MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:
Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces that promising new data and analysis results from the SENS-401 following cochlear implantation Phase 2a clinical study will be presented at the 17th International Conference on Cochlear Implants and Other Implantable Technologies (CI2024) taking place on July 10-13, 2024, in Vancouver, Canada.
On this occasion, Professor Stephen O’Leary, M.D., Ph.D., will present the results of the Phase 2a clinical trial of SENS-401 in the prevention of residual hearing loss after cochlear implantation, of which he is the principal investigator. The study is developed in collaboration with partner Cochlear Limited, the global leader in implantable hearing devices.
The presentation will take place on Saturday, July 13, 2024, at 9.40am (PDT) at the Vancouver Convention Centre.
Practical details
Presentation by Stephen O’LEARY, M.D., Ph.D.: Early Preservation of Residual Hearing Six Weeks Post Cochlear™ Nucleus® CI622 Implantation and Detection of SENS-401 in Perilymph: Findings from a Phase IIa Clinical Trial Investigating Repeated Oral Administration of SENS-401 in Implant Patients
Address: 1055 Canada Place, Vancouver, British Columbia
In 2017, Sensorion and Cochlear signed a research collaboration agreement on SENS-401, under which Cochlear has an option, exercisable once the data of the complete readout of this study is available, to negotiate with Sensorion the rights for a global license to distribute SENS-401 for applications and uses related to certain implantable devices.
About SENS-401
SENS-401 (Arazasetron), Sensorion’s clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion currently develops SENS-401 in a Phase 2a for the prevention of residual hearing loss in patients scheduled for cochlear implantation and in a Phase 2 clinical trial for the prevention of Cisplatin-Induced Ototoxicity. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population.
About Sensorion
Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates.
It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.
Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022.
www.sensorion.com
Label: SENSORION
ISIN: FR0012596468
Mnemonic: ALSEN
Disclaimer
This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2023 full year report published on March 14, 2024, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.
Contacts
Investor Relations
Noémie Djokovic, Investor Relations and Communication Associate
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Press Relations
Ulysse Communication
Bruno Arabian / 00 00(0)6 87 88 47 26
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Nicolas Entz / 00 33 (0)6 33 67 31 54
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