MONTPELLIER, FRANCE –Sensorion (FR0012596468 – ALSEN), a pioneering biotechnology company focused on hearing loss disorders, has released further analysis from its Phase 2a clinical trial of SENS-401. The trial aims to preserve residual hearing in adult patients who have undergone cochlear implantation.
The preliminary data, which will be detailed in a webinar led by Professor Yann Nguyen and Sensorion’s management team today, showcases positive efficacy outcomes (event details below).
Positive Prelimary Data for Residual Hearing Preservation
On June 19th, Sensorion announced that in preliminary data from the Phase 2a study, SENS-401 was detected in the perilymph of all 5 adult patients treated with the product. Levels of SENS-401 were considered consistent with potential therapeutic effects after seven days of repeated oral treatment.
The latest analysis reveals that the study also examined secondary endpoints, including changes in hearing threshold at different frequencies. Patients with a baseline pure tone audiometry (PTA) threshold of 80 dB or better at 500 Hz were eligible for the trial.
The analysis indicates that SENS-401-treated patients retained 21 dB of their residual hearing six weeks after cochlear implantation at 500 Hz, compared to the control group. In contrast, the control group experienced a larger loss of 33 dB.
These findings highlight the clinical significance of a 21 dB difference, suggesting that SENS-401 may offer a protective effect against early residual hearing loss following cochlear implantation.
Expert Insights and Potential Impact
Nawal Ouzren, CEO of Sensorion, expressed enthusiasm for the promising preliminary data, highlighting its potential to prevent residual hearing loss in adult patients with hearing disorders. Preserving residual hearing can enhance speech perception and the quality of sound perception against background noise.
“Two weeks ago we demonstrated that SENS-401 crossed the labyrinthine barrier to the cochlea. Today, following further analysis, we have gone much further and have shown SENS-401 potential to preserve early residual hearing six weeks after cochlear implantation. Patients treated with SENS-401 showed improved hearing preservation compared to the patients in the control group, corroborating the otoprotective potential of the molecule. We believe SENS-401 is a ground-breaking therapy with great potential in an area of significant unmet need and we are looking forward to seeing the final results of the study.”
—Géraldine Honnet, M.D., Sensorion’s Chief Medical Officer
Webinar
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
