Sensorion, a clinical-stage biotechnology company at the forefront of developing novel therapies for the treatment of hearing loss disorders, is pleased to announce that the first patient has been enrolled in its Phase 2a Proof of Concept clinical trial of SENS-401 (Arazasetron) in patients suffering from Cisplatin-Induced Ototoxicity. This groundbreaking clinical trial is an exciting step forward in Sensorion’s mission to restore, treat, and prevent hearing loss disorders.
Cisplatin and other platinum-based compounds are powerful chemotherapeutic agents for many types of cancer, but unfortunately, they can also cause permanent and irreversible hearing loss in up to 50-60% of adult patients and an astonishing 90% of pediatric patients. This ototoxicity represents an unfilled need for these cancer survivors and is a large potential market with an estimated incidence of over 500,000 patients in the US, EU, and Japan.
NOTOXIS, a groundbreaking Phase 2a, multicenter, randomized, controlled, and open-label study, is investigating the potential of SENS-401 to protect adult patients with a neoplastic disease from the ototoxicity caused by cisplatin. This is an exciting exploration into a novel treatment option!
The growing need for a solution to Cisplatin-Induced Ototoxicity is pressing, and Sensorion’s Chief Medical Officer Géraldine Honnet is determined to find one. Cisplatin is a highly effective treatment for many cancers, but unfortunately it comes with a risk of hearing loss for adult and pediatric patients. Sensorion has conducted extensive preclinical and clinical studies on its SENS-401 candidate, which has given them the confidence to begin a formal trial that could potentially preserve hearing for patients receiving cisplatin, without compromising its effectiveness. It’s an exciting time for Sensorion and those looking for a potential solution to Cisplatin-Induced Ototoxicity.
In the Petremann et al. (2017) preclinical model of Cisplatin-Induced Ototoxicity, SENS-401 showed a remarkable ability to significantly reduce hearing loss. Moreover, the AUDIBLE-S study earlier this year revealed that SENS-401 had a statistically significant and clinically meaningful effect of at least 10 dB when compared to placebo. This was seen in 81 patients who were treated with corticosteroids, which represented 70% of the Intent to Treat population. These results have enabled the NOTOXIS trial to extend treatment and focus on preventing hearing loss.
After much anticipation, the NOTOXIS amended clinical trial application (CTA) was finally approved in October 2022 in France and December 2022 in Israel, marking a major milestone for the company.
The upcoming clinical trial will assess the efficacy of SENS-401 in protecting hearing loss in patients undergoing cisplatin-based chemotherapy. 58 participants will be randomized into two arms: Arm A, who will receive cisplatin-based chemotherapy without SENS-401, and Arm B, who will receive 43.5 mg of oral SENS-401 1 week prior to the initiation of the cisplatin treatment and during the entire duration of the treatment. The primary objective of the study is to measure the change from baseline in the average of the Pure Tone Audiometry (PTA) 4 weeks after the completion of the cisplatin treatment. Join us in uncovering the potential of SENS-401 to protect hearing loss in chemotherapy patients!
Sensorion’s upcoming clinical trial will evaluate the efficacy of their drug in reducing the symptoms of acute inner ear damage. In addition to the primary outcome measure, the trial will assess the rate and severity of ototoxicity, the change in PTA (dB) throughout the study, and tolerance. Excitingly, the company expects to publish interim data in the first half of 2023, giving a glimpse of the potential impact of the drug.
Sensorion is advancing the development of SENS-401, an orally available small molecule, in two Phase 2 clinical trials. This clinical stage lead drug candidate has the potential to protect and preserve inner ear tissue from progressive or sequelae hearing impairment, as well as prevent residual hearing loss in patients scheduled for cochlear implantation and Cisplatin-Induced Ototoxicity. With SENS-401, Sensorion is aiming to revolutionize the way hearing impairment is treated.
SENS-401 has been given a special seal of approval from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The FDA granted Orphan Drug Designation to SENS-401 for the prevention of platinum-induced ototoxicity in pediatric patients, while the EMA gave it the same designation for the treatment of sudden sensorineural hearing loss. This important recognition highlights the potential of SENS-401 to provide effective solutions for these medical conditions.
Sensorion is a groundbreaking clinical-stage biotech company taking the lead in restoring, treating and preventing hearing loss disorders – an immense global unmet medical need. By developing innovative therapies, Sensorion is paving the way to provide hope to those affected by hearing loss.
At Sensorion, we have developed an advanced R&D technology platform to gain insight into the causes and effects of inner ear-related diseases. Our portfolio incorporates cutting-edge small molecule and inner ear gene therapies – enabling us to identify the most effective targets and mechanisms of action for drug candidates. Our research is revolutionizing the way we approach and treat inner ear-related conditions.
Sensar has an impressive clinical-stage portfolio, including its Phase 2 product SENS-401 (Arazasetron). This cutting-edge product is currently being tested in a Proof of Concept clinical study of Cisplatin-Induced Ototoxicity (CIO), and with the assistance of partner Cochlear Limited, a study of SENS-401 in patients scheduled for cochlear implantation. Moreover, a Phase 2 study of SENS-401 in Sudden Sensorineural Hearing Loss (SSNHL) was recently completed in January 2022, paving the way for further development in this area.
Sensorion is teaming up with Institut Pasteur to explore the genetic aspects of hearing loss. Two gene therapy programs, OTOF-GT and GJB2-GT, are being developed to correct hereditary monogenic forms of deafness. These promising treatments could potentially benefit both adults and children suffering from hearing loss related to mutation in the GJB2 gene. Additionally, the collaboration is aiming to identify biomarkers to aid in the diagnosis of these underserved illnesses.
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