The company reports that SENS-401 was “safe and well tolerated, however, it did not meet the primary endpoint of 15 dB, a significant improvement in pure tone audiometry (PTA, dB) in the affected ear from baseline in comparison to placebo at the end of the four-week treatment period.”
Honnet is a medical doctor and joins the company from Généthon, where she spent nine years as Chief Medical Officer, overseeing international gene therapy clinical trials in multiple rare diseases.
The company reports that Seliforant, in contrast to Meclizine, has no negative CNS side effects such as sedation, impairment of memory, and cognitive performance.
The laboratory study identified changes in prestin blood levels, an outer hair cell (OHC) protein, in a preclinical model with noise-induced hearing loss.
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The data being presented by Sensorion include results from a study of SENS-401 in preclinical models, designed to determine how long after hearing loss onset SENS-401 could be administered, and results from a study conducted in collaboration with the University of Connecticut (UConn Health) of a circulating blood biomarker for hearing loss.
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SENS-401, R-azasetron besylate, is a drug candidate that aims to protect and preserve inner ear tissue when lesions are present that can cause progressive or sequelar hearing impediments.
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Sensorion will principally use the funds to finance the preclinical combination studies that will evaluate SENS-401’s therapeutic effect on hearing outcomes achieved with Cochlear’s implantable devices.
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The collaboration will evaluate therapeutic approaches using SENS-401—R-azasetron besylate, a drug candidate that aims to protect and preserve inner ear tissue when lesions are present that can cause progressive or sequelar hearing impediments—in combination with cochlear implants.
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The drug is a therapy in development for the treatment of hearing disorders, for the prevention of Platinum-Induced Ototoxicity in pediatric patients.
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