MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (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 independent Data Safety Monitoring Board (or DSMB) has undertaken a review of the safety 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 and 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.
Seliforant (formerly SENS-111) is the first representative candidate of the histamine type 4 receptor antagonist class to be tested for the symptomatic treatment of vertigo crises. Displaying a neuromodulation effect of the sensorineural inner ear cell function, Seliforant is a small molecule that can be taken orally or via a standard injection, and is currently in a separate Phase 2 clinical trial, being conducted in the United States, Europe, Israel and South Korea.
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 pathophysiology 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.
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.
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