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 the initiation of a Proof of Concept (POC) clinical trial of SENS-401 (Arazasetron) in patients scheduled for cochlear implantation has been approved by regulatory authorities in France.
Approval has been granted to launch a Phase 2a trial with SENS-401 for hearing preservation in patients who, due to having moderately severe to profound hearing impairment, are scheduled for cochlear implantation. The trial will be a multicenter, randomized, controlled, open-label trial to evaluate 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 outcome measures, including the change of hearing threshold from baseline to the end of the study in the implanted ear at several frequencies. As previously announced, first patient enrolment is anticipated by mid-2022.
At the beginning of 2021, Sensorion released positive preclinical data demonstrating that the combination of its SENS-401 molecule alongside a cochlear implant helped reduce loss of residual hearing at a frequency located beyond the electrode array. Preservation of ‘natural’ hearing is particularly important in speech recognition. Preclinical studies were undertaken in collaboration with the global 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 scheduled for cochlear implantation,” said Géraldine Honnet, Chief Medical Officer 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 to patients suffering from hearing loss. Collaborating with the global leader in implantable hearing, Cochlear, we look forward to enrolling the first patient by mid-year.”
SENS-401 (Arazasetron) 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 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 modalities for drug candidates. Its portfolio combines both small molecule programs and a preclinical portfolio of inner ear gene therapies.
Its 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, a study of SENS-401 in patients scheduled for cochlear implantation.
Sensorion has entered into a broad strategic collaboration with Institut Pasteur focused on the genetics of hearing. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness including deafness caused by a mutation of the gene encoding for Otoferlin, and hearing loss related to mutation 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.
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 2021 full year financial report published on April 28, 2022, 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.