Sensorion’s vertigo drug hits tolerability endpoint in phase 2

A phase 2a trial of Sensorion’s vertigo seliforant has met its primary tolerability endpoint. The trial found the histamine type 4 receptor antagonist had no effect on vigilance and cognitive performance, suggesting it may have an edge over existing vertigo treatments such as meclizine.

Meclizine, a histamine H1 receptor antagonist, is used to treat acute vertigo but can cause sedation, impaired motor function and other side effects. These adverse events are particularly problematic in the treatment of vertigo as sedated patients are unable to start the vestibular rehabilitation therapy that could help alleviate their disorders.

France’s Sensorion thinks seliforant, a small molecule formerly known as SENS-111, can inhibit vestibular neuron activity and thereby treat vertigo without causing the sedation associated with the off-label use of meclizine.

To test that idea, Sensorion enrolled 32 people in a crossover trial and randomized them to receive one of two doses of seliforant, meclizine or placebo one week apart in a random order. The subjects were healthy volunteers who were exposed to "experimental motion." Sensorion assessed the effect of the drugs on people using a psychomotor test battery and a vigilance and tracking test.

Sensorion is yet to share data from the trial but has disclosed that the study "met its tolerability primary endpoint in a statistically significant manner." Unlike meclizine, seliforant was not linked to negative CNS side effects.

The finding is small, but given Sensorion’s positioning of seliforant, it's an important step in the advance of the candidate. CNS side effects would have undermined a key plank of Sensorion’s pitch to get seliforant established in the vertigo market.

None of that will matter if seliforant falls short on the efficacy front, though. The big test of that aspect of the drug will come in the second half of next year when Sensorion releases data from an ongoing phase 2 proof-of-concept clinical trial. 

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