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SENS-401

Introduction

What is SENS – 401 ?

SENS-401 is a first-in-class drug candidate to treat Sudden Sensorineural Hearing Loss (SSNHL). It is aiming at treating or protecting against inner ear lesions that lead to nerve degeneration and sensory hair cell loss. It is protected by a solid intellectual property with two patent families.

Structure

Composition

  • R-azasetron besylate (a Serotone® enantiomer marketed for chemotherapy-induced nausea and vomiting)
  • A 5-HT3 receptor antagonist (setron family) and calcineurin inhibitor. Small molecule administered orally or by injection

Diagram

Mechanism of action

Promising trials

A Phase 1 trial showed good tolerance to SENS-401

  • Clinical trial on 36 healthy volunteers
  • Double blind, randomized, multiple ascending dose study
  • No significant adverse event reported and a safety profile comparable to placebo
  • Pharmacokinetics matching systemic effective exposure obtained in preclinical model

Introduction

What is SENS – 401 SSHNL ?

SENS-401 is our lead candidate to treat sudden sensorineural hearing loss (SSNHL).

 

Key Opinion Webinar on SSNHL and SENS-401 as a potential treatment option
Listen to the presentation

Preclinical results

A daily oral administration of SENS-401 (13.2 mg/kg bid) reduces auditory
deficit and improves recovery

Study introduction

 

 

AUDIBLE-S Phase 2  results

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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PATRIOT Consortium

The PATRIOT consortium consists of Sensorion, the French Army Biomedical Research Center (IRBA), Institut Pasteur and Electronique du Mazet (Echodia), a French MedTech company focusing on hearing assessment and diagnostics. This project has a collaborative research and development structure in order to respond to the existing high unmet medical need in acute acoustic trauma. The PATRIOT consortium contributes to the development of SENS-401 as a treatment option, up to regulatory approval. The French government has awarded the PATRIOT consortium a ‘Structural Research and Development Project for Competitiveness’ (PSPC) grant with non-dilutive funding of up to €10.8m over the duration of the project. Sensorion could receive up to €5.6m. This grant will be used to finance the development of SENS-401 in SSNHL, including work by Institut Pasteur to identify response biomarkers. The commitment and active involvement of the French ministry of Armed Forces in this project emphasizes a clear unmet medical need and the necessity to have efficient diagnostics and therapeutic solutions. Auditory deficit is an invisible injury causing disabilities and potential social isolation.

Regulatory approvals

  • Orphan Drug Designation from European Medicines Agency (EMA)
  • Pediatric Investigation Plan approved by the European Medicines Agency (EMA)

Introduction

What is SENS – 401 CIO ?

We are developing SENS-401 in the prevention of hearing loss due to Cisplatin-Induced Ototoxicity.

 

KOL webinar on CIO
Webinar final slides (English)
Listen to the presentation

Preclinical results

 

Regulatory approvals

  • Orphan Drug Designation from Food and Drug Administration (FDA)
  • Pediatric Investigation Plan approved by the European Medicines Agency (EMA)

Introduction

What is SENS-401 Cochlear ?

We are investigating SENS-401’s otoprotective potential in patients with cochlear implants in collaboration with Cochlear, the global leader in implantable hearing solutions.

Results

We announced positive preclinical data demonstrating SENS-401 potential to preserve residual hearing after cochlear implantation. Following this initial success, we are initiating a Phase 2a clinical trial with our partner, Cochlear LTD.