Sensorion Announces the Last Patient’s Last Visit in SENS-111 Phase 2 Clinical Trial
MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News:
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 the last patient's last visit in its Phase 2 clinical trial for SENS-111 investigated for the potential treatment of Acute Unilateral Vestibulopathy (AUV).
“We are pleased to announce that 105 patients were enrolled and treated in our SENS-111 Phase 2 trial. The last patient’s last visit of the study took place on October 15th. We remain on track for topline data readout in Q4 2019,” said Nawal Ouzren CEO of Sensorion.
The objective of this proof of concept phase 2, multi-centered, randomized, double-blind, placebo-controlled study is to determine the efficacy of SENS-111 in patients with acute unilateral vestibulopathy. Participants were treated for four days with either one of the two doses of SENS-111 or placebo and followed up to 28 days after the start of treatment. The primary endpoint is vertigo intensity measured using a visual analogic scale and the objective is to achieve 20% improvement versus placebo. A total of 105 patients were included in Europe, Israel, South Korea and the United States.
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 crisis. Seliforant is a small molecule taken orally, displaying an inhibitory effect on vestibular neuron activity.
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) under investigation for 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 physiopathology and etiology of inner ear related 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. Sensorion has launched in the second half of 2019 two preclinical gene therapy programs aiming to correct hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin. 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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