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Sensorion Receives European Authorization to Initiate SENS-401 Phase 2 Trial in Sudden Sensorineural Hearing Loss
?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 devlopment 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.” About SENS-401 About Sensorion 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. Contacts
Disclaimer 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. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. |