SENS-401 Delivers Positive Phase 2a Clinical Results: Sensorion Paves the Way for New Hope in Treating Hearing Loss!

Sensorion, a leading biotechnology innovator in hearing loss therapies, is thrilled to present promising initial findings from its Phase 2a study of SENS-401 to protect residual hearing after cochlear implant surgery. On July 5th, 2023, Sensorion is hosting a webinar featuring key opinion leader insights into the efficacy of SENS-401. Don’t miss this special event to learn more about the exciting prospects of SENS-401!

The Phase 2a trial is an innovative, multicenter, randomized, controlled, and open-label investigation designed to evaluate the efficacy of SENS-401 when administered orally twice daily for seven days prior to cochlear implantation in adults suffering from moderately severe to profound hearing impairment.

The study will focus on detecting the presence of SENS-401 in the perilymph 7 days after the administration began, continuing for an additional 42 days. Furthermore, the secondary endpoints measure the change in hearing threshold from baseline to the end of the study in the implanted ear in multiple frequency ranges.

Preliminary results

Five patients taking part in the study have confirmed the therapeutic efficacy of the drug SENS-401 within their perilymph – tackling the issue of residual hearing preservation – only seven days after initially initiating the study. These results, marking a breakthrough in the medical field, are highly encouraging and provide a great beacon of hope to those suffering from partial hearing loss.

M.D. Géraldine Honnet, Sensorion’s Chief Medical Officer, was delighted to report the findings from their clinical trial, which showed that SENS-401 had been successfully detected in the cochlea of 100% of patients who underwent cochlear implantation surgery.

This remarkable result bolsters Sensorion’s goal of providing treatments for those suffering from hearing-loss disorders. The company will be hosting a key Opinion Leaders webinar on 5th July 2023 to discuss further data from its SENS-401 Phase 2A study in the context of cochlear implants.

Professor Yann Nguyen, M.D., Ph.D., an ENT Surgeon at the Otolaryngology Department of the Hospital Pitié Salpêtrière in Paris, France, has expressed his enthusiasm for the preliminary data of SENS-401, which showed a promising clinical profile for patients scheduled for cochlear implantation. He believes that SENS-401 holds the potential to make a substantial impact for those suffering from hearing loss. As such, he looks forward to the further gathering of data on SENS-401.

Sensorion’s KOL webinar, held on July 5, 2023, will feature a presentation by KOL Professor Yann Nguyen M.D., Ph.D., who will provide an overview on the importance of residual hearing preservation and the surgical procedure developed for perilymph sampling.

Sensorion’s management team will communicate further analysis of the preliminary results of the POC Phase 2a study of SENS-401 for the residual hearing preservation in patients who, due to moderately severe to profound hearing impairment, are scheduled for cochlear implantation. The study has been developed with Sensorion’s partner, Cochlear Ltd., the global leader in implantable hearing devices.

Dr Yann Nguyen leads a cutting-edge research and clinical team, tackling some of the most complex and debilitating issues related to hearing loss. His Otolaryngology group, based at the prestigious Hospital Pitié Salpêtrière (Sorbonne Université, AP-HP) in Paris, focuses on middle ear surgery, cochlear implantation, and lateral skull base surgery.

With a Ph.D. in the robot-based surgery for cochlear implantation, his work with the Hearing Institute (Institut Pasteur/Inserm) aims to bridge the gap between lab bench and the operating room. As the head of the innovative ‘RobOtol project’, Dr Nguyen and his team are developing revolutionary solutions to address hearing loss.

About SENS-401

Sensorion’s clinical stage lead drug candidate, SENS-401 (Arazasetron), is an orally available small molecule that aims to protect and preserve precious inner ear tissue, helping to prevent progressive or consequent hearing impairment. To further explore its potential for hearing protection, the drug candidate is currently being developed in a Phase 2a trial to prevent residual hearing loss during cochlear implantation, as well as a Phase 2 trial for preventing Cisplatin-Induced Ototoxicity.

In recognition of SENS-401’s potential, it has been granted Orphan Drug Designation both in Europe (for sudden sensorineural hearing loss) and in the United States (for platinum-induced ototoxicity in pediatric populations).

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.

Sensorion is dedicated to revolutionizing the field of hearing loss disorders and is leading the way, with two innovative gene therapy programs developed in collaboration with the Institut Pasteur. OTOF-GT and GJB2-GT are designed to tackle hereditary monogenic forms of deafness caused by mutations in the otoferlin and GJB2 genes respectively.

Furthermore, Sensorion is continuing its research to identify biomarkers to assist in diagnoses of deafness. Additionally, the company is looking towards small molecule drug programs for the treatment and prevention of hearing loss disorders.

Sensorion has an impressive clinical-stage portfolio, including its Phase 2 product SENS-401 (Arazasetron). This product is currently being studied in a planned Phase 2 proof of concept clinical trial with Cisplatin-Induced Ototoxicity (CIO) as the target condition. The company has also partnered with Cochlear Limited to study the effects of SENS-401 on patients scheduled for cochlear implantation.

In 2021, a Phase 2 study of SENS-401 was completed in Sudden Sensorineural Hearing Loss (SSNHL). These trials demonstrate Sensorion’s commitment to developing innovative treatments that could make a big impact in the healthcare space.

Leave a Comment