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Sensorion Announces Publication of Seliforant Phase 1 Study Data in the British Journal of Clinical Pharmacology
Study of safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic modelling of Seliforant
Seliforant was well tolerated, no sedation was reported, and demonstrated a pharmacokinetic profile acceptable for daily oral dosing
MONTPELLIER, France, Sept. 26, 2018 (GLOBE NEWSWIRE) -- Sensorion (FR0012596468 – ALSEN), a biotech company specializing in the development of treatments of inner ear diseases, today announced the publication of data in the British Journal of Clinical Pharmacology from a Phase 1 study evaluating the safety, tolerability, pharmacokinetics and pharmacokinetic‐pharmacodynamic modelling of Seliforant in healthy subjects.
One hundred healthy volunteers were randomized in a placebo‐controlled, double‐blind study evaluating single‐ascending doses (100 to 500 mg) and multiple‐ascending doses (50‐150 mg/day for 4 days; 200 to 250 mg/day for 7 days). Seliforant was well tolerated with only mild to moderate adverse events and no sedation was observed. It also demonstrated an acceptable pharmacokinetic profile for daily oral dosing and the pharmacokinetic-pharmacodynamic modelling determined plasma concentrations and doses for future efficacy studies in patients with vertigo symptoms.
Seliforant is currently being studied in an ongoing Phase 2 trial for the treatment of acute unilateral vestibulopathy, a debilitating disease of the inner ear. Some data are expected at the end of 2018.
“For patients suffering from vertigo crises, there are currently no efficacious treatment options to alleviate the debilitating symptoms characteristic of this condition,” said Nawal Ouzren, Chief Executive Officer of Sensorion. “The inclusion of our study of Seliforant in a prestigious peer-reviewed publication such as the British Journal of Clinical Pharmacology, is a valuable recognition of our work.”
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 Phase 2 clinical trial, being conducted in the United States, Europe and South Korea.
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: Seliforant (SENS-111), in Phase 2 in acute unilateral vestibulopathy (vestibular neuritis), and SENS-401 which has started a Phase 2 in sudden sensorineural hearing loss (SSNHL) in the second half of 2018. 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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Label : SENSORION
ISIN : FR0012596468
Mnemonic : ALSEN
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