- Clinical data demonstrating lack of sedation or cognitive impairment by SENS-111 (Seliforant)
- Preclinical data on circulating prestin levels in a model of mild noise-induced hearing loss
MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, has contributed two presentations in the scientific poster session at the 2019 Annual Meeting of the American Academy of Otolaryngology, Head and Neck Surgery/Foundation (AAO-HNSF) held in New Orleans LA, the 15-18th of September, 2019.
The first poster is entitled “SENS-111 Maintains Cognitive Functions in Healthy Volunteers in Contrast to Meclizine”. The study has demonstrated that SENS-111 compared to placebo has no sedative effects and consequences on vigilance, cognition and working memory confirmed by both the VigTrack and Pepsy® tests battery. The data is further confirmed by patients’ self-assessed measures on the Stanford Sleepiness Scale (SSS). In contrast, Meclizine 50mg has been demonstrated to negatively impact vigilance and showed sedative effects. The most important and limiting side effect of sedation is counterproductive to normal functioning and the natural recovery process from vertigo occurring via central compensation. The impact of these findings on the long-term recovery from acute vertigo will need to be confirmed in clinical trials.
The presentation “Plasma Prestin and Distortion Product Otoacoustic Emission Correlations after Mild Noise-Induced Hearing Loss” demonstrated a strong correlation between the amplitude loss of Distortion Product OtoAcoustic Emissions (DPOAE) and changes in circulating Prestin levels in an animal model of variable and mild noise-induced hearing loss studied in collaboration with with Dr. Kourosh Parham at UCONN Health.
These results expand the successful collaboration with the group of Dr. Parham on the potential of the inner ear specific protein Prestin as a circulating biomarker, with promising results from a more severe model of noise-induced hearing loss published jointly in the peer-reviewed journal Hearing Research earlier this year (Parham, K et all: Noise-induced trauma produces a temporal pattern of change in blood levels of the outer hair cell biomarker Prestin, Hear Res, 371:98-104, 2019).
Seliforant (formerly SENS-111) is the first representative candidate of the histamine type 4 receptor antagonist class to be tested for the symptomatic treatment of vertigo crises. Displaying a neuromodulation effect of the sensorineural inner ear cell function, Seliforant is a small molecule that can be taken orally or via a standard injection, and is currently in a separate Phase 2 clinical trial, being conducted in the United States, Europe, Israel and South Korea.
Sensorion is a pioneering clinical-stage biopharmaceutical company, which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, vertigo and tinnitus. Our clinical-stage portfolio includes two phase 2 products: Seliforant (SENS-111) under investigation for acute unilateral vestibulopathy and Arazasetron (SENS-401) for sudden sensorineural hearing loss (SSNHL). We have built a unique R&D technology platform to expand our understanding of the physiopathology and etiology of inner ear related diseases enabling us to select the best targets and modalities for drug candidates. We also identify biomarkers to improve diagnosis and treatment of these underserved illnesses. Sensorion is launching in the second half of 2019 two preclinical gene programs aiming to correct hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin. We are uniquely placed through our platforms and pipeline of potential therapeutics to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders; a significant global unmet need in medicine today.
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