Sensorion’s Phase 1/2 Audiogene trial of the gene therapy SENS-501 for infants and toddlers with OTOF-related congenital deafness shows promising early safety and hearing improvement data, particularly in one patient, with a higher dose cohort now underway.
Sensorion and Sonova announced that they have signed a multi-year strategic collaboration with the aim of introducing genetic analysis to the routine diagnosis of progressive hearing loss in adults, thereby opening the way for “improved care through a combination of advanced therapeutic interventions and traditional hearing aids.”
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 aim of this project is to develop a specific gene therapy program aimed at correcting an inherited monogenic form of deafness caused by a mutation in the gene encoding for the Otoferlin protein (DNBF9).
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The aim of this project is to develop a specific gene therapy program aimed at correcting an inherited monogenic form of deafness caused by a mutation in the gene encoding for the Otoferlin protein (DNBF9).
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Sensorion and Institut Pasteur have leveraged the last six months to reach a partnership framework agreement. This agreement provides for, after completion of a research program, an exclusive option to obtain licenses.
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UConn otolaryngologist Kourosh Parham and his colleagues report in “Hearing Research” that levels of prestin, a protein found only in cells in the inner ear, rise sharply when those cells are damaged and start to die.
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The company reports that Seliforant, in contrast to Meclizine, has no negative CNS side effects such as sedation, impairment of memory, and cognitive performance.
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The paper, published in the peer-reviewed monthly journal “Hearing Research,” found that the outer-hair-cell-specific protein prestin, in circulation, may act as a biomarker for sensory hair cell damage and death.
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Sensorion announced a letter of intent with Pasteur Institute in Paris to exclusively negotiate a framework agreement to obtain the exclusive licenses to develop and commercialize gene therapy product candidates for restoration, treatment, and prevention of hearing loss disorders. They will collaborate on several lead programs to correct monogenic forms of hereditary hearing loss including, among others, the Usher syndrome type 1 and otoferlin deficiency, according to the announcement.
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Seliforant (formerly SENS-111) is currently being studied in an ongoing Phase 2 trial for the treatment of acute unilateral vestibulopathy, a debilitating disease of the inner ear. Its maker, Sensorion, has announced the publication of data in the ‘British Journal of Clinical Pharmacology’ from a Phase 1 study evaluating the safety, tolerability, pharmacokinetics of the drug in healthy subjects. More data are expected at the end of 2018.
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This half-day event follows the Food and Drug Administration’s (FDA) model for externally-led Patient Focused Drug Development meetings and serves to inform the agency’s regulatory decision-making in pediatric oncology.
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The randomized, double-blind, placebo-controlled Phase 2 study will be conducted across 50 sites in Europe, the US, Canada, Israel, and Turkey, and enroll approximately 260 patients.
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By comparing the effects of seliforant to meclizine, a drug with known anticholinergic side effects, and placebo, the SENS-111-202 study aims to confirm the absence of anticholinergic effects such as sedation and memory loss in patients receiving seliforant.
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Data from the presented studies showed that SENS-401 protected inner ear function and enhanced sensory hair cell survival in preclinical models of acoustic trauma and, separately, cisplatin infusion.
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Petit presently serves concurrently as professor at College de France, chair of genetics and cellular physiology, professor at Institut Pasteur (Paris), and head of the Laboratory of Genetics and Physiology of Hearing of the Pasteur Institute.
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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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