Sensorion Achieves Key Milestone in SENS-401 Hearing Preservation Trial

Sensorion, a clinical-stage biotechnology firm renowned for pioneering treatments to combat hearing loss, has achieved a significant milestone in its Phase 2a clinical trial for SENS-401. The trial aimed to ascertain if the drug could be detected in the cochlea at concentrations that might be therapeutically effective after cochlear implantation. The study involved a randomized, controlled, open-label approach and was conducted in collaboration with Cochlear Limited, a leading provider of implantable hearing devices.

The trial focused on the presence of SENS-401 in the perilymph, a fluid within the cochlea, after seven days of twice-daily oral administration. Patients received the drug for a week prior to implantation and continued for an additional 42 days post-operation. The primary endpoint was successfully met, with the drug detected in all patients sampled. This indicates that SENS-401 can cross the labyrinth barrier when administered orally, a crucial finding for its potential use in hearing preservation.

The study also included several secondary endpoints, such as changes in hearing threshold at various frequencies in the implanted ear. As of February 1, 2024, the trial had completed patient enrollment, with 28 patients randomized and 25 receiving cochlear implants. Among them, 16 were in the treatment group and 9 in the control group.

The full dataset, including secondary endpoints, is expected to be published in the third quarter of 2024. Nawal Ouzren, CEO of Sensorion, expressed enthusiasm about the trial's success and the upcoming publication of the study's complete findings. The company is grateful for the participation of patients, physicians, and its partner Cochlear Limited.

In 2017, Sensorion and Cochlear entered into a research collaboration agreement for SENS-401. Cochlear has the option to negotiate a global license for the distribution of SENS-401 related to certain implantable devices once the study's complete readout is available.

SENS-401, also known as Arazasetron, is Sensorion's lead drug candidate. It is an orally administered small molecule designed to protect inner ear tissue from damage that leads to progressive hearing loss. The drug is currently in Phase 2a trials for preventing residual hearing loss in cochlear implant patients and for preventing Cisplatin-Induced Ototoxicity. It has received Orphan Drug Designation by both the EMA and the FDA for specific hearing loss treatments.

Sensorion is dedicated to developing novel therapies for hearing loss disorders, addressing a significant global medical need. The company has established a unique R&D platform to enhance its understanding of inner ear diseases, allowing it to select optimal drug targets. In addition to SENS-401, Sensorion is developing gene therapy programs for hereditary forms of deafness in collaboration with the Institut Pasteur. The company is also engaged in identifying biomarkers to improve the diagnosis of hearing loss disorders.

Sensorion's commitment to advancing hearing health is evident through its diverse clinical-stage portfolio, which includes SENS-401 in Phase 2 trials for ototoxicity and cochlear implant patients, as well as other small molecule programs for hearing loss treatment and prevention. The company's dedication to innovation and partnership is set to bring promising solutions to those affected by hearing loss.