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Sensorion Receives European Authorization to Initiate SENS-401 Phase 2 Trial in Sudden Sensorineural Hearing Loss
- Sensorion’s 2nd European Voluntary Harmonization Procedure Application Approval
- International Multicenter Phase 2 with SENS-401 for Treating Sudden Sensorineuronal Hearing Loss in Adults to Start
MONTPELLIER, France, Aug. 20, 2018 (GLOBE NEWSWIRE) -- Sensorion (FR0012596468 – ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announces that the HMA (Heads of Medicines Agencies, a European network of the Heads of the National Competent Authorities) approved the company’s Volunturary Harmonization Procedure (VHP) application to initiate a Phase 2 clinical trial for SENS-401 in the treatment of sudden sensorineural hearing loss (SSNHL) in adults.
The randomized, double-blind, placebo-controlled Phase 2 study will be conducted across 50 sites in Europe, the U.S., Canada, Israel, and Turkey, and enroll approximately 260 patients. The Company aims for a study start (first patient in) in Q4 2018, and interim topline data in Q4 2019. Principal investigator is Prof. Dr. Arne Ernst, Professor and Chairman, Dept. Otorhinolaryngology at UKB, the teaching hospital of the Berlin Charité Medical University and the Alice Solomon Hochschule Clinical Centre, and Past/Honorary Chairman of the German Society of Audiology, Neurotology &Otology (ADANO), and EAONO (European Academy for Otology and Neurotology).
SENS-401 has received Orphan Drug Designation in Europe for the treatment of SSNHL, and for platinum-induced ototoxicity in pediatric populations in the US.
SENS-401 is Sensorion’s second product candidate to enter Phase 2 for orally-delivered treatment of inner ear diseases. SENS-111, the Company’s first product, is currently evaluated in an international – multicenter, placebo-controlled Phase 2 trial in vertigo caused by acute unilateral vestibulopathy (AUV).
The VHP enables Sensorion to conduct its clinical trial in all European Union countries. This procedure considerably simplifies the trial’s organization, because a single country’s competent authority coordinates requests and interactions between national drug agencies and Sensorion, and issues a joint opinion. Importantly, the VHP allows the trial to be conducted with a single clinical protocol in all European countries involved.
“We are excited to be moving SENS-401 to the next stage of clinical development as a potential first-in-class therapy for the treatment of sudden sensorineural hearing loss. Currently there are no treatments available for patients with SSNHL,” said Nawal Ouzren, Sensorion’s Chief Executive Officer. “Our second VHP approval demonstrates our team’s capacity to successfully bring drug candidates to the clinical development stage, and advance the development of therapies for patients with debilitating inner ear disorders.”
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 pediatric 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.
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|Investor Relations – International|
LifeSci Advisors LLC
Chris Maggos - Managing Director, Europe
Tél. : +41 79 367 6254
|Libellé : SENSORION|
Code ISIN : FR0012596468
Mnémonique : ALSEN
Caroline Carmagnol & Wendy Rigal
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 September 6, 2017 under n°R.17-062 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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