What is SENS-401?

A first-in-class drug to treat Sudden SensoriNeural Hearing Loss (SSNHL):

  • To protect against inner ear lesions that lead to nerve degeneration and hair cells loss
  • Received Orphan Drug Designation in Europe for treating SSNHL

R-azasetron besylate (an enantiomer of Serotone® marketed in Asia for chemotherapy-induced nausea and vomiting).

A 5-HT3 receptor antagonist and calcineurin inhibitor.

Small molecule administered orally or by injection.


Preclinical and Clinical Data

Positive preclinical and early clinical data paved the way for initiating further clinical evaluation.
  • Potent capacity to reduce hearing loss in preclinical studies
  • Good inner ear exposure after systemic administration in preclinical studies
  • A phase 1 trial showed good tolerance and confirmed pharmacokinetics at higher doses than those usually prescribed with R/S azasetron [Clinicaltrials.gov/SENS-401]

A phase 2 study is initated in Europe.

 

About Sudden SensoriNeural Hearing Loss (SSNHL)

SSNHL is also known as sudden deafness and belongs to the group of rare conditions that affect the inner ear

  • Rapid (instant or in <72 hours) hearing loss typically unilateral
  • Loss of >30 decibels (a 1000-fold reduction of sound perception)
  • Often accompanied by tinnitus and vertigo
  • Most commonly affects people over 45 years of age

SSNHL occurs with the destruction of sensory hair cells (sound detectors), the sensory neurons (conducting auditory information to the brain), or their connections.

While the cause of most cases (71%) in unknown (idiopathic), other possible causes include

  • Infectious (12.8%) or otologic (4.7%) diseases
  • Traumatic injury including noise (4.2%)
  • Vascular/hematologic (2.8%)
  • Neoplasia (2.3%)
  • Other (2.2%)

No treatments are currently available for SSNHL

 

SENS-401 and its therapeutic area are protected by several patent families.

 

Reference:
Stachler et al., (2012). Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 146(3 Suppl):S1-35. Pubmed

Latest news

  • 02 Apr 2020

    Sensorion reports full-year 2019 financial results and business update Solid €30m cash position at year end and runway increased to beginning of Q3 2021. Read

  • 13 Mar 2020

    Sensorion provides update on SENS-401 SSNHL Phase 2 AUDIBLE-S trial enrollment. Read

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