MONTPELLIER, France, June 07, 2022–(BUSINESS WIRE)–Regulatory news:
Sensorion (FR0012596468 – ALSEN), a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent in the field of hearing loss disorders, today announces the initiation of a proof-of-concept (POC) clinical trial of SENS -401 (Arazasetron) in patients undergoing cochlear implantation has been approved by regulatory authorities in France.
Approval has been granted to initiate a Phase 2a trial with SENS-401 for hearing preservation in patients who, due to moderate to profound hearing loss, are scheduled to undergo cochlear implantation. The trial will be a multicenter, randomized, controlled, open-label trial to assess the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult participants prior to cochlear implantation. Patients will receive SENS-401 for 49 days.
The trial will also assess a number of secondary endpoints, including the change in hearing threshold from baseline to endline in the implanted ear at multiple frequencies. As previously announced, the first patient recruitment is expected by mid-2022.
In early 2021, Sensorion published positive preclinical data demonstrating that the combination of its SENS-401 molecule with a cochlear implant reduced residual hearing loss at a frequency beyond the electrode array. The preservation of “natural” hearing is particularly important in speech recognition. Preclinical studies have been undertaken in collaboration with the world leader in implantable hearing, Cochlear Ltd.
“We are very pleased to have received approval to initiate our clinical trial of SENS-401 for hearing preservation in patients undergoing cochlear implantation,” said Géraldine Honnet, Medical Director of Sensorion. “We have already seen encouraging preclinical data that supports our innovative approach of combining SENS-401 with cochlear implants and we believe this has the potential to produce significant clinical benefits for patients with hearing loss. In collaboration with the world leader in implantable hearing, Cochlear, we look forward to enrolling the first patient by the middle of the year.”
SENS-401 (Arazasetron) is a drug candidate that aims to protect and preserve inner ear tissue from damage that can lead to progressive or sequelae hearing loss. A small molecule that can be taken orally or by injection, SENS-401 has received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss and US FDA Orphan Drug Designation for the prevention of platinum-induced ototoxicity in pediatrics. population. It has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA).
Sensorion is a pioneering clinical-stage biotechnology company specializing 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 modalities for drug candidates. Its portfolio combines both small molecule programs and a preclinical portfolio of inner ear gene therapies.
Its clinical-stage pipeline includes a Phase 2 product: SENS-401 (Arazasetron) which is progressing in a planned proof-of-concept Phase 2 clinical study of SENS-401 in cisplatin-induced ototoxicity (CIO) and, with its partner Cochlear Limited, a study of SENS-401 in patients scheduled for cochlear implantation.
Sensorion has entered into a broad strategic collaboration with the Institut Pasteur focused on the genetics of hearing. It has two gene therapy programs aimed at correcting hereditary monogenic deafness, including deafness caused by a mutation in the gene coding for Otoferlin and deafness linked to the mutation of GJB2 gene to potentially treat significant segments of hearing loss in adults and children. The Company is also working to identify biomarkers to improve the diagnosis of these underserved diseases.
IS IN: FR0012596468
This press release contains certain forward-looking statements regarding Sensorion and its business. These forward-looking statements are based on assumptions that Sensorion believes are reasonable. However, there can be no assurance that these forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2021 Annual Financial Report published on April 28, 2022 and available on our website and as conditions change. economic, financial markets and 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 any or all of these risks could cause Sensorion’s actual results, financial conditions, performance or achievements to differ materially from these forward-looking statements. This press release and the information it contains do not constitute an offer to sell or subscribe, nor a solicitation of an offer to buy or subscribe to Sensorion shares in any country whatsoever. The distribution of this press release in certain countries may violate local laws and regulations. Any recipient of this press release should inform themselves about and comply with any such local restrictions.
See the source version on businesswire.com: https://www.businesswire.com/news/home/20220606005846/en/
Head of Investor Relations & Communication
+ 33 6 72 18 00 22
International media relations
Consilium Strategic Communications
Mary-Jane Elliott/Jessica Hodgson
+ 44 7739 788014
+44 7561 424788