Sensorion annonce les conclusions positives du Data Safety Monitoring Board (DSMB) et la poursuite de l’étude clinique de phase 2 du SENS-111 dans la vestibulopathie unilatérale aiguë (AUV). 86 patients enrôlés sur l’étude clinique de SENS-111
2019-05-15 · Sensorion SA · original sensorion.com ↗
Press release 1/2 Sensorion announces the positive Data Safety Monitoring Board (DSMB) review and continuation of the phase 2 clinical trial for SENS-111 in acute unilateral vestibulopathy (AUV) 86 patients enrolled in SENS-111 clinical trial Montpellier, 15 May 2019 – Sensorion (FR0012596468 – ALSEN) a pioneering clinical -stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo , today announced that the independ ent Data Safety Monitoring Board (or DSMB) has undertaken a review of the s afety data for the 76 first patients having completed the phase 2 clinical trial for SENS-111 in the treatment of acute unilateral vestibulopathy (AUV). The DSMB has confirmed the absence of any concern as to the safety of SENS 111 an d has recommended continuing the trial as scheduled and enrolling the remaining patients. 86 patients have been enrolled so far. The number of expected patients is some 100 in the centers open in the US, Europe, Israel and South Korea. Sensorion is thus well ahead in achievement of this trial and we confirm that the trial results will be available in the second half of 2019 in order to assess the efficacy of the candidate drug. About Seliforant Seliforant (formerly SENS-111) is the first representative candidate of the histamine type 4 receptor antagonist class to be tested for the symptomat ic treatment of vertigo crises. Displaying a neuromodulation effect of the sensorineural inner ear cell function, S eliforant is a small molecule that can be taken orally or via a standard injection, and is currently in a separate Phase 2 clinical trial, be ing conducted in the United States, Europe , Israel and South Korea. About Sensorion Sensorion is a pioneering clinical -stage biopharmaceutical company, which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, vertigo and tinnitus. Our clinical-stage portfolio includes two phase 2 products: Seliforant (SENS -111) in acute unilateral vestibulopathy and Arazasetron (SENS -401) for sudden sensorineural hearing loss (SSNHL). We have built a unique R&D technology platform to expand our understanding of the pathophysi ology and etiology of inner ear diseases enabling us to select the best targets and modalities for drug candidates. We also identify biomarkers to improve diagnosis and treatment of these underserved illnesses. We are uniquely placed through our platforms and pipeline of potential therapeutics to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders; a significant global unmet need in medicine today. www.sensorion-pharma.com Press release 2/2 Contacts Sensorion Nawal Ouzren CEO [email protected] Tel: +33 467 207 730 Catherine Leveau Financial communication [email protected] Tel: +33 467 207 730 Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN 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 7th, 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 .
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