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 a poster presentation at the 2019 Annual Meeting of the Society for Neuroscience (SFN 2019) held in Chicago (IL, USA), from the 19th to the 23rd of October, 2019.
In the session “Discovery and Treatment Studies in Auditory and Visual Preclinical Neuroscience”, the poster entitled “Inner ear exposure of SENS-401 is not altered by severe acoustic trauma in a rat model” presented studies that investigated the potential effects of animal model specificity on systemic and local SENS-401 exposure using an acoustic trauma model in Wistar rats.
It has previously been demonstrated in animal models that exposure to noise trauma or ototoxic drugs can enhance the local exposure of macromolecular tracer agents in the inner ear after systemic administration. These tracers agents only achieve low local exposure in naïve animals suggesting a permeabilization of the blood labyrinth barrier in injury models.
To determine if the preclinical hearing loss model would influence the pharmacokinetics (PK) and local exposure of SENS-401, a therapeutically relevant dose was administered to rats after exposure to severe acoustic trauma. SENS-401 concentrations in blood plasma and inner ear were subsequently compared to those of rats having undergone a sham noise exposure. No differences in blood plasma content or inner exposure levels of SENS-401 were found between the two groups of animals, demonstrating that noise trauma did not affect PK and local exposure of SENS-401, an otoprotective drug candidate selected specifically due to its ability to achieve high local exposure in the inner ear.
These results support that the use of the acoustic trauma for induction of sudden sensorineural hearing loss (SSNHL) did not result in animal model specific effects on local exposure of SENS-401, but permits a confident integration of preclinical efficacy, pharmacokinetic and safety data without injury model specific dependency. Therefore, these reported findings underscore the utility of preclinical PK/PD and local exposure studies of SENS-401 to support the clinical trial dose selection.
SENS-401, arazasetron besylate, is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment. A small molecule that can be taken orally or via an injection, SENS-401 has received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss, and Orphan Drug Designation from the US FDA for the prevention of platinum-induced ototoxicity in pediatric population. it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).
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. Its 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).
Sensorion has built a unique R&D technology platform to expand its understanding of the physiopathology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates. The Company has also identified biomarkers to improve diagnosis and treatment of these underserved illnesses.
Sensorion is launching in the second half of 2019 two preclinical gene programs aiming at correcting hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin. The Company is uniquely placed through its 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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