MONTPELLIER, FRANCE — Sensorion, a clinical-stage biotechnology company specializing in hearing loss disorders, has announced promising preliminary results from its Phase 2a clinical trial of SENS-401 for residual hearing preservation following cochlear implantation. The trial evaluated the presence of SENS-401 in the cochlea after oral administration in adult participants with hearing impairment.
The study confirmed the presence of SENS-401 in the cochlea of all patients, indicating its potential for preserving residual hearing. Sensorion will provide further analysis of the study during a webinar on July 5, 2023.
Key Highlights:
- SENS-401 first-in-class drug candidate showed promising preliminary data in POC Phase 2a study to prevent residual hearing loss after cochlear implantation
- Preliminary results demonstrated 100% patients treated with SENS-401 showed presence of SENS-401 in perilymph at therapeutic concentrations, confirming that the oral presentation of SENS-401 passed through the labyrinth barrier to the cochlea
- Sensorion to host a KOL Webinar on July 5, 2023
SENS-401 Phase 2a Trial in Cochlear Implantation
The Phase 2a trial is a multicentric, randomized, controlled, open-label trial that assessed the efficacy of SENS-401 in preserving residual hearing in patients scheduled for cochlear implantation. Patients received SENS-401 for 7 days before the implantation and continued treatment for 42 days. Secondary endpoints included changes in hearing threshold from baseline to the end of the study.
Preliminary results from the trial showed that SENS-401 was present in the perilymph of all five patients at a level compatible with therapeutic efficacy after 7 days. This confirms the molecule’s ability to cross the labyrinth barrier and potentially preserve residual hearing.
Sensorion’s Chief Medical Officer, Géraldine Honnet, expressed confidence in SENS-401 and its potential to provide solutions for individuals with hearing loss disorders. “Presence of SENS-401 in the cochlea in 100% of patients having undergone cochlear implantation surgery confirms our confidence in the potential of our small molecule. These preliminary results support Sensorion’s ambition to provide solutions for people with hearing loss disorders. We will report further data from our Phase 2a study of SENS-401 in association with cochlear implants during our KOL webinar to be held on July 5, 2023.”
Professor Yann Nguyen, an ENT Surgeon at the Hospital Pitié Salpêtrière in Paris, France, praised the preliminary data and its potential clinical benefits for patients undergoing cochlear implantation.
“The SENS-401 preliminary data suggests a compelling clinical profile for patients scheduled for cochlear implantation. These results are very promising, and I look forward to seeing further data of SENS-401, which has the potential to produce clinical benefits to patients suffering from hearing loss.”
–Dr. Yann Nguyen, ENT Surgeon
The webinar, scheduled for July 5, 2023, will feature a presentation by Professor Yann Nguyen, who will discuss the importance of residual hearing preservation and the surgical procedure for perilymph sampling. Sensorion’s management team will also provide additional analysis of the preliminary results during the webinar. The study has been conducted in collaboration with Cochlear Ltd., a global leader in implantable hearing devices.
Those interested in attending the webinar can register through the provided link.
Sensorion’s KOL Webinar Wednesday July 5th, 2023
11am – 12pm ET / 5pm – 6pm CET
To register for the KOL Webinar, please click here
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. In addition, Sensorion expects to evaluate SENS-401 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. OTOF-GT 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.
Source: Sensorion
