Sensorion, a biotech company specializing in the development of treatments of inner ear diseases, has 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 modeling of Seliforant in healthy subjects.
According to a company press release describing the study, a total of 100 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; 200-250 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 modeling determined plasma concentrations and doses for future efficacy studies in patients with vertigo symptoms.
Seliforant (formerly SENS-111) 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. According to Sensorion, Seliforant 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.
“For patients suffering from vertigo crises, there are currently no efficacious treatment options to alleviate the debilitating symptoms characteristic of this condition,” said Sensorian CEO Nawal Ouzren in a press statement. “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.”
Sensorion has been listed on the Euronext Growth Paris exchange since April 2015. The company also initiate in August 2018 a Phase 2 clinical trial for SENS-401 for the treatment of sudden sensorineural hearing loss (SSNHL) in adults and is working with Cochlear Corp in what it has described as a “collaboration at the intersection between medtech and biotechnology.”