MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a biotech company specializing in the treatment of inner ear diseases, 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 27th to 30th, 2018.
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 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, the world leader in 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 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.
The International Conference on Cochlear Implants and Other Implantable Auditory Technologies (Ci2018) is a major international event which brings together over 2000 otologists, audiologists and speech pathologists, scientists, educators and industrial partners to share the latest technologies and scientific developments in cochlear implants and other auditory implants. Sensorion presented data from preclinical and clinical studies assessing SENS-401 as an effective 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 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 paediatric population.
Sensorion is a biotech company pioneering novel treatments of inner ear diseases such as severe vertigo, tinnitus or hearing loss. Two products are currently in the clinical development stage: SENS-111, in phase 2 in acute unilateral vestibulopathy (vestibular neuritis), and SENS-401, which has completed a phase 1 trial. The company was founded by Inserm (the French Institute of Health and Medical Research) and is utilizing its pharmaceutical R&D experience and comprehensive technology platform to develop first-in-class easy-to-administer, notably orally active, drugs for treating and preventing hearing loss and the symptoms of bouts of vertigo and tinnitus.
Based in Montpellier, Southern France, Sensorion has received financial support from Bpifrance, through the InnoBio fund, and Inserm Transfert Initiative.
Sensorion has been listed on the Euronext Growth Paris exchange since April 2015.
This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward-looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the Document de référence registration document filed with the Autorité des marchés financiers (AMF- French Financial Market Authority) on July 28, 2016 under n°R.16-069 and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements.
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Label : SENSORION
ISIN : FR0012596468
Mnemonic : ALSEN