Sensorion’s SENS-111 (Seliforant) has failed to meet primary endpoint in the phase 2b proof-of-concept trial to treat acute unilateral vestibulopathy (AUV).
SENS-111 is an orally available small molecule histamine type 4 receptor antagonist, which delivers an inhibitory effect on vestibular neuron activity.
According to the company, the SENS-111 was safe and well tolerated, but did not achieve the primary endpoint of vertigo intensity.
The primary endpoint was measured by the area under the curve of the vertigo intensity visual analogue scale (VI-VAS) in standing position during the four treatment days, with eight post baseline assessments.
The randomised, double-blind, placebo-controlled study, which included three parallel arms, assessed the efficacy and safety of SENS-111 histamine H4 receptor antagonist.
With a 1:1:1 randomisation ratio, Sensorion recruited 105 patients in the phase 2b trial at the centres in Europe, Israel, South Korea and the US. The patients were stratified by duration of vertigo before treatment.
Each patient took part in the study for four weeks, with four days of double-blind treatment and a follow up with no investigational product until 28 days following inclusion.
Sensorion CEO Nawal Ouzren said: “We are disappointed that the clinical endpoint was not met. As already announced before today’s readout, we had not planned to further develop the compound.
“Sensorion is building a leadership position in hearing loss therapies with a promising pipeline of innovative therapeutic solutions to restore, treat and prevent within in the field of inner ear disorders and we are supported by leading academic and industry collaborations.”
Sensorion is a clinical-stage biotech company that has expertise in the development of novel therapies to restore, treat and prevent hearing loss disorders.
The company’s clinical-stage portfolio includes s one phase 2 product called SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL).
In July this year, Sensorion secured the investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.