that is has inflammation reducing properties, which they believe may assist in vertigo reduction. I have reached out about the studay and am scheduled to talk with one of the researchers on the 27th. My issue is that none of the results form the sensourial hearing trials seem to be posted only from the rats. Vicki are you seeing results anywhere. I know you are a phenominal researcher.
AFAIK the trial just started, https://clinicaltrials.gov/ct2/show/NCT02603081 First received: November 2, 2015 Last updated: December 10, 2015 Last verified: December 2015 I believe they are still recruiting people.
https://clinicaltrials.gov/ct2/show/results/NCT02603081 No Study Results Posted on ClinicalTrials.gov for this Study About Study Results Reporting on ClinicalTrials.gov Study Status: This study is currently recruiting participants. Estimated Study Completion Date: December 2016 Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure) Study Status: This study is currently recruiting participants. Estimated Study Completion Date: December 2016 Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Thanks for all the information everyone. Loo Hoo when you do talk to the researcher, please post what you find out. I know it goes without saying and I am sure you were going to, but just saying...
What i meant was that i have not found results for the sensourial hearing lost study not the menieres study. that one has not started yet so ofcourse they would not have results.
oh sorry I found the phase 2 trial http://oto.sagepub.com/content/151/1_suppl/P83.4.abstract Efficacy of SPI-1005 for Prevention of Noise-Induced Hearing Loss: Phase 2 Clinical Trial Results Jonathan Kil, MD (presenter) Eric D. Lynch, PhD Scott Griffiths, PhD Edward Lobarinas, PhD Christopher Spankovich, PhD Patrick J. Antonelli, MD, MSc Colleen Le Prell, PhD Abstract Objectives: Determine the safety and efficacy of SPI-1005, a novel oral glutathione peroxidase (GPx) mimic and inducer, in preventing and treating noise-induced hearing loss (NIHL) in adults ranging from slight hearing loss (≤25 dBHL) to normal hearing. Methods: Randomized double blind placebo controlled Phase 2 clinical trial conducted December 2012 through November 2013. A total of 83 subjects at the University of Florida were enrolled and treated with either placebo or SPI-1005 prior to a single iPod sound exposure lasting 4 hours that induced a slight temporary threshold shift (TTS). The incidence (≥10 dBHL), severity (dBHL), and duration (up to 1 week post sound) of the TTS were determined by serial pure tone audiometry. The intervention (200, 400, or 600 mg SPI-1005 twice daily × 4 days) was compared with matching placebo in reducing the TTS. Significance was determined by 2-tailed t tests comparing a specific SPI-1005 treatment group versus placebo. Results: Oral SPI-1005 treatment showed a significant reduction in TTS incidence (60% vs 20%, P < .01), severity (4.2 vs 1.1 dBHL at 4 kHz, P < .01), and duration (24 vs 1.3 hours, P < .01). SPI-1005 treatment was well tolerated with no drug-related adverse events (CBC, Chem20, chest x-ray). Conclusions: SPI-1005 treatment demonstrated clinically relevant reductions in TTS induced by loud sound exposure. Multiday treatment with all SPI-1005 dosages was well tolerated. These data support the continued development of SPI-1005 in noise exposed populations and the GPx mechanism of action in preventing and treating NIHL.