Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a biotech company specializing in the treatment of inner ear diseases, announced that it presented data showing that its clinical stage product-candidate SENS-401 demonstrated protective effects in two preclinical models of hearing loss. Data from these studies were presented at the 15th International Conference on Cochlear Implants and Other Implantable Auditory Technologies (Ci2018), at the Flanders Meeting & Convention Center in Antwerp, Belgium, which took place from June 27 to 30, 2018.
According to the company’s press release, data from the presented studies showed that SENS-401 protected inner ear function and enhanced sensory hair cell survival in preclinical models of acoustic trauma and, separately, cisplatin infusion. These data is said to support the potential of SENS-401 as a therapeutic agent that may preserve residual hearing for patients undergoing cochlear implant surgery, an application which is being explored in Sensorion’s partnership with Cochlear Ltd, a medical device company that designs and manufacturers cochlear implant technology.
Nawal Ouzren, Sensorion’s chief executive officer, said: “Sensorion is pleased to have had the opportunity to present its findings at Ci2018 to leaders in the field. We are currently collaborating with Cochlear Ltd, the largest global developer of cochlear implants, and the Phase 1 clinical and preclinical data on SENS-401 presented at this conference continue to validate the rationale behind our collaboration. We are eager to conduct this project to hopefully enable much greater patient access to cochlear implants.”
SENS-401 is a clinical-stage drug candidate that reportedly completed Phase 1 testing in healthy volunteers, demonstrating satisfactory safety and tolerability as well as a favorable pharmacokinetic (PK) profile. The product is expected to enter Phase 2 clinical proof of concept studies in the coming weeks.
Title of the oral presentation: Potential for Pharmacological Protection Against Loss of Residual Hearing After Cochlear Implant Surgery Using the Clinical-Stage Oral Otoprotectant SENS-401
In the preclinical studies, Sensorion used two hearing loss models, acoustic trauma noise-induced hearing loss (NIHL) and cisplatin-induced hearing loss (CIHL), to assess hearing loss and outer hair cell survival in animals treated with SENS-401. Results from both models showed that SENS-401 not only demonstrated strong perilymph and inner ear tissue penetration of 25-30% and 35-50% of plasma levels, respectively, but SENS-401 also significantly reduced hearing loss and enhanced outer hair cell survival in animals exposed to acoustic trauma or cisplatin infusion. Efficacy was measured in terms of both otoacoustic emissions (DPOAE) and auditory evoked potentials auditory (ABR). These data in combination with positive Phase 1 safety and PK profile of SENS-401 support the potential of SENS-401 as a hearing loss treatment.
SENS-401, R-azasetron besylate, is a drug candidate that aims to protect and preserve inner ear tissue when lesions are present that can cause progressive or sequelar hearing impediments. A small molecule that can be taken orally or via an injection, SENS-401 has reportedly received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss, and Orphan Drug Designation from the US FDA for the prevention of platinum-induced ototoxicity in pediatric population.