Sensorion, a biotech company specializing in the treatment of inner ear diseases, has set-up a phase 2 clinical trial with SENS-111, its drug candidate for acute severe vertigo.
The aim of this international multi-center randomized double-blind placebo-controlled study is to assess the efficacy and safety of SENS-111 in 207 patients suffering from acute unilateral vestibulopathy, and will be monitored each day during the treatment and up to 28 days thereafter.
Sensorion has already selected 25 specialized centers with substantial expertise in caring for patients with vestibular pathologies in the United States, Europe and South Korea.
Delay due to new formulation of the product in mouth dissolving tablet
The trial is set to last up to two years, with the enrolment of patients suffering from acute unilateral vestibulopathy due to begin during the first quarter of 2017. This slight delay compared with the initial schedule is due to the manufacturing of the new formulation of the product in mouth-dissolving (orodispersible) tablet form, which is particularly suited to these patients who also suffer from nausea and vomiting.
Laurent Nguyen, CEO of Sensorion, said: “We are delighted to be able to launch a phase 2 clinical study of this size with SENS-111 that is a major first in acute severe vertigo. Our preclinical results and the activity signals observed in healthy volunteers during the phase 1b trial are enabling us to make rapid progress with this small orally-active molecule that aims to treat this highly-debilitating pathology for which physicians lack effective and well-tolerated drugs.”
What is acute unilateral vestibulopathy?
Acute unilateral vestibulopathy is a sudden dysfunction of the vestibular system that generates very pronounced symptoms that appear in just minutes, including intense rotary vertigo, nausea and vomiting, but no tinnitus or hearing loss.
The disease occurs between 3.5 and 15.5 cases per 100,000 people per year. Its origin is not as yet fully understood, although the underlying causes may be a viral infection or a vascular origin.
SENS-111 is the first representative of the histamine type 4 receptor antagonist class tested in inner-ear pathologies. This drug candidate displays a neuromodulation effect of the sensorineural inner ear cell function and is being developed for the symptomatic treatment of vertigo crises or tinnitus. SENS-111 is a small molecule that can be taken orally or via a standard injection, and has been successfully assessed in humans in phase 1b.